Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Completed | Not specified | NCI | MSKCC-97064 NCI-H97-0006, NCT00003104 |
Objectives
- Establish the efficacy of high-dose three-dimensional conformal radiotherapy in patients with intermediate prognostic risk adenocarcinoma of the prostate.
- Determine the PSA relapse-free survival rate of this patient population.
Entry Criteria
Disease Characteristics:
- Histologically proven intermediate prognostic risk (T1-T2) adenocarcinoma of the prostate
- Previously untreated (except for hormonal therapy)
- PSA levels greater than 10 ng/mL and Gleason scores no
greater than 6
OR
- PSA levels no greater than 10 ng/mL and Gleason scores at least 7
- Patients requiring volume reduction of prostate prior to radiotherapy continue to be treated at least 3 months on neoadjuvant hormonal therapy prior to radiation
- No evidence of distant metastases
- No regional lymph node involvement
Prior/Concurrent Therapy:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- See Disease Characteristics
- Prior neoadjuvant antiandrogen therapy allowed
Radiotherapy:
- No prior radiotherapy
- No prior pelvic irradiation
Surgery:
- No prior radical surgery for carcinoma of the prostate
Patient Characteristics:
Age:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No major medical illness
- No psychosis
- No metallic pelvic prosthesis
Expected Enrollment
50A total of 50 patients will be accrued for this study.
Outline
Patients receive high-dose three-dimensional conformal radiotherapy 4-5 days per week for at least 9 weeks.
Patients are evaluated at least weekly during radiotherapy and at 2 and 4 months after treatment completion. Thereafter, patients are followed every 6 months for a total of 3 years.
Trial Lead Organizations
Memorial Sloan-Kettering Cancer Center
 | | | |
| Michael Zelefsky, MD, Protocol chair | |
| |
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| Registry Information | ||
| ||
| Official Title | A Phase II Study Using High Dose Three Dimensional Conformal Radiation Therapy in Intermediate Prognostic Risk Patients with Adenocarcinoma of the Prostate | |
| ||
| Trial Start Date | 1997-06-10 | |
| ||
| Trial Completion Date | 2005-10-11 | |
| ||
| Registered in ClinicalTrials.gov | NCT00003104 | |
| ||
| Date Submitted to PDQ | 1997-10-08 | |
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| Information Last Verified | 2009-12-11 | |
| ||
| NCI Grant/Contract Number | CA59017, CA08748 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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