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Tracking Information | |||||
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First Received Date † | September 13, 2005 | ||||
Last Updated Date | March 10, 2008 | ||||
Start Date † | June 2005 | ||||
Current Primary Outcome Measures † |
Primary endpoint will be the proportion of patients remaining progression-free [ Time Frame: 18 months from the time patient receives the MDX-010. ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00170157 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Monitor the initial PSA response which encompasses absolute nadir value, time-until-nadir, and greatest percent decline in PSA (at nadir) [ Time Frame: Duration of study ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | MDX-010 for Advanced Prostate Cancer | ||||
Official Title † | A Phase II Immunotherapeutic Trial: Combination Androgen Ablative Therapy and CTLA-4 Blockade as a Treatment for Advanced Prostate Cancer | ||||
Brief Summary | A total of 108 males with advanced prostate cancer will be enrolled into this study. Patients must have undergone prostate cancer staging within 180 days of enrollment. 54 patients will be randomized to receive hormone therapy alone and 54 patients will be randomized to receive hormone therapy plus the MDX-010 therapy. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study | ||||
Condition † | Prostatic Neoplasms | ||||
Intervention † | Drug: Combination Androgen Ablative Therapy | ||||
Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 108 | ||||
Completion Date | |||||
Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Males 18 years of age or older with histologically confirmed adenocarcinoma of the prostate staged within 180 days of study enrollment, any T stage, with or without metastases, with an initial PSA of ≥4.0 ng/ml may be eligible for enrollment into this protocol. Participants may not have underwent prior systemic chemotherapy or prior radiation therapy to the prostate. Includes post radical prostatectomy patients with a rising PSA and patients who have started hormone therapy ≤21 days |
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Gender | Male | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00170157 | ||||
Responsible Party | Eugene Dai Kwon, M.D., Mayo Clinic | ||||
Secondary IDs †† | DAMD17-02-1-0245 | ||||
Study Sponsor † | Mayo Clinic | ||||
Collaborators †† |
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Investigators † |
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Information Provided By | Mayo Clinic | ||||
Verification Date | March 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |