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Relapse in Previously Irradiated Prostate Bed : Stereotactic Ablative Reirradiation Potentiated by Metformin

NCT04536805 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-12-08

No results posted yet for this study

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

Conditions

Interventions

DRUG

Metformin

Metformin: 850 mg per day (day -15 to day 0) 1700 mg per day (day 1 to day 75)

RADIATION

Stereotactic Body Radiation Therapy (SBRT) 30 Gray (Gy)

Stereotactic Body Radiation Therapy (SBRT): Dose escalation 5 x 6 Gy day 0 to day 10

RADIATION

Stereotactic Body Radiation Therapy (SBRT) 36 Gy

Stereotactic Body Radiation Therapy (SBRT): Dose escalation 6 x 6 Gy day 0 to day 12

RADIATION

Stereotactic Body Radiation Therapy (SBRT) 25 Gy

Stereotactic Body Radiation Therapy (SBRT): Dose escalation 5x 5 Gy day 0 to day 10

Sponsors & Collaborators

  • Institut Cancerologie de l'Ouest

    lead OTHER

Principal Investigators

  • Valentine GUIMAS, MD · Institut de Cancérologie de l'Ouest

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2031-11-30
Completion
2031-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04536805 on ClinicalTrials.gov