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

NCT02420652 | Terminated Phase 2 Results

• 4 other identifiers: 081501NCI-2015-00397Pro20150001378P30CA072720
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Measure of PSA ng/mL Rates After Six Months of Metformin Hydrochloride and Aspirin or Placebo Therapy in Patients Who Have Received Four Months of Open Label Treatment

  6 months

Study Arms (2)

Arm I (metformin hydrochloride, aspirin)

EXPERIMENTAL

Patients receive metformin hydrochloride PO BID and aspirin PO QD for 6 months in the absence of disease progression or unacceptable toxicity.

Drug: Aspirin; Other: Laboratory Biomarker Analysis; Drug: Metformin Hydrochloride

Arm II (metformin hydrochloride placebo, aspirin placebo)

PLACEBO COMPARATOR

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; Other: Placebo

Interventions

Aspirin DRUG

Given PO

Also known as: Acetylsalicylic Acid, ASA, Aspergum, Ecotrin, Empirin, Entericin, Extren, Measurin

Arm I (metformin hydrochloride, aspirin)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (metformin hydrochloride, aspirin); Arm II (metformin hydrochloride placebo, aspirin placebo)

Metformin Hydrochloride DRUG

Given PO

Also known as: Glucophage, Metformin HCl

Arm I (metformin hydrochloride, aspirin)

Placebo OTHER

Given metformin hydrochloride placebo PO

Also known as: placebo therapy, PLCB, sham therapy

Arm II (metformin hydrochloride placebo, aspirin placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically proven prostate cancer treated with surgery, radiation, or the combination of surgery and radiation for prostate cancer (metastatic to regional lymph nodes) with resection of the nodes, who now has a rising PSA value after definitive local therapy, and no visible metastatic disease on conventional imaging studies
• Patients must have undergone local treatment via prostatectomy or radiation therapy
• Patients must have PSA progression after local treatment:
• PSA values for patients after surgery (or surgery and salvage/adjuvant radiation) must be greater than or equal to 0.2 ng/mL, determined by two measurements, at least 1 month apart and at least 6 months after prostatectomy
• PSA values for patients after radiation must be greater than or equal to 2.0 ng/ml greater than the nadir achieved after radiation, determined by two measurements at 1 month apart and at least 6 months after the radiation treatment is completed; (patients who received adjuvant or salvage radiation after prostatectomy must have PSA of greater than or equal to 0.2)
• The first two PSA values, along with a third (study baseline) value must all be rising (i.e., there must be an overall rising trajectory, such that the third value cannot be lower than the first value)
• PSA must be less than 50 ng/mL at study entry
• PSA doubling time using the mkscc.org PSA doubling time calculator must be greater than 4 months
• Baseline bone scan, chest x-ray and computed tomography (CT)/magnetic resonance imaging (MRI) of abdomen/pelvis demonstrating no metastatic disease
• Estimated life expectancy of at least 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• White blood cells (WBC) \> 3500/ul
• Absolute neutrophil count (ANC) \> 1500/ul
• Hemoglobin \> 10 g/dl
• Platelet count \> 100,000/ul

You may not qualify if:

• Serious concomitant systemic disorder that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
• Patients may have received prior androgen deprivation therapy (ADT) in the neoadjuvant, adjuvant and/or salvage setting, but must be off therapy for at least 3 months and have a testosterone level \> 150 ng/dl
• Second primary malignancy except most situ carcinoma (e.g. adequately treated non-melanomatous carcinoma of the skin) or other malignancy treated at least 2 years previously with no evidence of recurrence
• Patients with type II diabetes currently already on metformin
• Patients taking aspirin for previously diagnosed cardiovascular disease
• Patients who received aspirin or metformin within the past 28 days
• Patients taking medications with known interactions with metformin or aspirin
• Patients taking warfarin or platelet inhibitors
• Patients requiring chronic use of nonsteroidal anti-inflammatory drugs (NSAIDS)
• Other concurrent experimental or investigational drugs
• Prior history of lactic acidosis or metabolic acidosis
• Patients with history of gastrointestinal (GI) bleeding and peptic ulcer disease
• Any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Aspirin; Metformin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Biguanides; Guanidines; Amidines

Limitations and Caveats

Early termination lead to a small number of study participants being analyzed.

Results Point of Contact

• Title: Biren Saraiya, MD
• Organization: Rutgers Cancer Institute of New Jersey

saraiybi@cinj.rutgers.edu

732-235-3360

Study Officials

• Biren Saraiya, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 20, 2015
• Study Start: June 23, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 8, 2023
• Results First Posted: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)