Clinical Drug Experience Knowledgebase

Criteria

Subjects must meet all of the following criteria to be enrolled in this study.

Male aged 18 years or older
Signed written informed consent and willingness to comply with protocol requirements
Histologic diagnosis of prostate cancer by validated history and/or biopsy of the prostate or of a metastatic lesion.

Evidence of metastatic disease as documented by an abnormal bone scan and CT scan or MRI plus:

Castration/anti androgen therapy naïve/sensitive:

Gleason Score ≥ 7 and PSA ≥ 2.0 ng/mL with history of prostatectomy or primary radiation therapy of the prostate gland and prior undetectable PSA or; PSA > 10.0 ng/mL if intact prostate, or
Gleason score ≤ 6 and PSA is ≥ 20 ng/mL, or
Gleason Score ≥ 8 and any doubling of PSA, or PSA > 0.5 ng/mL, or
Clinical Stage 3 and Gleason Score ≥ 8

If on anti androgen therapy, must have initiated therapy at least 4 weeks prior to treatment.

Castration/anti androgen therapy resistant:

Patients must have current or historical evidence of disease progression concomitant with surgical (orchiectomy) or medical castration (LHRH analogue); anti androgen withdrawal (4 weeks for flutamide and 6 weeks for nilutamide or bicalutamide) is necessary only for patients on anti androgens who have demonstrated a > 3 month duration of beneficial response to anti androgens; progression is demonstrated by any of the following:

I. PSA progression: 2 serial rising PSA determinations at least 14 days apart over the PSA nadir, with the last measurement ≥ 2 ng/mL

II. Progression of measurable disease, or progression of non measurable disease as defined by:

i. Soft tissue disease: The appearance of one or more new lesions, and/or unequivocal worsening of non measurable disease when compared to imaging studies acquired during castration therapy or against the precastration studies if there was no response, or ii. Bone disease: Appearance of two or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre castration studies if there was no response.

III. Increased uptake of pre existing lesions on bone scan does not constitute progression.

IV. Testosterone ≤ 50 ng/dL achieved via medical or surgical castration.

Male subjects who are fertile agree to use an acceptable form of birth control, defined as abstinence, barrier or other acceptable, effective contraceptive method throughout the study period. A second form of barrier birth control must be utilized if a subject's partner is using oral contraception until at least seven days after the last injection.
Karnofsky performance is ≥ 50

Adequate hematologic, renal and liver function:

WBC ≥ 2.0×103/mm3 (ANC > 1.0 x 103 mm3)
Platelet count ≥ 75×103/mm3
Hemoglobin ≥ 9.0 g/dL
Creatinine ≤ 2.5 mg/dL
Total bilirubin ≤ 2x ULN
AST, ALT ≤ 5x ULN

Exclusion Criteria:

Karnofsky performance status of < 50
Subject has received a permanent prostate brachytherapy implant within the last 3 months for 103Pd implants or 12 months for 125I implants
Subject was administered a diagnostic radioisotope within 5 physical half lives of that radioisotope prior to study enrollment
Subject has received an investigational compound and/or medical device or has been part of an investigational study within the past 30 days before enrollment into this study
Any treatment with radiopharmaceuticals, e.g. Strontium 89 and Samarium 153 within 6 months prior to enrollment
Ketoconazole or anti androgens (flutamide, nilutamide, bicalutamide) within 4 weeks prior to enrollment. Patients who demonstrate an antiandrogen withdrawal response, defined as a > 25% drop in PSA within 4 weeks (flutamide) or 6 weeks (nilutamide, bicalutamide) of stopping a non steroidal anti androgen, are not eligible until the PSA rises above the nadir observed after anti androgen withdrawal
Initiation of bisphosphonate therapy within 28 days prior to enrollment. Patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted in the interval between baseline scans and end of study
Subject has any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow up examinations
Subject is determined by the Investigator to be clinically unsuitable for the study
If the subject has had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, diagnosis and location must be defined or be defined as clinically controlled or treated to complete response