PSA-Activated PSA-PAH1 for Locally Recurrent Prostate Cancer

For more information please contact Primary Investigator or Protox Therapeutics, Inc.

Inclusion criteria

• 18 years of age or older
• Histologically proven prostate adenocarcinoma
• Completed a full course of definitive external beam radiation or definitive brachytherapy (but not both) as primary therapy for diagnosed prostate cancer at least one year prior to enrollment
• Subject must have at least one available PSA measurement that was taken 60 days or more following their primary therapy, but no later than 2 months prior to their screening visit (this measurement will serve as the first time point for computing a screening value for PSA doubling time)
• Subject's PSA doubling time at screening must be > 3 months (this doubling time will be computed by comparing the earliest available PSA that is 60 days or more following the subject's primary therapy but no later than 2 months prior to their screening visit, to the PSA measurement obtained during the screening visit)
• Within one year prior to enrollment:

• Demonstrated "biochemical failure," as determined by three consecutive increases in PSA at least 2 weeks apart
• Multiple-site biopsy-confirmed local recurrence of prostate cancer
• Within 3 months prior to enrollment:

• No evidence of metastatic disease including no bone metastases on bone scan, or any lymph node, lung, liver or soft tissue metastases on a CT or MRI scan or any other evidence of metastatic disease
• No receipt of androgen ablation therapy [Note: Subjects may have received androgen ablation therapy in the past, but not within 3 months prior to enrollment. No subject will be removed from androgen ablation therapy prior to this trial to permit/facilitate eligibility for this trial.]
• Within 30 days prior to enrollment:

• Prostate gland weighing less than 40 g estimated on the basis of CT/ultrasound data
• Serum testosterone above castrate range (> 1 ng/dL)
• PSA level less than 20 ng/mL
• Eastern Cooperative Oncology Group (ECOG) score of 0-2
• Written informed consent
• Adequate organ function as evidenced by:

Exclusion criteria

• Any history of active malignancy other than prostate cancer
• Have active viral, bacterial or fungal infections that require systemic therapy
• Prior biological, immunological or chemotherapy for prostate cancer
• Receiving concurrent medication for prostate cancer
• Received as primary therapy for prostate cancer, definitive external beam radiation and concomitant brachytherapy
• Prior history of metastatic prostate cancer
• Treatment with other investigational therapies within 12 months prior to enrollment that could produce a compromised immune system, or receipt of immunosuppressive drugs including corticosteroids or ketoconazole within 1 month prior to enrollment, or a history of immunodeficiency disease
• Recurrence of prostate cancer within 6 months after initiation of primary radiotherapy
• Active heart, liver, lung, renal disease, active infection or other serious uncontrolled illnesses
• Positive antibody test during screening for HIV-1, HIV-2, HTLV-1, HTLV-2, Hep B, or Hep C
• Unable or unwilling to return for required visits and follow-up examinations
• Have a chronic indwelling Foley catheter for obstructive uropathy
• Received salvage external beam radiotherapy and/or salvage seed brachytherapy prior to enrollment
• Received prior treatment with PSA-PAH1 (subjects may not be redosed under this protocol)
• Men unwilling to use condoms for the duration of the study (3 months) to prevent a pregnancy, and to avoid semen contact with their partner.