Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

PSA-Activated PSA-PAH1 for Locally Recurrent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379561
Recruitment Status : Completed
First Posted : September 22, 2006
Last Update Posted : October 29, 2018
Information provided by (Responsible Party):
Sophiris Bio Corp

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: PSA-Activated PSA-PAH1 Phase 1

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : March 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Intervention PSA-PAH1
Determination of the therapeutic activity of different concentrations of PSA-PAH1 at increasing doses of per gram of prostate.
Drug: PSA-Activated PSA-PAH1
Other Name: PRX302, Topsalysin

Primary Outcome Measures :
  1. Safety and Tolerance of PSA-PAH1
  2. MTD of PSA-PAH1

Secondary Outcome Measures :
  1. Pharmacokinetic data on PSA-PAH1
  2. Immune response to PSA-PAH1
  3. Evidence of activity of PSA-PAH1

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00379561

Layout table for location information
United States, Texas
Cancer Research Institute of Scott and White
Temple, Texas, United States, 76502
Sponsors and Collaborators
Sophiris Bio Corp
Layout table for investigator information
Principal Investigator: King S Coffield, M.D. Cancer Research Institute of Scott and White
Layout table for additonal information
Responsible Party: Sophiris Bio Corp Identifier: NCT00379561    
Other Study ID Numbers: PRX302
First Posted: September 22, 2006    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases