Clinical trial · Interventional
Relapse in Previously Irradiated Prostate Bed : Stereotactic Ablative Reirradiation Potentiated by Metformin
Relapse in Previously Irradiated Prostate Bed : a Phase I/II Study of Stereotactic Ablative Reirradiation Potentiated by Metformin
NCT04536805CI-TRIAL-00115638REPAIRactive not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I/II escalation dose study is assessing the efficacy of the recommended dose of stereotactic re-irradiation (SBRT) of relapses within the prostatectomy bed, potentiated by metformin
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Stereotactic Body Radiation Therapy (SBRT) 25 Gy | Radiation | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy (SBRT) 30 Gray (Gy) | Radiation | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy (SBRT) 36 Gy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Metformin + SBRT at total dose of 30 Gray (Gy)
- description
- Metformin: 850 mg per day (day -15 to day 0) 1700 mg per day (day 1 to day 75) Stereotactic Body Radiation Therapy (SBRT): Dose escalation 5 x 6 Gy, (day 0 to day 10)
- interventionNames
- Drug: Metformin
- Radiation: Stereotactic Body Radiation Therapy (SBRT) 30 Gray (Gy)
- type
- EXPERIMENTAL
- label
- Metformin + SBRT at total dose of 36 Gy
- description
- Metformin: 850 mg per day (day -15 to day 0) 1700 mg per day (day 1 to day 75) Stereotactic Body Radiation Therapy (SBRT): Dose escalation 6 x 6 Gy (day 0 to day 12)
- interventionNames
- Drug: Metformin
- Radiation: Stereotactic Body Radiation Therapy (SBRT) 36 Gy
- type
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDJoly A, Blanc Lapierre A, Rio E, Vaugier L, Supiot S, Guimas V. REPAIR_GETUG P16 relapse in previously irradiated prostate bed: a phase I/II study of stereotactic ablative reirradiation potentiated by a metformine study protocol. BMJ Open. 2025 Jul 24;15(7):e100031. doi: 10.1136/bmjopen-2025-100031. PMID 40707156