An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT00686088|
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : October 29, 2009
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|Condition or disease||Intervention/treatment||Phase|
|Locally Recurrent Prostate Cancer||Drug: PRX302||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
- Drug: PRX302
Determination of the therapeutic activity of different concentrations of PRX302 at increasing volumes and/or number of deposits per gram of prostate.
- PSA levels, PSA doubling time, PSA velocity and tumor burden assessment by biopsy compared to screening. [ Time Frame: Day 45 and Day 180 ]
- Safety and tolerability of PRX302. [ Time Frame: 12 months. ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- Completed a full course of radiation therapy for prostate cancer at least 2 years before enrollment.
- Biochemical failure at screening as determined by either the ASTRO or the Phoenix definitions.
- At least 5 available PSA readings after completion of radiation therapy and prior to screening.
- PSA level of not greater than 10 ng/mL.
- PSA doubling time of at least 9 months at screening.
- Biopsy-proven recurrent localized prostate cancer.
- Tumor stage T1C to T2C.
- Prostate volume estimated at 40 mL or less as determined by TRUS.
- ECOG performance score 0 to 2.
- Serum testosterone of at least 1 ng/dL.
- Prior history of metastatic prostate cancer.
- Salvage external beam therapy and/or salvage brachytherapy prior to enrollment.
- Biological, immunological, chemotherapeutic treatment or cryotherapy after completing radiation.
- Androgen ablation therapy within 12 months prior to enrollment.
- Recurrence of prostate cancer within 18 months of definitive primary radiotherapy.
- Other medication for prostate cancer.
- Presence of active malignancy other than prostate cancer.
- Treatment with other investigational therapies within 12 months prior to enrolment.
- Presence of a chronic indwelling Foley catheter for obstructive uropathy.
- Previous transurethral resection of the prostate (TURP), transurethral resection of the bladder neck, photo-selective vaporization of the prostate (PVP) or other resection surgery in the urinary tract.
- Previous treatment with PRX302.
- Any evidence of metastatic disease on bone scan, CT or magnetic resonance imaging (MRI) within 3 months prior to enrollment.
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 ClinicalTrials.gov identifier (NCT number): NCT00686088
|United States, Texas|
|Urology San Antonio|
|San Antonio, Texas, United States, 78229|
|Scott & White Memorial Hospital|
|Temple, Texas, United States, 76508|
|Responsible Party:||Rosemina Merchant, M.E.Sc., VP, Development and Regulatory Affairs, Protox Therapeutics|
|Other Study ID Numbers:||
|First Posted:||May 29, 2008 Key Record Dates|
|Last Update Posted:||October 29, 2009|
|Last Verified:||September 2009|
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