Intensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer
- Conditions
- Sexuality and Reproductive IssuesSexual DysfunctionProstate Cancer
- Interventions
- Radiation: radiation therapy
- Registration Number
- NCT00084552
- Lead Sponsor
- Fox Chase Cancer Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 116
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II radiation therapy Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks. Arm I radiation therapy Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Acute GU Toxicity 5 years after treatment Acute GI Toxicity 5 years after treatment 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.
Trial Locations
- Locations (1)
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States