Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: radiation therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003104

97-064

CDR0000065838 (Registry Identifier)

NCI-H97-0006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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