Patient selection and eligibility criteria
ventricular arrhythmia, respiratory illness, malignancy, cancer, non-melanoma skin cancer, impaired immunity, prostate, COPD, viral infections, active co-morbidity, hepatitis, prostate cancer
ACUTE INFECTION, RECURRENCE, METASTASIS, VENTRICULAR ARRHYTHMIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CANCER, DISEASE, VIRAL INFECTION, METASTATIC DISEASE, PROSTATE, COPD, HEPATITIS, CONGESTIVE HEART FAILURE, HEART, DISEASES, PROSTATE CANCER
Patients were required to have biopsy proven local recurrence of prostate cancer at least one year after the completion of definitive radiation therapy. The biopsy must have been performed within 180 days of study registration. Serum PSA < 100 ng/ or evidence of biologically active disease as demonstrated by an unequivocally rising serum PSA level that is ≥ 2 ng/mL above the nadir. Subjects were eligible if at least 18 years old with Karnofsky performance status ≥70. Patients were required to have negative lymph nodes as established by imaging (pelvic CT or pelvic MRI) within 90 days of registration. Men with lymph nodes equivocal or questionable by imaging were eligible if the nodes were ≤ 1.0 cm. Men with positive lymph nodes by capromab pendetide (ProstaScint) scans were eligible provided a corresponding lymph node identified by CT or MR imaging was ≤ 1.0 cm. Patients were required to demonstrate no evidence of metastatic disease, as evaluated by a bone scan and CT scan of the abdomen and pelvis within 90 days prior to registration. Equivocal bone scan findings were allowed if plain films were negative for metastasis. Patients were required to have adequate baseline organ function, as assessed by the following laboratory values, before initiating the protocol, including: (i) adequate renal function with serum creatinine ≤1.5 mg/dl or creatinine clearance ≥50 ml/min/m2; (ii) platelet count >100,000/μL; (iii) absolute neutrophil count >1,000/μL; (iv) hemoglobin >10.0 g/dL; and (v) bilirubin <1.5 mg/dL, and serum glutamic oxaloacetic transaminase and serum glutamic pyruvic transaminase <3 times the upper limit of normal. Patients had to have the ability to give informed consent and express a willingness to meet all of the expected requirements of the protocol for the duration of the study.Patients with any one of the following conditions were excluded from the study: (i) PSA ≥ 100 ng/mL, (ii) prostate volume > 100 cc, (iii) pathologically positive lymph nodes or nodes > 1.0 cm on imaging (nodes > 1.0 cm but biopsy negative were allowed), (iv) evidence of M1 metastatic disease, (v) prior invasive malignancy except for non-melanoma skin cancer within 5 years of enrollment. Subjects were required to be disease-free for > 5 years, (vi) prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason, (vii) biochemical failure while on AST if the subject had prior AST, (viii) prior systemic chemotherapy for prostate cancer. Prior chemotherapy for a different cancer was allowed given patients were >2 years post-completion of chemotherapy at the time of registration. Subjects on Proscar therapy were required to stop Proscar therapy to be eligible, (ix) severe active co-morbidity such as New York Heart Association Class II or greater congestive heart failure or active ventricular arrhythmia requiring medication, Chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization within last 3 months or precluding study therapy at the time of registration, (x) acute infection, (xi) previous history of livery diseases including hepatitis, (xii) immunosuppressive therapy including systemic corticosteroids, and (xiii) impaired immunity or susceptibility to serious viral infections. All patients met the eligibility requirements of the protocol and signed the informed consent document. There were no protocol violations. All patients were recruited between October 2015 to March 2019.1.