NCT04536805 Relapse in Previously Irradiated Prostate Bed : Stereotactic Ablative Reirradiation Potentiated by Metformin
| NCT ID | NCT04536805 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Institut Cancerologie de l'Ouest |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2020-11-17 |
| Primary Completion | 2031-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 44 participants in total. It began in 2020-11-17 with a primary completion date of 2031-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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.
Contact & Investigator
Valentine GUIMAS, MD
PRINCIPAL INVESTIGATOR
Institut de Cancérologie de l'Ouest
Frequently Asked Questions
Who can join the NCT04536805 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04536805 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04536805 currently recruiting?
Yes, NCT04536805 is actively recruiting participants. Contact the research team at valentine.guimas@ico.unicancer.fr for enrollment information.
Where is the NCT04536805 trial being conducted?
This trial is being conducted at Angers, France, Brest, France, Chambray-lès-Tours, France, Dijon, France and 8 additional locations.
Who is sponsoring the NCT04536805 clinical trial?
NCT04536805 is sponsored by Institut Cancerologie de l'Ouest. The principal investigator is Valentine GUIMAS, MD at Institut de Cancérologie de l'Ouest. The trial plans to enroll 44 participants.
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