A Phase III Trial of Short-Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed-Only Radiotherapy in Prostate Cancer Patients with a Rising PSA after Radical Prostatectomy

Protocol
09-102
Full Title
A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients with a Rising PSA After Radical Prostatectomy (RTOG 0534)
Purpose

The purpose of this study is to evaluate three different prostate cancer treatment regimens for men whose prostate was surgically removed but whose PSA level continues to rise:

  • radiation therapy to the prostate bed (the area where the prostate was located before it was removed)
  • hormone therapy for 4 to 6 months plus radiation therapy to the prostate bed
  • hormone therapy for 4 to 6 months plus radiation therapy to the prostate bed and to the pelvic lymph nodes.

There is some evidence in men who have not had surgery that radiotherapy to the pelvic lymph nodes may stop prostate cancer from spreading under some conditions. Since treating the pelvic lymph nodes can result in increased side effects, the benefit of this method of radiation therapy needs to be tested.

Some patients treated with hormonal therapy and radiation therapy have a reduced risk of recurrence compared to men treated with radiation alone.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have nonmetastatic prostate cancer and have had radical prostatectomy with evidence of a rising PSA (= 0.1 and < 2.0 ng/mL) after surgery.
  • Patients may not have had prior pelvic radiation therapy or androgen deprivation therapy.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Michael Zelefsky at 212-639-6802.

Disease(s)
Prostate Cancer
Prostate Cancer: Localized Disease
Prostate Cancer: Rising PSA After Primary Therapy
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