Intensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer Sexual Dysfunction Sexuality and Reproductive Issues |
Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 |
- Erectile dysfunction rates as measured by IIEF after treatment [ Time Frame: 6 month intervals after completion of radiotherapy for 5 years ] [ Designated as safety issue: No ]
- Freedom from biochemical failure [ Designated as safety issue: No ]
- Local control [ Designated as safety issue: No ]
- Freedom from distant metastasis [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | December 2003 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Genders 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| United States, Pennsylvania | |
| Fox Chase Cancer Center - Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Contact: Eric Horwitz, MD 215-728-3540 | |
| Principal Investigator: | Eric Horwitz, MD | Fox Chase Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Fox Chase Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00084552 History of Changes |
| Other Study ID Numbers: | CDR0000365458, FCCC-03028 |
| Study First Received: | June 10, 2004 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 Sexual Dysfunctions, Psychological Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases Sexual and Gender Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013