Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer

Memorial Sloan Kettering Cancer Center (MSK) logo

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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