NCT04536805

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The purpose of this escalation study is, first to select the recommended dose of re-irradiation SBRT in combination with Metformin (based on treatment toxicity monitoring) and then to estimate the efficacy of re-irradiation SBRT in combination with Metformin. Five or six fractions, at a level of 5 or 6 Gray (Gy) per session (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy), will be delivered over a maximum of 12 days (from day 1 to day 10 or 12) to provide a total dose of 25 to 36 Gy. Patient receive oral Metformin treatment from Day -15 and Day 75. Patient will be followed for 5 years: patients visits will be planned at week 2; 4; 8; 12; and month M6; M9; M12; M18; M24; M36; 4 years and 5 years.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-17
• Primary completion: 2031-11-01
• Completion: 2031-11-01
• First posted: 2020-09-03
• Last updated: 2025-12-08

Locations

12 sites across 1 country: France