Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT01238172
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 478
• Locations: 180
• Arms: 2
• Actual Duration (Months): 96.5
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.

PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: dietary education and counseling; Other: prostate cancer foundation booklet	Phase 3

Detailed Description

CALGB 70807 is a randomized, phase III clinical trial designed to test this practical, diet-based intervention for prostate cancer in a broader clinical setting. Patients on AS will be randomized either to an intervention of centralized, telephone-based dietary counseling and structured dietary education or to a comparison control condition in which they receive the Prostate Cancer Foundation booklet. Study endpoints will include disease progression, incidence of treatment, and health-related quality of life.

OBJECTIVES:

Primary

• To determine if a telephone-based dietary intervention compared to no intervention will decrease clinical progression in AS patients.

Secondary

• To compare the incidence of active treatment (surgery, irradiation, local ablation, or androgen deprivation) in AS patients receiving dietary intervention compared to no intervention.

• To compare prostate cancer-related anxiety in AS patients receiving dietary intervention compared to no intervention.

• To compare health-related quality of life in AS patients receiving dietary intervention compared to no intervention.

OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 70 years vs

70 years), race (black or african american vs other), and baseline prostate biopsy (0-12 months before registration vs > 12-24 months before registration). Patients are randomized to 1 of 2 treatment arms. Please see the arms section for more information.

Study Design

• Study Type: Interventional
• Actual Enrollment: 478 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance
• Actual Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Nov 18, 2017
• Actual Study Completion Date: Jan 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A - MEAL Program Intervention Patients will receive dietary education and telephone counseling sessions over 24 months.	Other: dietary education and counseling
Experimental: Arm B - Prostate Cancer Foundation Booklet Patients receive information about diet, nutrition, exercise and cancer. Patients also receive regularly scheduled newsletters.	Other: prostate cancer foundation booklet

Outcome Measures

Primary Outcome Measures

1. Time to Progression [Up to 2 years]

   Time to progression (TTP) was defined as the length of time from the date of random assignment to progression; patients who died from any cause without experiencing disease progression were censored at the time of death. Disease progression is defined by (a) PSA doubling time (PSADT) less than 3 years, (b) PSA above 10 at any time, or (c) Gleason score on repeat biopsy ≥ 7 for men 70 years or younger and ≥ 4+3 = 7 for men older than 70 years. For the primary analysis, TTP was analyzed using the Kaplan-Meier method; the log-rank test was used to determine superiority of the intervention arm (Arm A: MEAL Program Intervention) compared with the control arm (Arm B: Prostate Cancer Foundation Booklet).

Secondary Outcome Measures

1. Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed [Up to 2 years]

   Time to treatment was analyzed by the Kaplan-Meier method. For this analysis, patients who did not withdrawal from the study to pursue treatment were censored at the time of clinical progression, death, or their last follow-up visit, whichever occurred first. The number of patients who observed an event (treatment) are summarized below.

2. Quality of Life (QOL) Was Measured Using Change From Baseline in Total Summary Score of Memorial Anxiety Scale for Prostate Cancer (MAX-PC) at Month 24 [Up to 2 years]

   Quality of Life (QOL) was measured using Observed Total Summary Score of Memorial Anxiety Scale for Prostate Cancer [MAX-PC] at Month 24 on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. MAX-PC is a prostate cancer-specific measure to assess patient anxiety due to prostate cancer, PSA tests and fears of recurrence. Change from baseline to month-24 was calculated by subtracting the baseline scores from the scores at month-24. Higher scores on MAX-PC indicate better QOL

3. Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall [Up to 2 years]

   At baseline and 24 months, participant diet including total vegetables (servings/day) was measured with a series of three separate interviews at each time point, on three-randomly selected days in a single week, using the Nutrition Data Systems for Research (NDS-R, current version 2010, University of Minnesota Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and nutrient database. Total vegetables were measured as the number of servings per day (range: ≥ 0), where higher values correspond to more servings per day. The within-participant change from baseline at 24 months was calculated by subtracting the baseline number of servings per day from the number of servings per day at month 24; positive values correspond to increased consumption of total vegetables.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Preregistration Eligibility:

1. Histologic Documentation:

• The initial biopsy showing diagnosis of prostate cancer should be used for the purposes of determining eligibility.

• However, if a subsequent biopsy performed before patient enrollment shows that the patient is ineligible, he may not be enrolled to the study.

• Eligible patients must meet all of the following criteria:

• Biopsy-proven (consisting of ≥ 10 tissue cores) adenocarcinoma of the prostate diagnosed within 24 months prior to pre-registration

• < 25% of biopsy tissue cores positive for cancer

• ≤ 50% of any one biopsy tissue core positive for cancer

• Clinical stage ≤ T2a

• Patients who have prostate cancer with distant metastases are not eligible

• NOTE: If a patient undergoes a transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH), and prostate cancer is diagnosed incidentally from the TURP specimen, eligibility for CALGB 70807 cannot be determined from the TURP specimen. However, if the patient subsequently undergoes a minimum 10-core prostate biopsy within 2 years of prostate cancer diagnosis from the TURP, and prostate cancer is detected in the biopsy specimen and meets the requirements above, the patient is eligible for this study. If prostate cancer is not detected in the biopsy specimen, the patient is not eligible.

1. Prior Treatment: Patients who have had prior treatment for prostate cancer by surgery, irradiation, local ablative (i.e. cryosurgery or high-intensity focused ultrasound) or androgen deprivation therapy are not eligible.

2. Patients who have had a history of non-cutaneous malignancy (other than nonmelanoma skin cancer) in the previous 5 years are not eligible.

3. Language: Patients must be able to read and comprehend English language text and be able to understand spoken English over the phone.

4. Life expectancy of at least 3 years

5. Patients who are currently taking vitamin supplements including lycopene and beta-carotene are eligible.

6. Patients receiving treatment with 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) within 90 days prior to preregistration are not eligible. Treatment with these agents during the protocol intervention is not permitted.

7. Patients who are currently taking coumadin are not eligible.

8. Participants will be men aged 50 to 80 years.

9. For men ≤ 70 years, biopsy Gleason score ≤ 6; for men > 70 years, biopsy Gleason score ≤ (3 + 4) = 7.

10. Required Initial Laboratory Values:

• Serum PSA < 10 ng/mL

• NOTE: Baseline PSA for determination of eligibility must be measured after discontinuation of any 5-alpha reductase inhibitors.

Registration Eligibility:

1. Successful completion of three 24-hour dietary recalls during the run-in period.

2. Patients consuming ≥ 6 servings per day of fruits and vegetables (not including juices), as determined by the run-in dietary recalls are not eligible.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital	Fairbanks	Alaska	United States	99701
2	Mayo Clinic Scottsdale	Scottsdale	Arizona	United States	85259-5499
3	Kaiser Permanente Medical Center - Bellflower	Bellflower	California	United States	90706
4	California Cancer Care, Incorporated - Greenbrae	Greenbrae	California	United States	94904
5	Rebecca and John Moores UCSD Cancer Center	La Jolla	California	United States	92093-0658
6	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California	United States	92354
7	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California	United States	90027
8	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
9	Saint Helena Hospital	Saint Helena	California	United States	94574
10	Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego	San Diego	California	United States	92120
11	Naval Medical Center - San Diego	San Diego	California	United States	92134
12	Veterans Affairs Medical Center - San Diego	San Diego	California	United States	92161
13	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California	United States	94115
14	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado	United States	80045
15	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
16	Front Range Cancer Specialists	Fort Collins	Colorado	United States	80528
17	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
18	Middlesex Hospital Cancer Center	Middletown	Connecticut	United States	06457
19	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware	United States	19958
20	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
21	Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	Florida	United States	33805
22	Florida Hospital Cancer Institute at Florida Hospital Orlando	Orlando	Florida	United States	32803-1273
23	Cleveland Clinic Florida - Weston	Weston	Florida	United States	33331
24	Kapiolani Medical Center at Pali Momi	'Aiea	Hawaii	United States	96701
25	Oncare Hawaii, Incorporated - Pali Momi	'Aiea	Hawaii	United States	96701
26	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813
27	OnCare Hawaii, Incorporated - Lusitana	Honolulu	Hawaii	United States	96813
28	Queen's Cancer Institute at Queen's Medical Center	Honolulu	Hawaii	United States	96813
29	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii	United States	96813
30	OnCare Hawaii, Incorporated - Kuakini	Honolulu	Hawaii	United States	96817-3169
31	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
32	Castle Medical Center	Kailua	Hawaii	United States	96734
33	Kauai Medical Clinic	Lihue	Hawaii	United States	96766
34	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho	United States	83706
35	St. Joseph Regional Medical Center	Lewiston	Idaho	United States	83501
36	Idaho Urologic Institute, PA	Meridian	Idaho	United States	83642
37	Resurrection Medical Center	Chicago	Illinois	United States	60631
38	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
39	Louis A. Weiss Memorial Hospital	Chicago	Illinois	United States	60640
40	Veterans Affairs Medical Center - Hines	Hines	Illinois	United States	60141
41	La Grange Memorial Hospital	La Grange	Illinois	United States	60525
42	West Suburban Center for Cancer Care	River Forest	Illinois	United States	60305
43	Bloomington Hospital Regional Cancer Institute	Bloomington	Indiana	United States	47403
44	Elkhart Clinic, LLC	Elkhart	Indiana	United States	46514-2098
45	Michiana Hematology-Oncology, PC - Elkhart	Elkhart	Indiana	United States	46514
46	Elkhart General Hospital	Elkhart	Indiana	United States	46515
47	Howard Community Hospital	Kokomo	Indiana	United States	46904
48	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
49	Michiana Hematology-Oncology, PC - South Bend	Mishawaka	Indiana	United States	46545-1470
50	Saint Joseph Regional Medical Center	Mishawaka	Indiana	United States	46545-1470
51	Michiana Hematology Oncology PC - Plymouth	Plymouth	Indiana	United States	46563
52	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
53	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
54	Michiana Hematology Oncology PC - La Porte	Westville	Indiana	United States	46391
55	McFarland Clinic, PC	Ames	Iowa	United States	50010
56	Wendt Regional Cancer Center at Finley Hospital	Dubuque	Iowa	United States	52001
57	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
58	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
59	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51102
60	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
61	St. Rose Ambulatory and Surgery Center	Great Bend	Kansas	United States	67530
62	Hays Medical Center	Hays	Kansas	United States	67601
63	Hutchinson Hospital Corporation	Hutchinson	Kansas	United States	67502
64	Kansas City Cancer Centers - West	Kansas City	Kansas	United States	66112
65	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
66	Kansas City Cancer Centers - Southwest	Overland Park	Kansas	United States	66210
67	Mount Carmel Regional Cancer Center	Pittsburg	Kansas	United States	66762
68	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas	United States	67401
69	Kansas City Cancer Center - Shawnee Mission	Shawnee Mission	Kansas	United States	66204
70	St. Francis Comprehensive Cancer Center	Topeka	Kansas	United States	66606
71	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky	United States	40536-0093
72	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana	United States	70809
73	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
74	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana	United States	70112
75	Maine Medical Center - Bramhall Campus	Portland	Maine	United States	04102
76	Maine Center for Cancer Medicine and Blood Disorders - Scarborough	Scarborough	Maine	United States	04074
77	York Hospital's Oncology Treatment Center	York	Maine	United States	03909
78	Walter Reed National Military Medical Center	Bethesda	Maryland	United States	20889-5600
79	Union Hospital of Cecil County	Elkton	Maryland	United States	21921
80	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
81	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
82	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
83	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
84	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
85	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
86	Hurley Medical Center	Flint	Michigan	United States	48503
87	Genesys Regional Medical Center	Grand Blanc	Michigan	United States	48439
88	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
89	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
90	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
91	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
92	Foote Memorial Hospital	Jackson	Michigan	United States	49201
93	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
94	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
95	Mercy General Health Partners	Muskegon	Michigan	United States	49444
96	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
97	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
98	Spectrum Health Reed City Hospital	Reed City	Michigan	United States	49677
99	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan	United States	48073
100	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
101	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan	United States	49085
102	Lakeside Cancer Specialists, PLLC	Saint Joseph	Michigan	United States	49085
103	Munson Medical Center	Traverse City	Michigan	United States	49684
104	St. John Macomb Hospital	Warren	Michigan	United States	48093
105	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
106	CentraCare Clinic - River Campus	Saint Cloud	Minnesota	United States	56303
107	Coborn Cancer Center	Saint Cloud	Minnesota	United States	56303
108	Adult and Pediatric Urology, PLLP	Sartell	Minnesota	United States	56377
109	Truman Medical Center - Hospital Hill	Kansas City	Missouri	United States	64108
110	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri	United States	64128
111	Kansas City Cancer Centers - South	Kansas City	Missouri	United States	64131
112	Kansas City Cancer Centers - North	Kansas City	Missouri	United States	64154
113	Kansas City Cancer Centers - East	Lee's Summit	Missouri	United States	64064
114	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri	United States	63110
115	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
116	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
117	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59102
118	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
119	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
120	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
121	Benefis Sletten Cancer Institute	Great Falls	Montana	United States	59405
122	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
123	St. Peter's Hospital	Helena	Montana	United States	59601
124	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
125	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
126	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
127	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
128	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
129	Elliot Regional Cancer Center at Elliot Hospital	Manchester	New Hampshire	United States	03103
130	Foundation Medical Partners	Nashua	New Hampshire	United States	03060
131	Saint Clare's Hospital	Denville	New Jersey	United States	07834
132	Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center	Englewood	New Jersey	United States	07631
133	Somerset Medical Center	Somerville	New Jersey	United States	08876
134	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey	United States	08043
135	Veterans Affairs Medical Center - Buffalo	Buffalo	New York	United States	14215
136	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
137	Monter Cancer Center of the North Shore-LIJ Health System	Lake Success	New York	United States	11042
138	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
139	Don Monti Comprehensive Cancer Center at North Shore University Hospital	Manhasset	New York	United States	11030
140	Mount Kisco Medical Group, PC	Mount Kisco	New York	United States	10549-3417
141	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040
142	New York Weill Cornell Cancer Center at Cornell University	New York	New York	United States	10021
143	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
144	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
145	Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
146	High Point Regional Hospital	High Point	North Carolina	United States	27261
147	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio	United States	44307
148	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
149	Bay Area Hospital	Coos Bay	Oregon	United States	97420
150	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania	United States	18105
151	Cancer Center at Phoenixville Hospital	Phoenixville	Pennsylvania	United States	19460
152	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78209
153	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229-3900
154	Cancer Therapy and Research Center	San Antonio	Texas	United States	78229
155	University Hospital - San Antonio	San Antonio	Texas	United States	78229
156	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah	United States	84112
157	Auburn Regional Center for Cancer Care	Auburn	Washington	United States	98002
158	Overlake Cancer Center at Overlake Hospital Medical Center	Bellevue	Washington	United States	98004
159	Providence Centralia Hospital	Centralia	Washington	United States	98531-9027
160	Providence Regional Cancer Partnership	Everett	Washington	United States	98201
161	St. Francis Hospital	Federal Way	Washington	United States	98003
162	Cascade Cancer Center at Evergreen Hospital Medical Center	Kirkland	Washington	United States	98033
163	Seattle Cancer Care Alliance at EvergreenHealth	Kirkland	Washington	United States	98034
164	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington	United States	98506-5166
165	Good Samaritan Cancer Center	Puyallup	Washington	United States	98372
166	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
167	Virginia Mason Medical Center	Seattle	Washington	United States	98101
168	Pacific Medical Center	Seattle	Washington	United States	98104
169	Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	Washington	United States	98405-3004
170	Allenmore Hospital	Tacoma	Washington	United States	98405
171	CCOP - Northwest	Tacoma	Washington	United States	98405
172	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington	United States	98405
173	Madigan Army Medical Center - Tacoma	Tacoma	Washington	United States	98431
174	St. Clare Hospital	Tacoma	Washington	United States	98499
175	Gundersen Lutheran Center for Cancer and Blood	La Crosse	Wisconsin	United States	54601
176	D.N. Greenwald Center	Mukwonago	Wisconsin	United States	53149
177	Regional Cancer Center at Oconomowoc Memorial Hospital	Oconomowoc	Wisconsin	United States	53066
178	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin	United States	53188
179	Rocky Mountain Oncology	Casper	Wyoming	United States	82609
180	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: J. Kellogg Parsons, MD, MHS, University of California, San Diego

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 26, 2018

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT01238172
• Other Study ID Numbers: CALGB-70807; CALGB-70807; CDR0000687958
• First Posted: Nov 10, 2010
• Last Update Posted: Mar 12, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Alliance for Clinical Trials in Oncology: stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; adenocarcinoma of the prostate
• Additional relevant MeSH terms: Prostatic Neoplasms; Disease Progression

Study Results

Participant Flow

Pre-assignment Detail	Of 602 total patients were pre-registered, only 478 patients were deemed eligible and randomized.

Arm/Group Title	Arm A - MEAL Program Intervention	Arm B - Prostate Cancer Foundation Booklet
Arm/Group Description	Patients will receive dietary education and telephone counseling sessions over 24 months.	Patients receive education material about diet, nutrition, exercise and cancer.
Period Title: Overall Study
STARTED	237	241
COMPLETED	226	217
NOT COMPLETED	11	24

Baseline Characteristics

Arm/Group Title	Arm A - MEAL Program Intervention	Arm B - Prostate Cancer Foundation Booklet	Total
Arm/Group Description	Patients will receive dietary education and telephone counseling sessions over 24 months.	Patients receive education material about diet, nutrition, exercise and cancer.	Total of all reporting groups
Overall Participants	226	217	443
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.7 (6.5)	63.5 (6.6)	63.6 (6.5)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	226 100%	217 100%	443 100%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	1 0.4%	0 0%	1 0.2%
Asian	6 2.7%	9 4.1%	15 3.4%
Black or African American	24 10.6%	26 12%	50 11.3%
Hispanic or Latino	9 4%	7 3.2%	16 3.6%
More than one race	0 0%	2 0.9%	2 0.5%
Native Hawaiian or Pacific Islander	0 0%	1 0.5%	1 0.2%
White	186 82.3%	171 78.8%	357 80.6%
Not Reported	0 0%	1 0.5%	1 0.2%
Region of Enrollment (Count of Participants)
United States	226 100%	217 100%	443 100%
Body Mass Index (BMI) (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	28.7 (5.9)	28.3 (3.7)	28.5 (4.9)

Outcome Measures

1. Primary Outcome

Title	Time to Progression
Description	Time to progression (TTP) was defined as the length of time from the date of random assignment to progression; patients who died from any cause without experiencing disease progression were censored at the time of death. Disease progression is defined by (a) PSA doubling time (PSADT) less than 3 years, (b) PSA above 10 at any time, or (c) Gleason score on repeat biopsy ≥ 7 for men 70 years or younger and ≥ 4+3 = 7 for men older than 70 years. For the primary analysis, TTP was analyzed using the Kaplan-Meier method; the log-rank test was used to determine superiority of the intervention arm (Arm A: MEAL Program Intervention) compared with the control arm (Arm B: Prostate Cancer Foundation Booklet).
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

The primary analysis was based on the modified intention-to-treat (m-ITT) analysis population. The m-ITT population included all randomized patients; however, patients who later became ineligible by eligibility review or centralized pathology review of their baseline tissue specimens were excluded.

Arm/Group Title	Arm A - MEAL Program Intervention	Arm B - Prostate Cancer Foundation Booklet
Arm/Group Description	Patients will receive dietary education and telephone counseling sessions over 24 months.	Patients receive education material about diet, nutrition, exercise and cancer.
Measure Participants	226	217
Median (95% Confidence Interval) [days]	683.0	549.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A - MEAL Program Intervention, Arm B - Prostate Cancer Foundation Booklet
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.76
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed
Description	Time to treatment was analyzed by the Kaplan-Meier method. For this analysis, patients who did not withdrawal from the study to pursue treatment were censored at the time of clinical progression, death, or their last follow-up visit, whichever occurred first. The number of patients who observed an event (treatment) are summarized below.
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

The m-ITT population included all randomized patients; however, patients who later became ineligible by eligibility review or centralized pathology review of their baseline tissue specimens were excluded.

Arm/Group Title	Arm A - MEAL Program Intervention	Arm B - Prostate Cancer Foundation Booklet
Arm/Group Description	Patients will receive dietary education and telephone counseling sessions over 24 months.	Patients receive education material about diet, nutrition, exercise and cancer.
Measure Participants	226	217
Count of Participants [Participants]	3 1.3%	2 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A - MEAL Program Intervention, Arm B - Prostate Cancer Foundation Booklet
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.41
	Confidence Interval	(2-Sided) 95%; 0.23 to 8.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Quality of Life (QOL) Was Measured Using Change From Baseline in Total Summary Score of Memorial Anxiety Scale for Prostate Cancer (MAX-PC) at Month 24
Description	Quality of Life (QOL) was measured using Observed Total Summary Score of Memorial Anxiety Scale for Prostate Cancer [MAX-PC] at Month 24 on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. MAX-PC is a prostate cancer-specific measure to assess patient anxiety due to prostate cancer, PSA tests and fears of recurrence. Change from baseline to month-24 was calculated by subtracting the baseline scores from the scores at month-24. Higher scores on MAX-PC indicate better QOL
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

modified ITT population: Only participants with available data on the individual study measure at baseline and 24 months were included in the analysis.

Arm/Group Title	Arm A - MEAL Program Intervention	Arm B - Prostate Cancer Foundation Booklet
Arm/Group Description	Patients will receive dietary education and telephone counseling sessions over 24 months.	Patients receive education material about diet, nutrition, exercise and cancer.
Measure Participants	150	140
Median (Full Range) [score on a scale]	2.0	2.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A - MEAL Program Intervention, Arm B - Prostate Cancer Foundation Booklet
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.995
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall
Description	At baseline and 24 months, participant diet including total vegetables (servings/day) was measured with a series of three separate interviews at each time point, on three-randomly selected days in a single week, using the Nutrition Data Systems for Research (NDS-R, current version 2010, University of Minnesota Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and nutrient database. Total vegetables were measured as the number of servings per day (range: ≥ 0), where higher values correspond to more servings per day. The within-participant change from baseline at 24 months was calculated by subtracting the baseline number of servings per day from the number of servings per day at month 24; positive values correspond to increased consumption of total vegetables.
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

Participants with available data on the individual study measure at baseline and 24 months were included in the analysis

Arm/Group Title	Arm A - MEAL Program Intervention	Arm B - Prostate Cancer Foundation Booklet
Arm/Group Description	Patients will receive dietary education and telephone counseling sessions over 24 months.	Patients receive education material about diet, nutrition, exercise and cancer.
Measure Participants	233	240
Mean (95% Confidence Interval) [servings per day]	2.01	0.37

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A - MEAL Program Intervention, Arm B - Prostate Cancer Foundation Booklet
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments	Two-sided

Adverse Events

Time Frame	Adverse events were not collected for this study.
Adverse Event Reporting Description	Adverse events were not collected for this study.
Arm/Group Title	Arm A - MEAL Program Intervention		Arm B - Prostate Cancer Foundation Booklet
Arm/Group Description	Patients will receive dietary education and telephone counseling sessions over 24 months.		Patients receive education material about diet, nutrition, exercise and cancer.
All Cause Mortality
	Arm A - MEAL Program Intervention		Arm B - Prostate Cancer Foundation Booklet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Arm A - MEAL Program Intervention		Arm B - Prostate Cancer Foundation Booklet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Arm A - MEAL Program Intervention		Arm B - Prostate Cancer Foundation Booklet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.