Could a diabetes drug boost radiation to fight returning prostate cancer?
NCT ID NCT04536805
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2020
- Expected to finish
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Nov 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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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
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CHRU de BREST - HOPITAL MORVAN
Brest, 29200, France
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Centre Eugene Marquis
Rennes, 35042, France
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Centre GEORGES FRANCOIS LECLERC
Dijon, 21079, France
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Centre Henri Becquerel
Rouen, 76038, France
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Centre LEON BERARD
Lyon, 69373, France
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Centre OSCAR LAMBRET
Lille, 59020, France
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Chru Bretonneau
Tours, 37044, France
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Clinique Victor Hugo
Le Mans, 72100, France
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ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, 67200, France
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Institut de Cancerologie de L'Ouest
Angers, 49055, France
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Institut de Cancerologie de L'Ouest
Saint-Herblain, 44805, France
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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.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?