Status:
COMPLETED
Intensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer
Lead Sponsor:
Fox Chase Cancer Center
Conditions:
Prostate Cancer
Sexual Dysfunction
Eligibility:
MALE
18+ years
Phase:
NA
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) ma...
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 fo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 11 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2016
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00084552
Start Date
December 11 2003
End Date
May 5 2016
Last Update
February 25 2021
Active Locations (1)
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1
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497