RTOG 534 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

Summary

Subjects for this study will be enrolled by the Moncrief Radiation Oncology Department at the Simmons Cancer Center. Intensity Modulated RT (IMRT) is allowed for this study.

Arm 1: Prostate bed radiotherapy alone: PBRT 64.8-70.2 Gy (1.8 Gy per fraction). Radiotherapy will
start within 42 days (+/-14 days) after registration.

Arm 2: Prostate bed radiotherapy 60 days (+/-14 days) after starting neoadjuvant and concurrent short-term androgen deprivation: PBRT 64.8-70.2 Gy (1.8 Gy per fraction) + neoadjuvant and concurrent short-term androgen deprivation for 120-180 days

Arm 3, Pelvic lymph node + prostate bed radiotherapy 60 days (+/-14 days) after starting neoadjuvant and concurrent short-term androgen deprivation: PLNRT to 45 Gy (1.8 Gy per fraction) and PBRT to 64.8-70.2 Gy
(1.8 Gy per fraction) + neoadjuvant and concurrent short-term androgen deprivation for 120-180 days,

Short term androgen deprivation will begin from the start of luteinizing hormone releasing hormone agonist injection within 6 weeks after registration, and will consist of total androgen deprivation, using a combination of antiandrogen and luteinizing hormone releasing hormone agonist therapy for a total of 4-6 months. The antiandrogen will be either flutamide at 250 mg p.o. TID or bicalutamide at 50 mg p.o. QD. Antiandrogen therapy should begin at approximately the same time as LHRH agonist injection but may be started up to two weeks earlier. LHRH agonist injection will consist of analogs approved by the FDA (or by Health Canada for Canadian institutions), e.g., leuprolide, goserelin, buserelin, or triptorelin and may be given in any possible combination.

The RTOG Required Sample Size is 1764. A total of 22 patients will be required to complete the study locally. The maximum number of patients to be consented is 18, allowing for screen failures and early withdrawls. The expected time to completion of enrollment is 24 months.

Participant 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;
--Any type of radical prostatectomy will be permitted, including retropubic, perineal,
laparoscopic or robotically assisted. If performed, the number of lymph nodes removed per
side of the pelvis and the extent of the pelvic lymph node dissection (obturator vs. extended
lymph node dissection) should be noted. There is no time limit for the date of radical
prostatectomy.
--A post-radical prostatectomy entry 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:
T3N0/Nx disease with or without a positive prostatectomy surgical margin; or
T2N0/Nx disease with or without a positive prostatectomy surgical margin;
--Prostatectomy Gleason score of 8 or less;
--Zubrod Performance Status of 0-1;
--Age ≥ 18;
--No distant metastases, based upon the following minimum diagnostic workup:
--History/physical examination (including digital rectal exam) within 8 weeks (60Days) prior to
registration;
--A CT scan of the pelvis (with contrast if renal function is acceptable) or MRI of the abdomen and pelvisa noncontrast CT is permitted if the patient is not a candidate for contrast) within 120 days prior to registration;
--Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray
and/or MRI must be obtained to rule out metastasis.
--Adequate bone marrow function, within 90 days prior to registration, defined as follows:
􀂃 Platelets ≥ 100,000 cells/mm3 based upon CBC;
􀂃 Hemoglobin ≥ 10.0 g/dl based upon CBC (Note: The use of transfusion or other
intervention to achieve Hgb ≥ 10.0 g/dl is recommended).
--AST or ALT < 2 x the upper limit of normal within 90 days prior to registration;
--Serum total testosterone must be ≥ 40% of the lower limit of normal (LLN) of the assay used
(testosterone ÷ LLN must be ≥ 0.40) within 90 days prior to registration (Note: Patients who
have had a unilateral orchiectomy are eligible as long as this requirement is met);
--Patients must sign a study-specific informed consent prior to study entry.