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Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer

A Phase II Study Using High Dose Three Dimensional Conformal Radiation Therapy in Intermediate Prognostic Risk Patients With Adenocarcinoma of the Prostate

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00003104
Enrollment
50
Registered
2003-01-27
Start date
1997-06-30
Completion date
2005-10-31
Last updated
2013-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer

Brief summary

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.

Detailed description

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.

Interventions

RADIATIONradiation therapy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion 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 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026