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Metastatic Prostate CancerPhase 2MetAb-ProNCT01677897

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

A Phase 2 study testing Metformin in people with Metastatic Prostate Cancer, run by Kantonsspital Graubünden at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 90 years, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteSwitzerland
Study dates
Aug 2013to Jun 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Kantonsspital Graubünden

    Chur, Kanton Graubünden, 7000

Other trials in Switzerland

About this study

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

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

Read the 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

Being tested
Metformin
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Also called Abiraterone

    Adding Metformin to Abiraterone in case of PSA-Progression

Study groups in NCT01677897
Study groupRoleWhat they receive
MetforminExperimentalMetformin 2x1000mg orally per day
Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival

    Measured: at 12 weeks

Secondary outcomes (1)

  1. overall survival

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2012 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2017
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01677897
Sponsor's protocol ID
MetAb-Pro
Acronym
MetAb-Pro
Status last verified
Mar 2019
First submitted
28 Aug 2012
Last updated
5 Mar 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30686756

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Metformin in people with Metastatic Prostate Cancer, run by Kantonsspital Graubünden at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01677897, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.

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