Intensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer

• Sponsor: Fox Chase Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00084552
• Collaborator: (none)
• Enrollment: 116
• Location: 1
• Arms: 2
• Actual Duration (Months): 148.8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) may reduce damage to healthy tissue near the tumor. It is not yet known whether reducing the dose of radiation to erectile tissue will help prevent erectile dysfunction.

PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy alone to see how well it works compared to intensity-modulated radiation therapy with reduced doses to erectile tissue in treating patients with stage II prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Sexual Dysfunction; Sexuality and Reproductive Issues	Radiation: radiation therapy	N/A

Detailed Description

OBJECTIVES:

Primary

• Compare erectile dysfunction in patients with stage T1b-T2c adenocarcinoma of the prostate after treatment with intensity-modulated radiotherapy with vs without dose sparing for erectile tissue.

Secondary

• Compare biochemical freedom from failure rates, as a measure of prostate cancer control, in patients treated with these regimens.

• Compare the quality of life of patients treated with these regimens.

• Determine the association of molecular markers and biochemical freedom from failure rate and other endpoints in patients treated with these regimens.

OUTLINE: This is a randomized, single-blind study. Patients are stratified according to age (≤ 65 vs > 65), prescription radiotherapy dose (74 Gy vs 76 Gy), and frequency of erection during sexual activity within the past 4 weeks (a few times vs sometimes vs most times to always). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.

• Arm II: Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.

Treatment in both arms continues in the absence of unacceptable toxicity or disease metastasis.

Quality of life is assessed at baseline, at 6 and 12 months, and then annually for 4 years

Patients are followed at 3 months and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 2.5 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Outcomes Following Intensity Modulated Radiation Therapy With And Without Erectile Tissue Dose Sparing For Favorable To Intermediate Risk Prostate Cancer
• Actual Study Start Date: Dec 11, 2003
• Actual Primary Completion Date: Aug 24, 2013
• Actual Study Completion Date: May 5, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm I Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.	Radiation: radiation therapy; Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
Experimental: Arm II Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.	Radiation: radiation therapy; Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.

Outcome Measures

Primary Outcome Measures

1. Erectile Dysfunction Rates [5 year duration after completion of radiotherapy]

   Postage Stamp Test -A row of stamps is placed around the base of the penis and the ends are moistened and joined. If the circle is broken in the morning then the subject was recorded as having had a nocturnal erection International Index of Erectile Function (IIEF) Questionnaire 15-item questionnaire that measures erectile function Includes companion questionnaire which measures how the partner feels her sexual relationship with the patient has changed since his cancer diagnosis and therapy

Secondary Outcome Measures

1. Percentage of Patients With Freedom From Biochemical Failure [2 years after treatment]

   Patients without documented failure will undergo needle biopsy of the prostate. A minimum of 12 core biopsies will be taken and additional biopsies will be taken from any suspicious areas (ultrasound or palpation) and/or the original site of biopsy confirmation of prostate cancer at diagnosis. The 12 biopsy sites include sextant, bilateral lateral base, bilateral lateral mid-gland and bilateral transition zone. These data will enable us to evaluate the extent of disease eradication, as well as the prognostic significance of positive biopsies in otherwise palpably normal prostate glands after treatment.

2. Acute GI Toxicity [5 years after treatment]

3. Acute GU Toxicity [5 years after treatment]

Eligibility Criteria

Criteria

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

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Clinical stage T1b-T2c by palpation

• Pretreatment prostate-specific antigen ≤ 20 ng/mL

• Gleason score ≤ 7

• Suitable erectile function, defined as a response ≥ score 2 in question #1 of the International Index of Erectile Function Questionnaire

• No clinical, radiographic, or pathologic evidence of nodal or distant metastatic disease

PATIENT CHARACTERISTICS:

Age

• Not specified

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Fertile patients must use effective contraception

• No other active malignancy within the past 5 years except nonmetastatic skin cancer or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma)

• No other medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Prior androgen-ablation therapy allowed provided total calculated duration ≤ 4 months

Radiotherapy

• No prior pelvic radiotherapy

Surgery

• No prior or planned radical prostate surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497

Sponsors and Collaborators

• Fox Chase Cancer Center

Investigators

• Principal Investigator: Eric Horwitz, MD, Fox Chase Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fox Chase Cancer Center
• ClinicalTrials.gov Identifier: NCT00084552
• Other Study ID Numbers: 03-028; CDR0000365458
• First Posted: Jun 11, 2004
• Last Update Posted: Feb 25, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Fox Chase Cancer Center: sexual dysfunction; sexuality and reproductive issues; adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Standard IMRT (S-IMRT)	Erectile Tissue Sparing IMRT (ETS-IMRT)
Arm/Group Description	Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks. radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.	Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks. radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
Period Title: Overall Study
STARTED	54	62
COMPLETED	54	62
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	s-IMRT	ETS-IMRT	Total
Arm/Group Description	Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks. radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.	Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks. radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.	Total of all reporting groups
Overall Participants	54	62	116
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	61	62	62
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	54 100%	62 100%	116 100%
Race/Ethnicity, Customized (Count of Participants)
White	44 81.5%	51 82.3%	95 81.9%
Black	10 18.5%	10 16.1%	20 17.2%
Hispanic	0 0%	1 1.6%	1 0.9%
Region of Enrollment (participants) [Number]
United States	54 100%	62 100%	116 100%

Outcome Measures

1. Primary Outcome

Title	Erectile Dysfunction Rates
Description	Postage Stamp Test -A row of stamps is placed around the base of the penis and the ends are moistened and joined. If the circle is broken in the morning then the subject was recorded as having had a nocturnal erection International Index of Erectile Function (IIEF) Questionnaire 15-item questionnaire that measures erectile function Includes companion questionnaire which measures how the partner feels her sexual relationship with the patient has changed since his cancer diagnosis and therapy
Time Frame	5 year duration after completion of radiotherapy

Outcome Measure Data

Analysis Population Description

Some patients did not submit follow-up questionnaires at 24 months post-treatment

Arm/Group Title	s-IMRT	ETS-IMRT
Arm/Group Description	Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks. radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.	Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks. radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
Measure Participants	37	48
Count of Participants [Participants]	27 50%	36 58.1%

2. Secondary Outcome

Title	Percentage of Patients With Freedom From Biochemical Failure
Description	Patients without documented failure will undergo needle biopsy of the prostate. A minimum of 12 core biopsies will be taken and additional biopsies will be taken from any suspicious areas (ultrasound or palpation) and/or the original site of biopsy confirmation of prostate cancer at diagnosis. The 12 biopsy sites include sextant, bilateral lateral base, bilateral lateral mid-gland and bilateral transition zone. These data will enable us to evaluate the extent of disease eradication, as well as the prognostic significance of positive biopsies in otherwise palpably normal prostate glands after treatment.
Time Frame	2 years after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	s-IMRT	ETS-IMRT
Arm/Group Description	Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks. radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.	Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks. radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
Measure Participants	54	62
Number [percentage of participants]	90.7 168%	91.8 148.1%

3. Secondary Outcome

Title	Acute GI Toxicity
Time Frame	5 years after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	s-IMRT	ETS-IMRT
Arm/Group Description	Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks. radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.	Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks. radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
Measure Participants	54	62
Count of Participants [Participants]	1 1.9%	6 9.7%

4. Secondary Outcome

Title	Acute GU Toxicity
Time Frame	5 years after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	s-IMRT	ETS-IMRT
Arm/Group Description	Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks. radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.	Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks. radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
Measure Participants	54	62
Count of Participants [Participants]	20 37%	27 43.5%

Adverse Events

Time Frame	5 years
Arm/Group Title	s-IMRT		ETS-IMRT
Arm/Group Description	Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks. radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.		Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks. radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
All Cause Mortality
	s-IMRT		ETS-IMRT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/62 (0%)
Serious Adverse Events
	s-IMRT		ETS-IMRT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/62 (0%)
Other (Not Including Serious) Adverse Events
	s-IMRT		ETS-IMRT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/62 (0%)

Limitations/Caveats

The magnitude of the effect of erectile sparing constraints may be decreased for patients who experience dose-limiting parameters in the s-IMRT arm. Some patients did not complete follow-up, and to submit follow-up questionnaires at 24 months post-treatment.

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.