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Metformin Hydrochloride and Aspirin in Treating Patients With Hormone-Dependent Prostate Cancer That Has Progressed After Surgery or Radiation Therapy

NCT02420652 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-02-08

Study results available
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Summary

This randomized phase II trial studies how well metformin hydrochloride and aspirin work in treating patients with hormone-dependent prostate cancer that has progressed after surgery or radiation therapy. Metformin hydrochloride and aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving metformin hydrochloride and aspirin together can slow the growth of prostate cancer.

Conditions

  • Recurrent Prostate Carcinoma
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer

Interventions

DRUG

Aspirin

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Metformin Hydrochloride

Given PO

OTHER

Placebo

Given metformin hydrochloride placebo PO

OTHER

Placebo

Given aspirin placebo PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Rutgers Cancer Institute of New Jersey

    collaborator OTHER

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Biren Saraiya, MD · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-23
Primary Completion
2019-12-01
Completion
2019-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02420652 on ClinicalTrials.gov