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Impact of the Addition of Metformin to Abiraterone in Metastatic Prostate Cancer Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT01677897•Kantonsspital Graubünden

View on ClinicalTrials.gov

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

Detailed 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

Eligibility

Age

18 - 90 years

Sex

MALE

Healthy Volunteers

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.
+5 more criteria

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.
+6 more criteria

Locations (1)

Kantonsspital Graubünden

Chur, Kanton Graubünden, Switzerland

Key Dates

Start Date

August 1, 2013

Primary Completion Date

December 1, 2017

Completion Date

June 1, 2018

Last Updated

March 5, 2019

Enrollment

ACTUAL participants

Conditions

Metastatic Prostate Cancer

Interventions

Metformin

DRUG

Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer

NCT07181161

Metastatic Prostate Cancer

View study

RECRUITINGPHASE2

Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

NCT06616597

Prostate Cancer (Adenocarcinoma)Metastatic Prostate Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer

Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

Physician- and Patient-based Barriers to NGS Testing

Intrinsic Validity of Molecular Marker(s) Detection on Tissular Tumoral DNA to Predict the Efficacy of 177Lutetium-PSMA-617 (Lu-PSMA) Treatment for Castration-resistant Metastatic Prostate Cancer

Comparison of Different Methods of CAPTure of Circulating Tumour Cells (CTC) in Patients With Metastatic Breast or Prostate Cancer

Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression