Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radia… (NCT00567580) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer
United States1,792 participantsStarted 2008-02
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen-deprivation therapy is more effective for prostate cancer.
PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. 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 prostate-specific antigen (PSA) of ≥ 0.1 and \< 2.0 ng/mL at least 6 weeks (45 days) after prostatectomy and within 30 days of registration;
✓. One of the following pathologic classifications:
✓. Prostatectomy Gleason score of 9 or less;
✓. Zubrod Performance Status of 0-1;
✓. Age ≥ 18;
✓. No distant metastases, based upon the following minimum diagnostic workup:
✓. Adequate bone marrow function, within 90 days prior to registration, defined as follows:
Exclusion criteria
✕. A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;
What they're measuring
1
Percentage of Participants Free From Progression (FFP) at 5 Years
✕. N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥ 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is sampled and is negative;
✕. Androgen deprivation therapy started prior to prostatectomy for \> 6 months (180 days) duration. Note: The use of finasteride or dutasteride (±tamsulosin) for longer periods prior to prostatectomy is acceptable;
✕. Androgen deprivation therapy started after prostatectomy and prior to registration (Note: The use of finasteride or dutasteride (±tamsulosin) after prostatectomy is not acceptable - must be stopped within 3 months after prostatectomy. Androgen deprivation therapy must be stopped within 3 months after prostatectomy);
✕. Neoadjuvant chemotherapy before or after prostatectomy;
✕. Prior chemotherapy for any other disease site if given within 5 years prior to registration;
✕. Prior cryosurgery or brachytherapy of the prostate; prostatectomy should be the primary treatment and not a salvage procedure;