PREDICT: Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer

• Sponsor: Dendreon (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01981109
• Collaborator: (none)
• Enrollment: 225
• Locations: 58
• Actual Duration (Months): 66
• Patients Per Site: 3.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary purpose of this research is to describe patient characteristics predictive of an imaging study positive for distant metastases in patients with castration-resistant prostate cancer and no known distant metastases.

Condition or Disease	Intervention/Treatment	Phase
Castration-Resistant Prostate Cancer

Study Design

• Study Type: Observational
• Actual Enrollment: 225 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer
• Actual Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Outcome Measures

Primary Outcome Measures

1. Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration [Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan.]

   The primary endpoint for the study will be the occurrence of an imaging study at baseline that is positive for M1 (yes or no) among all patients in the primary analysis population.The primary analysis population consists of patients who had a current diagnosis of having non metastatic (M0) disease at baseline. These patients underwent imaging scans at baseline and were assessed for metastatic (M1) versus non metastatic (M0) disease.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Written informed consent obtained prior to the initiation of study procedures.

• Men ≥ 18 years of age.

• Histologically documented prostatic adenocarcinoma.

• History of Castration-Resistant Prostate Cancer.

Exclusion Criteria:

• Known M1 disease.

• Undergone imaging study for metastatic prostate cancer ≤ 3 months.

• ECOG performance status ≥ 3.

• Known malignant pleural effusions or ascites.

• Current or prior treatment with investigational therapy for M0 Castration-Resistant Prostate Cancer (Taxotere (docetaxel), Provenge® (sipuleucel-T), Zytiga (abiraterone acetate), Xtandi (enzalutamide), Jevtana (cabazitaxel), or Xofigo (radium Ra 223 dichloride).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alaska Clinical Research Center, LLC	Anchorage	Alaska	United States	99503
2	Urological Associate of Southern Arizona	Tucson	Arizona	United States
3	Sequoia Urology Center	Atherton	California	United States
4	Prostate Oncology Specialist, Inc.	Marina Del Rey	California	United States	90292
5	Sutter Medical Group	Sacramento	California	United States
6	Genesis Research	San Diego	California	United States	92123
7	Urology Associates of San Luis Obispo	Templeton	California	United States	93465
8	The Urology Center of Colorado	Denver	Colorado	United States	80211
9	Advanced Urology, P.C	Parker	Colorado	United States	80134
10	Howard University Hospital	Washington	District of Columbia	United States	20060
11	Urology Center of South Florida	Miami	Florida	United States
12	Idaho Urologic Institute	Meridian	Idaho	United States	83642
13	Comprehensive Urologic Care, SC	Lake Barrington	Illinois	United States	60010
14	Uro Partners/ RMD Clinical Research	Melrose Park	Illinois	United States	60160
15	Associated Urological Specialists, LLC	Palos Heights	Illinois	United States	60463
16	1st Urology, PSC	Jeffersonville	Indiana	United States	47130
17	Northern Indiana Cancer Research Consortium	South Bend	Indiana	United States	46628
18	Kansas City Urology Care, PA	Overland Park	Kansas	United States	66211
19	Cancer Center of Kansas	Wichita	Kansas	United States	67214
20	Jewish Hospital	Louisville	Kentucky	United States	40245
21	Tulane University	New Orleans	Louisiana	United States	70112
22	Highland Clinic	Shreveport	Louisiana	United States	71106
23	Regional Urology, LLC	Shreveport	Louisiana	United States	71106
24	Mid Atlantic Urology Associates	Greenbelt	Maryland	United States	20770
25	Chesapeake Urology Research Associates	Towson	Maryland	United States	21204
26	Michigan Institute of Urology	Troy	Michigan	United States	48084
27	Metro Urology	Plymouth	Minnesota	United States	55441
28	Metro Urology	Woodbury	Minnesota	United States	55125
29	Saint Louis VAMS	Saint Louis	Missouri	United States
30	Southeast Nebraska Cancer Center	Lincoln	Nebraska	United States	68510
31	Urology Center Research Institute	Englewood	New Jersey	United States	07631
32	Delaware Valley Urology, LLC	Mount Laurel	New Jersey	United States	08054
33	Montefiore Medical Center	Bronx	New York	United States	10467
34	National Translational Research Group	East Setauket	New York	United States
35	Integrated Medical Professionals, PLLC	North Hills	New York	United States	11042
36	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York	United States	12601
37	Associated Medical Professionals of NY, PLLC	Syracuse	New York	United States	13210
38	Durham Veterans Affairs Medical Center	Durham	North Carolina	United States	27710
39	Carolina Urology Partners	Gastonia	North Carolina	United States	28054
40	Central Ohio Urology Group	Gahanna	Ohio	United States
41	Clinical Research Solutions	Middleburg Heights	Ohio	United States
42	Stepherson Cancer Center	Oklahoma City	Oklahoma	United States
43	Portland Veterans Administration Medical Center	Portland	Oregon	United States
44	Oregon Urology Institute	Springfield	Oregon	United States	97477
45	Urologic Consultants of SE PA	Bala-Cynwyd	Pennsylvania	United States	19004
46	Urology Health Specialists, LLC	Bryn Mawr	Pennsylvania	United States	19010
47	Lancaster Urology	Lancaster	Pennsylvania	United States	17604
48	Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29572
49	The Conrad Pearson Clinic	Germantown	Tennessee	United States
50	Tennessee Urology Asociates	Knoxville	Tennessee	United States
51	Urology Associates, P.C.	Nashville	Tennessee	United States	37209
52	Urology Clinics of North Texas	Dallas	Texas	United States	75231
53	Houston Metro Urology	Houston	Texas	United States	77027
54	UT Memorial Hermann Cancer Center	Houston	Texas	United States
55	Oncology San Antonio Research LLC	San Antonio	Texas	United States	78240
56	Virginia Urology	Richmond	Virginia	United States	23235
57	Urology of Virginia, PLLC	Virginia Beach	Virginia	United States	23642
58	Medical Oncology Associates	Spokane	Washington	United States	99208

Sponsors and Collaborators

• Dendreon

Investigators

• Study Director: Bruce Brown, MD, Dendreon Pharmaceuticals, LLC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 1, 2014

More Information

Publications

None provided.

• Responsible Party: Dendreon
• ClinicalTrials.gov Identifier: NCT01981109
• Other Study ID Numbers: P12-1
• First Posted: Nov 11, 2013
• Last Update Posted: Aug 28, 2019
• Last Verified: Jul 1, 2019

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Sipuleucel-T
Arm/Group Description	A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer
Period Title: Overall Study
STARTED	225
COMPLETED	1
NOT COMPLETED	224

Baseline Characteristics

Arm/Group Title	Sipuleucel-T
Arm/Group Description	A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer
Overall Participants	225
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 8.9%
>=65 years	205 91.1%
Age (Years) [Mean (Standard Deviation) ]
Total	77.2 (8.8)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	225 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	1 0.4%
Black or African American	51 22.7%
White	173 76.9%
More than one race	0 0%
Unknown or Not Reported	0 0%
Height (Centemeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Centemeters]	175.3 (8.3)
Weight (Kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg]	92.7 (20.1)
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.2 (6.2)

Outcome Measures

1. Primary Outcome

Title	Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration
Description	The primary endpoint for the study will be the occurrence of an imaging study at baseline that is positive for M1 (yes or no) among all patients in the primary analysis population.The primary analysis population consists of patients who had a current diagnosis of having non metastatic (M0) disease at baseline. These patients underwent imaging scans at baseline and were assessed for metastatic (M1) versus non metastatic (M0) disease.
Time Frame	Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan.

Outcome Measure Data

Analysis Population Description

There were 206 patients at baseline that had a valuable data that were assessed. The results were 151 patients that had non-metastatic (M0) and 55 patients that had metastatic disease (M1) disease. The study terminated early therefore no further statistical analysis was performed.

Arm/Group Title	M0- No Distant Metastases	M1-Distant Metastases
Arm/Group Description	A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer	A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer
Measure Participants	151	55
Mean (Standard Deviation) [years]	10.9 (6.4)	8.8 (5.9)

Adverse Events

Time Frame	Adverse Events and Serious Adverse Events were not collected in this trial as investigational treatment was not administered in this study. Patients received commercial Provenge® (sipuleucel-T), therefore all SAEs were reported to the Safety Reporting group following full prescribing directions.
Adverse Event Reporting Description	Adverse Events and Serious Adverse Events were not collected in this trial as investigational treatment was not administered in this study. Patients received commercial Provenge® (sipuleucel-T), therefore all SAEs were reported to the Safety Reporting group following full prescribing directions.
Arm/Group Title	Sipuleucel-T
Arm/Group Description	A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer
All Cause Mortality
	Sipuleucel-T
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Sipuleucel-T
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Sipuleucel-T
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

The study was designed to analyze 1200 patients. Early termination resulted in only 206 patients reporting a definitive diagnosis per imaging scan. Given this much smaller number of patients, the analyses do not provide reliable results.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.