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OpenTrials
Completed

NCT Number: NCT00003104

Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer

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.

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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2005
Study completion
2005
First posted
Jan 27, 2003
Registry last updated
Jun 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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