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

Who is this study for? Adult patients with prostate cancer
What treatments are being studied? Metformin+Stereotactic Body Radiation Therapy
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Institut de Cancerologie de L'Ouest
RECRUITING
Angers
CHRU de BREST - HOPITAL MORVAN
RECRUITING
Brest
Societe de Recherche Oncologique Clinique 37 (Roc 37)
NOT_YET_RECRUITING
Chambray-lès-tours
Centre GEORGES FRANCOIS LECLERC
NOT_YET_RECRUITING
Dijon
Clinique Victor Hugo
NOT_YET_RECRUITING
Le Mans
Centre OSCAR LAMBRET
RECRUITING
Lille
Centre LEON BERARD
RECRUITING
Lyon
Centre Eugene Marquis
NOT_YET_RECRUITING
Rennes
Centre Henri Becquerel
NOT_YET_RECRUITING
Rouen
Institut de Cancerologie de L'Ouest
RECRUITING
Saint-herblain
ICANS - Institut de cancérologie Strasbourg Europe
RECRUITING
Strasbourg
Chru Bretonneau
NOT_YET_RECRUITING
Tours
Contact Information
Primary
Valentine GUIMAS, MD
valentine.guimas@ico.unicancer.fr
+33 (0)240679916
Backup
Nadia ALLAM, PhD
nadia.allam@ico.unicancer.fr
+33 2 40 67 98 26
Time Frame
Start Date: 2020-11-17
Estimated Completion Date: 2031-11
Participants
Target number of participants: 44
Treatments
Experimental: Metformin + SBRT at total dose of 30 Gray (Gy)
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)
Experimental: Metformin + SBRT at total dose of 36 Gy
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)
Experimental: Metformin + SBRT at total dose of 25 Gy
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 5 Gy (day 0 to day 10)
Related Therapeutic Areas
Sponsors
Leads: Institut Cancerologie de l'Ouest

This content was sourced from clinicaltrials.gov