Overview

This trial is active, not recruiting.

Conditions prostate cancer, sexual dysfunction, sexuality and reproductive issues
Treatment radiation therapy
Phase phase 3
Sponsor Fox Chase Cancer Center
Start date December 2003
End date October 2014
Trial size 200 participants
Trial identifier NCT00084552, CDR0000365458, FCCC-03028

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
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.
(Experimental)
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.

Primary Outcomes

Measure
Erectile dysfunction rates as measured by IIEF after treatment
time frame: 6 month intervals after completion of radiotherapy for 5 years

Secondary Outcomes

Measure
Freedom from biochemical failure
time frame:
Local control
time frame:
Freedom from distant metastasis
time frame:
Overall survival
time frame:

Eligibility Criteria

Male participants of any age.

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

Additional Information

Official title Outcomes Following Intensity Modulated Radiation Therapy With And Without Erectile Tissue Dose Sparing For Favorable To Intermediate Risk Prostate Cancer
Principal investigator Eric Horwitz, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Fox Chase Cancer Center.