N/A
Completed N=116
Intensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer
Prostate Cancer · Sexual Dysfunction · Sexuality and Reproductive Issues
Source: ClinicalTrials.gov NCT00084552 ↗
Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Erectile Dysfunction Rates — 27; 36 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Erectile Dysfunction Rates |
27; 36 | — |
| SECONDARY Percentage of Patients With Freedom From Biochemical Failure |
90.7; 91.8 | — |
| SECONDARY Acute GI Toxicity |
1; 6 | — |
| SECONDARY Acute GU Toxicity |
20; 27 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00084552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.