Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a diabetes drug boost radiation to fight returning prostate cancer?

NCT ID NCT04536805

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is for men whose prostate cancer has returned in the same area after they already had radiation and surgery. The researchers want to see if giving a very precise, high-dose radiation treatment (called SBRT) along with the diabetes drug metformin can safely control the cancer again. About 44 participants will receive different radiation doses to find the best one. The study will track PSA levels for up to 5 years to see how well the treatment works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Written informed consent according to International Conference on Harmonisation (ICH)/ Good Clinical Practice (GCP) regulations before registration and prior to any trial specific procedures. * Biochemical recurrence occurring at least 2 years after external radiotherapy to the prostate lodge and the end of hormone therapy, for prostatic adenocarcinoma previously treated by radical prostatectomy. * Local recurrence in irradiated areas proven by biological (PSA \> 0.2 ng/ml and ascending confirmed by at least 2 successive assays) and radiological (lesion visible on MRI and/or Choline PET and/or Prostate-Specific Membrane Antigen (PSMA) PET). * Recurrence without rectal invasion * Pelvic and prostate MRI evaluation * Absence of pelvic lymph node or metastatic recurrence proven by choline PET or PSMA PET scan * World Health Organisation (WHO) performance status 0-1 * Low risk, intermediate risk and high risk with a single risk factor * PSA doubling time \> 6 months * No anti-cancer treatments planned for the current relapse, including hormone therapy. * Age \> 18 years old. * Life expectancy greater than or equal to 5 years. * Patient registered with a health insurance system. * Patients willing and able to comply with the planned visits, treatment plan, laboratory tests and other study procedures indicated in the protocol. Exclusion Criteria: * Metastatic disease (bone, lymph node or other) * Late radiotherapy urinary or gastrointestinal toxicity (grade ≥ 2) (after radiotherapy of prostate lodge) * History of cancer in the 5 years prior to trial entry other than cutaneous basal cell carcinoma * Inflammatory bowel disease * Contraindications for performing MRI * Rectal surgery history * Patient treated for Diabetes * Creatinine clearance \< 45 mL/min * Treatment with metformin in the last 3 months prior to inclusion * Severe comorbidity that may affect treatment, for example : * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of inclusion. * Unstable angina, myocardial infarction and/or congestive heart failure requiring hospitalization within the last 6 months * Myocardial infarction in the last 6 months. * Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) or other respiratory conditions requiring hospitalization or preventing metformin therapy at the time of inclusion. * Any condition associated with an increased risk of lactic acidosis (e.g., alcohol abuse, New York Heart Association (NYHA) III or IV congestive heart failure). * Clinically significant history of hepatopathy with Child-Pugh B or C score, including viral infection or hepatitis, alcohol abuse or cirrhosis. * Any acute or chronic condition that may result in tissue hypoxia (e.g. heart or respiratory failure, shock). * Bilateral hip prosthesis * Treatment with any investigational drug or participation in a clinical trial within 30 days prior to inclusion. * Known hypersensitivity to metformin or any of its components * Inability or reluctance to swallow oral medications * Persons deprived of liberty, under a measure of safeguard of justice, under guardianship or under the tutor authority * Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Prostate adenocarcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHRU de BREST - HOPITAL MORVAN

    Brest, 29200, France

  • Centre Eugene Marquis

    Rennes, 35042, France

  • Centre GEORGES FRANCOIS LECLERC

    Dijon, 21079, France

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre LEON BERARD

    Lyon, 69373, France

  • Centre OSCAR LAMBRET

    Lille, 59020, France

  • Chru Bretonneau

    Tours, 37044, France

  • Clinique Victor Hugo

    Le Mans, 72100, France

  • ICANS - Institut de cancérologie Strasbourg Europe

    Strasbourg, 67200, France

  • Institut de Cancerologie de L'Ouest

    Angers, 49055, France

  • Institut de Cancerologie de L'Ouest

    Saint-Herblain, 44805, France

  • Societe de Recherche Oncologique Clinique 37 (Roc 37)

    Chambray-lès-Tours, 37170, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.