Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy.
PURPOSE: This phase II trial is studying how well radiation therapy that has been planned with a computer works in treating patients with prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Using High Dose Three Dimensional Conformal Radiation Therapy in Intermediate Prognostic Risk Patients With Adenocarcinoma of the Prostate |
| Estimated Enrollment: | 50 |
| Study Start Date: | June 1997 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
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.
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.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
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
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Michael J. Zelefsky, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003104 History of Changes |
| Other Study ID Numbers: | CDR0000065838, MSKCC-97064, NCI-H97-0006 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the prostate stage IIB prostate cancer stage IIA prostate cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013