A Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy (0622)

Inclusion Criteria:

Pathologically (histologically) proven diagnosis of prostate cancer progressing after radical prostatectomy as indictated by one of the following:

• Postoperative PSA rising above 2.0ng/ml; or
• Postoperative PSA rising above 0.2 ng/ml with a surgical tumor Gleason score of 9 or 10; or
• Rapidly rising PSA profile with a doubling time less than 6 months.
• PSA Doubling Time (PSADT) should be calculated via the Calculation of PSA Doubling Time page on the RTOG web site http://www.rtog.org/psadt.html
• Pathologic stage T2 - T4 N0 - N1, including no distant metastases, based upon the following minimum diagnostic workup:
• History/physical examination within 8 weeks prior to registration
• Bone scan negative for bone metastases within 4 months prior to registration
• Abdominal imaging negative for metastases within 6 mothns prior to registration
• Zubrod Performance Status 0-1
• Age greater than or equal to 18 years.
• CBC/differential and PSA obtained within 4 weeks prior to registration, with adequate bone marrow function defined as follows:
• Absolute Neutrophil Count (ANC) greater than or equal to 1,800 cells/mm³
• Platelets greater than or equal to 100,000 cells/mm³
• Hemoglobin (Hgb) greater than or equal to 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb greater than or equal to 8.0 g/dl is permitted)
• Patients must be able to provide study specific informed consent prior to study entry.

Exclusion Criteria:

• Biopsy evidence of M1 disease
• Presence of neuroendocrine features in any prostate cancer specimen
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
• Prior systemic chemotherapy for the study cancer (Note: Prior chemotherapy for a different cancer is permitted.)
• Hormonal therapy initiated within the last 3 months
• Prior radiotherapy to the pelvic region that would result in overlap of radiation therapy fields
• Severe, active co-morbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within 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
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (Note: Laboratory tests for liver function and coagulation parameters, however, are not required for entry into this protocol.)
• Renal failure (Note: Laboratory tests for renal function, however, are not required for entry into this protocol.)
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition (Note: HIV testing is not required). The need to exclude patients with AIDS is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.