Actively Recruiting
Relapse in Previously Irradiated Prostate Bed : Stereotactic Ablative Reirradiation Potentiated by Metformin
Led by Institut Cancerologie de l'Ouest · Updated on 2025-12-08
44
Participants Needed
12
Research Sites
571 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Relapse in Previously Irradiated Prostate Bed : Stereotactic Ablative Reirradiation Potentiated by Metformin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent before any study procedures
- Biochemical recurrence at least 2 years after external radiotherapy and hormone therapy for prostate adenocarcinoma treated by radical prostatectomy
- Local recurrence confirmed by rising PSA (above 0.2 ng/ml with 2 successive tests) and visible lesion on MRI or PET scans
- No rectal invasion at recurrence
- Pelvic and prostate MRI evaluation completed
- No pelvic lymph node or metastatic recurrence confirmed by PET scan
- WHO performance status 0-1
- Low, intermediate, or high risk with a single risk factor
- PSA doubling time greater than 6 months
- No anti-cancer treatments planned for current relapse
- Age 18 years or older
- Life expectancy of at least 5 years
- Registered with a health insurance system
- Willing and able to comply with visits, treatment, lab tests, and study procedures
You will not qualify if you...
- Metastatic disease including bone, lymph node, or other sites
- Late radiotherapy urinary or gastrointestinal toxicity grade 2 or higher
- History of cancer in the past 5 years except for basal cell skin carcinoma
- Inflammatory bowel disease
- Contraindications to MRI
- History of rectal surgery
- Current treatment for diabetes
- Creatinine clearance below 45 mL/min
- Metformin treatment within 3 months before inclusion
- Severe comorbidities affecting treatment such as active infections needing IV antibiotics, recent unstable angina, myocardial infarction or heart failure hospitalization within 6 months
- Exacerbation of COPD or respiratory conditions preventing metformin use
- Conditions increasing risk of lactic acidosis like alcohol abuse or severe heart failure
- Significant liver disease with Child-Pugh B or C score
- Acute or chronic tissue hypoxia conditions
- Bilateral hip prosthesis
- Use of investigational drugs or participation in other trials within 30 days
- Known allergy to metformin or its components
- Inability or unwillingness to swallow oral medications
- Legal guardianship or restricted liberty
- Inability to attend medical monitoring for social, psychological, or geographic reasons
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Institut de Cancerologie de L'Ouest
Angers, France, 49055
Actively Recruiting
2
CHRU de BREST - HOPITAL MORVAN
Brest, France, 29200
Actively Recruiting
3
Societe de Recherche Oncologique Clinique 37 (Roc 37)
Chambray-lès-Tours, France, 37170
Not Yet Recruiting
4
Centre GEORGES FRANCOIS LECLERC
Dijon, France, 21079
Not Yet Recruiting
5
Clinique Victor Hugo
Le Mans, France, 72100
Not Yet Recruiting
6
Centre OSCAR LAMBRET
Lille, France, 59020
Actively Recruiting
7
Centre LEON BERARD
Lyon, France, 69373
Actively Recruiting
8
Centre Eugene Marquis
Rennes, France, 35042
Not Yet Recruiting
9
Centre Henri Becquerel
Rouen, France, 76038
Not Yet Recruiting
10
Institut de Cancerologie de L'Ouest
Saint-Herblain, France, 44805
Actively Recruiting
11
ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, France, 67200
Actively Recruiting
12
Chru Bretonneau
Tours, France, 37044
Not Yet Recruiting
Research Team
V
Valentine GUIMAS, MD
CONTACT
N
Nadia ALLAM, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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