(RTOG 0534) 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

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Title (RTOG 0534) 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
Contact NeimanisD
Principal Investigator Michael Kuettel, MD, PhD, MBA
Study Number 126608
Phase3
Summary

The purpose of this study is to compare the effects that radiation therapy, hormone therapy or the combination of both have on participants with prostate cancer. There are 3 treatment groups (also referred to as arms) that the patient may be randomized (put into a group by chance) to in this study:

*Patients who receive radiation therapy to the prostate bed only;

*Patients who receive hormone therapy for 4 to 6 months plus radiation therapy to the prostate bed;

*Patients who receive hormone therapy for 4 to 6 months plus radiation therapy to the prostate bed and to the pelvic lymph nodes

Eligibility
  • Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx], i.e.lymph node dissection is not required
  • A post-radical prostatectomy entry PSA of greater than or equal to 0.1 but less than 2.0 ng/mL at least 6 weeks (45 days) after prostatectomy and within 30 days of registration
  • Must be 18 years of age or older
  • Prostatectomy Gleason score of 9 or less.
  • Neoadjuvant chemotherapy before or after prostatectomy; prior chemotherapy for any other disease site if given within 5 years prior to registration; and prior cryosurgery or brachytherapy make you ineligible for this study.
For more information about the clinical study go to Clinicaltrial.Gov