Prostate Cancer
Conditions
Keywords
radiotherapy, explants, transcriptomic, immunohistochemistry
Brief summary
Of the 50,000 prostate cancers that occur each year in France, more than half will benefit from curative radiotherapy, alone or in combination with hormone therapy from 6 months to 3 years depending on the stage of the disease. At present, there are few ways to predict the response to this irradiation. Evaluating the early response of tumor tissue to irradiation could predict the final response to treatment. It is difficult to offer biopsies during treatment for reasons of patient comfort. This is why this study consists in analysing transcriptomic and protein responses (immunohistochemistry) to irradiation on ex vivo prostate explants. These explants will be irradiated after culture and the transcriptional and immunohistochemical changes analysed before and after irradiation to determine an early tumor tissue response profile to irradiation.
Interventions
PROCEDUREprostate biopsies
Before radiotherapy treatment, prostate biopsies will be performed in each patient. From these biopsies, explants will be performed. Half of these explants will be irradiated ex vivo and the other half will not receive any prior treatment. Then the patient will receive radiotherapy. It will be reviewed 2 years after the end of radiotherapy. New prostate biopsies will be performed to evaluate the tumor response to radiotherapy and to characterize the immunohistochemical and transcriptomic profiles of non-responder patients.
Sponsors
Institut Cancerologie de l'Ouest
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years old 2. Patient with non-operated prostate adenocarcinoma for whom radiotherapy treatment is scheduled 3. Signed Informed Consent 4. No contraindications to biopsy performance: * No anticoagulant treatment in progress * Absence of infection during diagnostic biopsies * Absence of pain requiring level 2 analgesics during diagnostic biopsies * Absence of bleeding complications during diagnostic biopsies * Absence of anal stenosis 5. Normal coagulation examination : * Prothrombin Ratio between 80 and 100%. * Active Cephalin Time from 24 to 41 seconds, \> 1.5 times that of the indicator * Platelets \> 150,000 G/L * International Normalised Ratio(INR) = 1 after stopping the anticoagulant 6. No contraindication to MRI: * Ocular metallic foreign body * Pacemaker * Old mechanical heart valve * Ancient vascular clips on cranial aneurysms
Exclusion criteria
1. History of radical prostatectomy. A history of transurethral prostate resection is not a contraindication 2. History of prostate infection 3. Hemorrhagic complications in diagnostic biopsies 4. Pain requiring level 2 analgesics in diagnostic biopsies 5. Anticoagulant treatment in progress (aspirin will be stopped 1 week before biopsies are performed) 6. Abnormal coagulation assessment 7. Anal stenosis 8. Contraindications to radiotherapy: chronic inflammatory bowel disease, scleroderma 9. Protected or tutored patient 10. Patient whose follow-up at two years is not possible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| biopsy tumor response | 24 months after radiotherapy | The centralized anatomopathological study of prostate biopsies will classify patients into good responders (absence of viable tumour cells) and poor responders (persistence of viable tumour cells). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Biochemical response to radiotherapy. | every 6 months for a maximum total of 24 months | Biological response to radiotherapy the biological response to radiotherapy is assessed by measuring serum PSA levels according to Phoenix criteria, nadir 2 ng/ml |
| prostatic Magnetic Resonance Imaging | 24 months after radiotherapy | Prostate MRI 2 years after the end of radiotherapy, used to identify the area affected by the tumor |
Countries
France
Contacts
Primary ContactStéphane SUPIOT, MD
Backup ContactEmilie DEBEAUPUIS
Outcome results
None listed