Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer

This study has been completed.
Information provided by:
Memorial Sloan-Kettering Cancer Center Identifier:
First received: November 1, 1999
Last updated: June 24, 2013
Last verified: June 2013

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

Resource links provided by NLM:

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Estimated Enrollment: 50
Study Start Date: June 1997
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No major medical illness
  • No psychosis
  • No metallic pelvic prosthesis


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • Prior neoadjuvant antiandrogen therapy allowed


  • No prior radiotherapy
  • No prior pelvic irradiation


  • No prior radical surgery for carcinoma of the prostate
  Contacts and Locations
Please refer to this study by its identifier: NCT00003104

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Study Chair: Michael J. Zelefsky, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided Identifier: NCT00003104     History of Changes
Other Study ID Numbers: 97-064, CDR0000065838, NCI-H97-0006
Study First Received: November 1, 1999
Last Updated: June 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on April 17, 2014