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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
prostate biopsies
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer focused on measuring radiotherapy, explants, transcriptomic, immunohistochemistry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • ICORecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

prostatic explants

Arm Description

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.

Outcomes

Primary Outcome Measures

biopsy tumor response
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 Outcome Measures

Change in Biochemical response to radiotherapy.
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
Prostate MRI 2 years after the end of radiotherapy, used to identify the area affected by the tumor

Full Information

First Posted
May 15, 2019
Last Updated
April 21, 2022
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT03961737
Brief Title
Study of the Response to Irradiation on Prostatic Explants ex Vivo, as a Predictive Factor of the Clinical Response to Irradiation of Prostate Cancers
Acronym
EXPLANT
Official Title
Study of the Response to Irradiation on Prostatic Explants ex Vivo, as a Predictive Factor of the Clinical Response to Irradiation of Prostate Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
radiotherapy, explants, transcriptomic, immunohistochemistry

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prostatic explants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
prostate biopsies
Intervention Description
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.
Primary Outcome Measure Information:
Title
biopsy tumor response
Description
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).
Time Frame
24 months after radiotherapy
Secondary Outcome Measure Information:
Title
Change in Biochemical response to radiotherapy.
Description
Biological response to radiotherapy the biological response to radiotherapy is assessed by measuring serum PSA levels according to Phoenix criteria, nadir 2 ng/ml
Time Frame
every 6 months for a maximum total of 24 months
Title
prostatic Magnetic Resonance Imaging
Description
Prostate MRI 2 years after the end of radiotherapy, used to identify the area affected by the tumor
Time Frame
24 months after radiotherapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years old Patient with non-operated prostate adenocarcinoma for whom radiotherapy treatment is scheduled Signed Informed Consent 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 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 No contraindication to MRI: Ocular metallic foreign body Pacemaker Old mechanical heart valve Ancient vascular clips on cranial aneurysms Exclusion Criteria: History of radical prostatectomy. A history of transurethral prostate resection is not a contraindication History of prostate infection Hemorrhagic complications in diagnostic biopsies Pain requiring level 2 analgesics in diagnostic biopsies Anticoagulant treatment in progress (aspirin will be stopped 1 week before biopsies are performed) Abnormal coagulation assessment Anal stenosis Contraindications to radiotherapy: chronic inflammatory bowel disease, scleroderma Protected or tutored patient Patient whose follow-up at two years is not possible
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane SUPIOT, MD
Phone
+33240679900
Email
stephane.supiot@ico.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie DEBEAUPUIS
Email
emilie.debeaupuis@ico.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane SUPIOT, MD
Organizational Affiliation
ICO
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICO
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
STEPHANE SUPIOT, MD
Phone
+33240679900
Email
stephane.supiot@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Stéphane SUPIOT, MD

12. IPD Sharing Statement

Learn more about this trial

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

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