Rechute dans un lit prostatique précédemment irradié: une étude de phase I / II sur la réirradiation ablative stéréotaxique potentialisée par la metformine

Essai clinique

Type : Académique
Statut : Ouvert
Phase : I
Étape du traitement : Radiothérapie
Étape de prise en charge : Rechute
Date d'ouverture : 17/11/2020
Date clôture : 30/11/2028
Promoteur : Institut Cancerologie de l'Ouest
Progression du cancer: Pas de progression
Résumé :

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.

Domaines/spécialités :
  • Cancers uro-génitaux
    • Prostate
Pathologies :
  • Tumeur maligne de la prostate - Cim10 : C61
Liens externes :

Critères de population

Sexe : Homme
Age minimum : 18 ans
Critères d’inclusion :
  • 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 of the prostate lodge and/or 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 2 successive assays) and radiological (lesion visible on MRI and/or Choline PET and/or Prostate-Specific Membrane Antigen (PSMA) PET) or histological examinations.
  • Recurrence without rectal invasion
  • Remote recurrence from vesico-urethral anastomosis (> 10 mm) to limit urinary toxicity
  • Macroscopic Target Volume (GTV) ≤ 27cm3 to limit toxicity
  • 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
  • PSA ≤ 10 ng / ml
  • 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.
Critères d’exclusion :
  • Metastatic disease (bone, lymph node or other)
  • Late radiotherapy urinary or gastrointestinal toxicity (grade ≥ 2) (after radiotherapy of prostate lodge)
  • History of cancer in the 5 years prior to trial entry other than cutaneous basal cell carcinoma
  • Inflammatory bowel disease
  • Contraindications for performing MRI
  • Volume of the GTV > 27 cm3
  • Presence of grade 3 rectal telangiectasia classified by the Vienna Rectoscopy score (Rectoscopy required) (Appendix 7)
  • Rectal surgery history
  • Diabetic patient with HBA1C > laboratory normal value
  • Creatinine clearance < 45 mL/min
  • Treatment with metformin in the last 3 months prior to inclusion

  • Severe comorbidity that may affect treatment, for example :

    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of inclusion.
    • Unstable angina, myocardial infarction and/or congestive heart failure requiring hospitalization within the last 6 months
    • Myocardial infarction in the last 6 months.
    • Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) or other respiratory conditions requiring hospitalization or preventing metformin therapy at the time of inclusion.
  • Any condition associated with an increased risk of lactic acidosis (e.g., alcohol abuse, New York Heart Association (NYHA) III or IV congestive heart failure).
  • Clinically significant history of hepatopathy with Child-Pugh B or C score, including viral infection or hepatitis, alcohol abuse or cirrhosis.
  • Any acute or chronic condition that may result in tissue hypoxia (e.g. heart or respiratory failure, shock).
  • Bilateral hip prosthesis
  • Treatment with any investigational drug or participation in a clinical trial within 30 days prior to inclusion.
  • Known hypersensitivity to metformin or any of its components
  • Inability or reluctance to swallow oral medications
  • Persons deprived of liberty, under a measure of safeguard of justice, under guardianship or under the tutor authority
  • Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.

Centres d'investigation

En cours
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Nom : Dr QUIVRIN
Prénom : Magali
Téléphone : Non disponible
Email : mquivrin@cgfl.fr
CONTACT TECHNIQUE
Nom : Patricia
Prénom : LECERF
Téléphone : 03 45 34 80 84
Email : plecerf@cgfl.fr
Terminée
Nom : ICANS
Ville : Strasbourg
RESPONSABLE MÉDICAL
Aucun responsable médical renseigné
CONTACT TECHNIQUE
Nom : Unité recherche clinique
Prénom : ICANS
Téléphone : Non disponible
Email : recherche-clinique@icans.eu

Référentiels Oncologik

  • Prostate