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

Metastatic Prostate Cancer Clinical Trial

— MetAb-Pro  

Official title:

Impact of the Addition of Metformin to Abiraterone in Pre-docetaxel Metastatic Castration-resistant Prostate Cancer Patients Progressing on Abiraterone Treatment (MetAb-Pro): a Phase II Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677897
• Other study ID #: MetAb-Pro
• Status: Completed
• Phase: Phase 2
• Start date: August 2013
• Est. completion date: June 2018

Study information

• Verified date: March 2019
• Source: Kantonsspital Graubünden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Patients treated with anti-androgens such as flutamide or bicalutamide, if not discontinued at least 4 weeks prior to registration in case of response or in case of no response 2 weeks prior to inclusion for wash-out reasons.

• 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.

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Metformin
Adding Metformin to Abiraterone in case of PSA-Progression

Locations

Country	Name	City	State
Switzerland	Kantonsspital Graubünden	Chur	Graubünden

Sponsors (2)

Lead Sponsor	Collaborator
Kantonsspital Graubünden	Janssen-Cilag Ltd.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	progression free survival at 24 weeks		at 24 weeks
Other	progression free survival		up to 24 weeks
Other	psa response		at 12 weeks
Other	number of adverse events according to the NCI CTCAE v4.0		up to 24 weeks
Primary	progression free survival		at 12 weeks
Secondary	overall survival		up to 2 years