Metformin Hydrochloride and Aspirin in Treating Patients With Hormone-Dependent Prostate Cancer That Has Progressed After Surgery or Radiation Therapy (PRIMA)
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|ClinicalTrials.gov Identifier: NCT02420652|
Recruitment Status : Active, not recruiting
First Posted : April 20, 2015
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Prostate Carcinoma Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer||Drug: Aspirin Other: Laboratory Biomarker Analysis Drug: Metformin Hydrochloride Other: Placebo||Phase 2|
I. To determine the effect of metformin (metformin hydrochloride) and aspirin on the change in prostate-specific antigen (PSA) progression in men with rising PSA after definitive therapy for localized prostate cancer and stable disease during a run-in period with the study regimen.
I. To determine the feasibility and safety of administering metformin and aspirin.
II. To determine the effect of metformin and aspirin on PSA levels and the serum obesity-related prostate cancer (PCa) biomarkers (insulin, insulin-like growth factor [IGF]-1, interleukin [IL]-1beta, IL-6, and tumor necrosis factor [TNF]-alpha).
RUN-IN STAGE: Patients receive metformin hydrochloride orally (PO) twice daily (BID) and aspirin PO once daily (QD) for 4 months. Patients with disease progression (PSA increase of > 50% and minimum of 2ng/ml rise in PSA) come off study. Patients achieving disease response (>25% decline in PSA) continue to receive study agents in the absence of disease progression or unacceptable disease. Patients with stable disease continue on to the randomized study regimen.
RANDOMIZATION STAGE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive metformin hydrochloride PO BID and aspirin PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive metformin hydrochloride placebo PO BID and aspirin placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12-16 weeks for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2 Randomized Discontinuation Trial in Patients With Hormone-Dependent Rising Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer Evaluating the Synergy of Metformin Plus Aspirin (PRIMA Trial)|
|Actual Study Start Date :||June 23, 2015|
|Estimated Primary Completion Date :||January 8, 2022|
|Estimated Study Completion Date :||January 1, 2024|
Experimental: Arm I (metformin hydrochloride, aspirin)
Patients receive metformin hydrochloride PO BID and aspirin PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Drug: Metformin Hydrochloride
Placebo Comparator: Arm II (metformin hydrochloride placebo, aspirin placebo)
Patients receive metformin hydrochloride placebo PO BID and aspirin placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Given metformin hydrochloride placebo PO
Given aspirin placebo PO
- Change in stable PSA rates after 6 months of metformin hydrochloride and aspirin or placebo therapy in patients who have received 4 months of open label treatment [ Time Frame: Baseline to up to 6 months ]
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): NCT02420652
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Biren Saraiya, MD||Rutgers Cancer Institute of New Jersey|