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


Phase 2
N/A
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Michael J. Zelefsky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

97-064

NCT ID:

NCT00003104

Start Date:

June 1997

Completion Date:

October 2005

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Adenocarcinoma
  • Prostatic Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021