Study of the Response to Irradiation on Prostatic Explants ex Vivo, as a Predictive Factor of the Clinical Response to Irradiation of Prostate Cancers

NCT ID: NCT03961737

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2023-06-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

prostatic explants

A first series of biopsies will be performed during the procedure to place the gold grains prior to radiotherapy. Explants will be performed from these biopsies. Half of these explants will be irradiated with a research irradiator at a dose of 2 Gy then placed for 24 hours in an appropriate culture medium. The other half will be directly cultured for 24 hours. After 24 hours of incubation, half of the irradiated explants and half of the explants will be used to study the transcriptome. The tissues will be stored in RNAlater solution and then frozen at -80°C. The remaining half explants will be used for immunohistochemical analysis. Two years after the end of radiotherapy, a new series of biopsies will be performed for research, in order to verify histologically the effectiveness of radiotherapy.

Group Type: EXPERIMENTAL

prostate biopsies

Intervention Type: PROCEDURE

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.

Interventions

prostate 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphane SUPIOT, MD

Role: PRINCIPAL_INVESTIGATOR

ICO

Locations

ICO

Saint-Herblain, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Stéphane SUPIOT, MD

Role: CONTACT

stephane.supiot@ico.unicancer.fr

+33240679900

Emilie DEBEAUPUIS

Role: CONTACT

emilie.debeaupuis@ico.unicancer.fr

Facility Contacts

STEPHANE SUPIOT, MD

Role: primary

stephane.supiot@ico.unicancer.fr

+33240679900

Other Identifiers

ICO-N-2016-05

Identifier Type: -

Identifier Source: org_study_id