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.