Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Not specified	NCI	MSKCC-97064 NCI-H97-0006, NCT00003104

Objectives

1. Establish the efficacy of high-dose three-dimensional conformal radiotherapy in patients with intermediate prognostic risk adenocarcinoma of the prostate.
2. 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

A 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 Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Michael Zelefsky, MD, Protocol chair		Ph: 212-639-6802; 800-525-2225

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
Registered in ClinicalTrials.gov		NCT00003104
Date Submitted to PDQ		1997-10-08
Information Last Verified		2005-04-06
NCI Grant/Contract Number		CA59017, CA08748

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