PSA-Activated PSA-PAH1 for Locally Recurrent Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Sophiris Bio Corp
ClinicalTrials.gov Identifier:
NCT00379561
First received: September 20, 2006
Last updated: October 27, 2009
Last verified: September 2009
  Purpose

This Phase 1 trial will evaluate the safety and tolerability of PSA-Activated PSA-PAH1 in subjects who have shown biochemical failure and have either completed at least one primary radiation therapy for prostate cancer and have evidence of recurrent local prostate cancer without metastases.


Condition Intervention Phase
Prostate Cancer
Drug: PSA-Activated PSA-PAH1
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of PSA-Activated PSA-PAH1 Therapy for Locally Recurrent Prostate Cancer Without Metastases After Primary Radiation Therapy

Resource links provided by NLM:


Further study details as provided by Sophiris Bio Corp:

Primary Outcome Measures:
  • Safety and Tolerance of PSA-PAH1
  • MTD of PSA-PAH1

Secondary Outcome Measures:
  • Pharmacokinetic data on PSA-PAH1
  • Immune response to PSA-PAH1
  • Evidence of activity of PSA-PAH1

Estimated Enrollment: 36
Study Start Date: March 2006
Study Completion Date: July 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379561

Locations
United States, Texas
Cancer Research Institute of Scott and White
Temple, Texas, United States, 76502
Sponsors and Collaborators
Sophiris Bio Corp
Investigators
Principal Investigator: King S Coffield, M.D. Cancer Research Institute of Scott and White
  More Information

Additional Information:
PRX302  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Rosemina Merchant, Vice-President Development and Regulatory Affairs, Protox Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00379561     History of Changes
Other Study ID Numbers: PRX302
Study First Received: September 20, 2006
Last Updated: October 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sophiris Bio Corp:
Prostate Cancer
Recurrent Prostate Cancer
Non-Metastatic prostate cancer
Recurrent Localized Prostate Cancer with Biochemical Failure

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 21, 2014