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
Description
This randomized phase III trial is comparing the effects, good and/or bad of three treatment methods on participants and their cancer.
Primary:
The primary study objectives are to determine if the following improve disease outcomes in men with prostate cancer who will be receiving radiation treatment to the prostate bed because they have a rising PSA level following a radical prostatectomy:
• addition of hormonal therapy to radiation treatment of
the prostate bed
• addition of radiation treatment of the pelvic lymph
nodes AND hormonal therapy to radiation treatment of
the prostate bed
Secondary; The secondary study objectives include comparisons of quality of life, toxicity, cost-effectiveness, and future biological correlative studies among the different treatment groups.
Study/Treatment
Prostate Cancer
Inclusion/Notes
Inclusion
Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to by 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;
Age = 18
Male
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 extent of the pelvic lymph node dissection (obturator vs. extended lymph node dissection) should be noted.
A post-radical prostatectomy entry PSA of greater than or equal to 0.2 and less than 2.0 ng/mL at least 6 weeks after prostatectomy and within 30 days of registration;
One of the following pathologic classificiations:
T3N0/Nx disease; or T2N0/Nx disease with positive prostatectomy margin and/or positive prostatic fossa or urethral-vesical anastomosis biopsies;
Prostatectomy Gleason score of 8 or less;
PSA Doubling Time (PSADT) of > 6 months prior to registration; PSA Doubling Times (PSADT) should be calculated via the Calculation of PSA Doubling Time page on the RTOG web site http://www.rtog.org/psadt.html. Review the instructions for calculating the PSADT located at the top of this page, and then select "Retrieve PSADT value" at the bottom center of the page;
Zubrod Performance Status of 0-1;
A digital rectal exam within 30 days prior to registration
No distant metastases, based upon the following minimum diagnostic workup:
History/physical examination within 8 weeks prior to registration;
A CT scan (with contrast if renal function is acceptable) or MRI of the abdomen and pelvis within 90 days prior to registration;
Bone scan within 90 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 = 12.0 g/dl based upon CBC (Note: The use of transfusion or other intervention to achieve Hgb = 12.0 g/dl is acceptable).
AST or ALT < 2 x the upper limit of normal within 90 days prior to registration;
Serum total testosterone within 90 days prior to registration;
Patients must sign a study-specific informed consent prior to study entry.
Exclusion
A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;
N1 patients are ineligible, as are those with pelvic lymph node enlargement greater than or equal to 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 greater than 6 months duration;
Androgen deprivation therapy started after prostatectomy and prior to registration;
Prior pelvic radiotherapy;
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the oral cavity is permissible);
PSA doubling time less than or equal to 6 months;
Severe, active co-morbidity, defined as follows:
History of inflammatory bowel disease;
History of hepatitis B or C. Blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of it.
Unstable angina and/or congestive heart failure requiring hospitalization with the last 6 months;
Transmural myocardial infarction within the last 6 months;
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; AST or ALT are required (see Section 3.1.11); note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol.
Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; Note however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may result in increased toxicity and immunosuppression.
Prior allergic reaction to the study drug(s) involved in this protocol.
Start Date
07/18/2011
Principal Name
John A Pablo, MD
Current Trial Type
Cancer
Phone
(912) 819-5704
Nancy N. and J.C. Lewis Cancer & Research Pavilion225 Candler Drive, Savannah, Georgia 31405
