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PSA-Activated PSA-PAH1 for Locally Recurrent Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

PSA-Activated PSA-PAH1 for Locally Recurrent Prostate Cancer

A Phase 1 Trial of PSA-Activated PSA-PAH1 Therapy for Locally Recurrent Prostate Cancer Without Metastases After Primary Radiation Therapy

NCT00379561•Sophiris Bio Corp

View on ClinicalTrials.gov

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.

Detailed Description

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

Eligibility

Age

18 - No limit years

Sex

MALE

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
+8 more criteria

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
+5 more criteria

Locations (1)

Cancer Research Institute of Scott and White

Temple, Texas, United States

Key Dates

Start Date

March 1, 2006

Primary Completion Date

May 1, 2007

Completion Date

July 1, 2008

Last Updated

October 29, 2018

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

PSA-Activated PSA-PAH1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PSA-Activated PSA-PAH1 for Locally Recurrent Prostate Cancer

Inclusion Criteria

Exclusion Criteria

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