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Genital Neoplasms, Male

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Genital Diseases, Male

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Male Urogenital Diseases

Hypoglycemic Agents

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Metformin

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)

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)

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)

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

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

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

Stereotactic Body Radiation Therapy (SBRT) 36 Gy

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

Stereotactic Body Radiation Therapy (SBRT) 25 Gy

Valentine GUIMAS, MD

Nadia ALLAM, PhD

Nathalie MESGOUEZ-NEBOUT, MD

Ulrike SCHICK, MD

Thomas BOISSERIE, MD

Magali QUIVRIN, MD

Amandine RUFFIER LOUBIERE, MD

David PASQUIER, MD

Pascal POMMIER, MD

Pascal POMMIER

Renaud DE CREVOISIER, MD

Maximilien ROGE, MD

Jean-Baptiste Jean-Baptiste, MD

Gilles CALAIS, MD

Gilles CALAIS

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

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.

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

SBRT toxicity will be reported during the 12 weeks following the initiation of SBRT.

PSA levels will be assessed every 3 months within 3 years after SBRT.

PSA levels will be assessed every 3 months within 5 years after SBRT.

For all patients, visits will be made at 6, 9, 12, 18, 24, 36 months, 4 years, and 5 years will be made from the start of SBRT. The end of the trial is defined by the last visit of the last included patient.

Clinical progression-free survival is defined as the time interval between the date of SBRT start and the date of clinical progression (local progression assessed by the physical examination, or appearance of metastatic lesions), start of hormonal therapy or death irrespective of the cause.

Acute and late genitourinary toxicities over the first 5 years will be assessed according to the NCI-CTCAE V5.0 classification

Quality of life will be assessed based on EORTC Quality of life questionnaire (QLQ)-C30 scale at week 4; 8; 12; and month M6; M9; M12; M18; M24; M36; 4 years and 5 years. The Time Until Definitive Deterioration (TUDD) will be computed from registration until the first observation of a definitive deterioration of the quality of life, defined as a score decreased by 10 points (in the case of global health scale and functional scales) or increased by 10 points (in the case of symptom scales) compared to the score at baseline, without later improvement superior to 10 points compared to baseline score.

Quality of life will be assessed based on EORTC Quality of life questionnaire in prostate cancer (QLQ-PR25) scale at week 4; 8; 12; and month M6; M9; M12; M18; M24; M36; 4 years and 5 years. The Time Until Definitive Deterioration (TUDD) will be computed from registration until the first observation of a definitive deterioration of the quality of life, defined as a score decreased by 10 points (in the case of global health scale and functional scales) or increased by 10 points (in the case of symptom scales) compared to the score at baseline, without later improvement superior to 10 points compared to baseline score.

Urinary symptoms over the first 5 years will be assessed by International Prostatic Symptom Score (IPSS). This score evaluates the severity of prostate symptoms in the last month on a scale of 0 to 35 (total of 7 items rated 0 to 5).The distributions of this score will be described at inclusion, at follow-up visits (M6 M9 M12 M18 M24 M36 4 and 5 years) and at the end of the study visit according to the following categories:

0 - 7: Poorly symptomatic ; 8 - 19: Moderately symptomatic ; 20 - 35: Severe symptoms.

Erectile function will be assessed by International Index of Erectile Function (IIEF5). This score assesses erectile function over the past 6 months on a scale of 1 to 25 (total of 5 items rated 0/1 to 5). The distributions of this score will be described at baseline, at follow-up visits (M6 M12 M18, M24,M36 4 and 5 years old) and at the end of the study visit according to the following categories:

1 - 4: Non-interpretable ; 5 - 10: Severe erectile dysfunction ; 11 - 15: Moderate erectile dysfunction ; 16 - 20: Mild erectile dysfunction ; 21 - 25: Normal erectile function.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Relapse in Previously Irradiated Prostate Bed : Stereotactic Ablative Reirradiation Potentiated by Metformin	NCT04536805	Prostate Cancer	Metformin Stereotactic Bo... Stereotactic Bo... Stereotactic Bo...	18 Years -	Institut Cancerologie de l'Ouest
Relapse in Previously Irradiated Prostate Bed : Stereotactic Ablative Reirradiation Potentiated by Metformin	NCT04536805	Prostate Cancer	Metformin Stereotactic Bo... Stereotactic Bo... Stereotactic Bo...	18 Years -	Institut Cancerologie de l'Ouest

Spots Global Cancer Trial Database for previously irradiated prostate bed