Impact of the Addition of Metformin to Abiraterone in Metastatic Prostate Cancer Patients

NCT01677897 | Completed Phase 2 DMC

• 1 other identifier: MetAb-Pro
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the impact of the addition of metformin to abiraterone on survival in patients with metastatic prostate cancer

Conditions

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• progression free survival

  at 12 weeks

Secondary Outcomes (1)

• overall survival

  up to 2 years

Other Outcomes (4)

• progression free survival at 24 weeks

  at 24 weeks

• progression free survival

  up to 24 weeks

• psa response

  at 12 weeks

Study Arms (1)

Metformin

EXPERIMENTAL

Metformin 2x1000mg orally per day

Drug: Metformin

Interventions

Metformin DRUG

Adding Metformin to Abiraterone in case of PSA-Progression

Also known as: Abiraterone

Metformin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic adenocarcinoma of the prostate.
• Patient must give written informed consent before registration.
• Age ≥18 years.
• WHO performance status 0-2.
• Tumor progression (as defined below) after at least 1 hormonal treatment (orchiectomy, LHRH agonist) with documented total testosterone levels ≤ 1.7 nmol/L (≤ 50 ng/dL). Ongoing concurrent use of LHRH agonist is required if the patient has not been surgically castrated.
• PSA progression during treatment with abiraterone (at least 12 weeks of treatment) defined as follows:
• In case PSA levels had not decreased under treatment: ≥ 25% increase over baseline (at registration) AND an increase in the absolute PSA value of ≥ 5 ng/mL.
• In case of PSA response \< 50% under treatment: ≥ 25% increase over the nadir AND an increase in the absolute PSA value of ≥ 5 ng/mL.
• In case of PSA response ≥ 50% under treatment: ≥ 50% increase over the nadir AND an increase in the absolute PSA value of ≥ 5 ng/mL Note: PSA progression has to be confirmed at least 1 week later. In case of confirmation the first date of PSA rise is relevant for the calculation.
• Serum potassium ≥ 3.5mmol/L.
• Adequate hematological values: neutrophils ≥1.5x109/L, platelets ≥100x109/L.
• Adequate hepatic function: bilirubin ≤1.5 x ULN, ALT ≤2.5 x ULN.
• Adequate renal function (calculated creatinine clearance ≥50 mL/min, according to the formula of Cockcroft-Gault).
• Able to swallow study drug as whole tablet.
• Patient compliance and geographic proximity allow proper staging and follow-up.

You may not qualify if:

• Previous malignancy within 2 years with the exception of localized non-melanoma skin cancer and Ta and Tis bladder cancer.
• Known CNS or spinal cord metastases.
• Active autoimmune disease requiring higher doses of corticosteroid than the equivalent of prednisone 10mg/d.
• Radiotherapy within the last 2 weeks before start of the trial treatment.
• Prior treatment with metformin Prior treatment with metformin
• Diabetic ketoacidosis, diabetic coma and precoma
• Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to trial entry, except treatment with bisphosphonates and LHRH agonists.
• Known hypersensitivity to trial drugs or hypersensitivity to any of their components.
• Concomitant drugs contraindicated for use with the trial drugs according to the Swissmedic-approved product information.
• Uncontrolled hypertension, history of cardiac failure NYHA class III or IV.
• Serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled or acute severe infection, uncontrolled diabetes).
• Active or symptomatic viral hepatitis or chronic liver disease.
• History of pituitary or adrenal dysfunction.
• Gastrointestinal disorder affecting absorption.
• Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, or interfering with compliance for oral drug intake.

Sponsors & Collaborators

• Kantonsspital Graubünden: lead
• Janssen-Cilag Ltd.: collaborator

Study Sites (1)

Kantonsspital Graubünden

Chur, Kanton Graubünden, 7000, Switzerland

Location

Related Publications (1)

• Mark M, Klingbiel D, Mey U, Winterhalder R, Rothermundt C, Gillessen S, von Moos R, Pollak M, Manetsch G, Strebel R, Cathomas R. Impact of Addition of Metformin to Abiraterone in Metastatic Castration-Resistant Prostate Cancer Patients With Disease Progressing While Receiving Abiraterone Treatment (MetAb-Pro): Phase 2 Pilot Study. Clin Genitourin Cancer. 2019 Apr;17(2):e323-e328. doi: 10.1016/j.clgc.2018.12.009. Epub 2019 Jan 2.

  PMID: 30686756 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Metformin; abiraterone

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)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• michael mark, md

  Kantonsspital Graubünden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant medical director

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: September 3, 2012
• Study Start: August 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

CH (1)