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Sponsored by: |
Protox Therapeutics |
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Information provided by: | Protox Therapeutics |
ClinicalTrials.gov Identifier: | NCT00379561 |
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 |
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Prostate Cancer |
Drug: PSA-Activated PSA-PAH1 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety Study |
Official Title: | A Phase 1 Trial of PSA-Activated PSA-PAH1 Therapy for Locally Recurrent Prostate Cancer Without Metastases After Primary Radiation Therapy |
Estimated Enrollment: | 36 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | May 2008 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
For more information please contact Primary Investigator or Protox Therapeutics, Inc.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Within one year prior to enrollment:
Within 3 months prior to enrollment:
Within 30 days prior to enrollment:
Exclusion Criteria:
United States, Texas | |
Cancer Research Institute of Scott and White | |
Temple, Texas, United States, 76502 |
Principal Investigator: | King S Coffield, M.D. | Cancer Research Institute of Scott and White |
Responsible Party: | Protox Therapeutics Inc. ( Rosemina Merchant, Vice-President Development and Regulatory Affairs ) |
Study ID Numbers: | PRX302 |
Study First Received: | September 20, 2006 |
Last Updated: | February 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00379561 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Prostate Cancer Recurrent Prostate Cancer Non-Metastatic prostate cancer Recurrent Localized Prostate Cancer with Biochemical Failure |
Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |