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RECRUITING
NCT04536805
PHASE1/PHASE2

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

Sponsor: Institut Cancerologie de l'Ouest

View on ClinicalTrials.gov

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

Official title: Relapse in Previously Irradiated Prostate Bed : a Phase I/II Study of Stereotactic Ablative Reirradiation Potentiated by Metformin

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2020-11-17

Completion Date

2031-11

Last Updated

2025-12-08

Healthy Volunteers

No

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

Locations (12)

Institut de Cancerologie de L'Ouest

Angers, France

CHRU de BREST - HOPITAL MORVAN

Brest, France

Societe de Recherche Oncologique Clinique 37 (Roc 37)

Chambray-lès-Tours, France

Centre GEORGES FRANCOIS LECLERC

Dijon, France

Clinique Victor Hugo

Le Mans, France

Centre OSCAR LAMBRET

Lille, France

Centre LEON BERARD

Lyon, France

Centre Eugene Marquis

Rennes, France

Centre Henri Becquerel

Rouen, France

Institut de Cancerologie de L'Ouest

Saint-Herblain, France

ICANS - Institut de cancérologie Strasbourg Europe

Strasbourg, France

Chru Bretonneau

Tours, France