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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03961737
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: prostate biopsies Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Procedure: 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.

Primary Outcome Measures :
  1. biopsy tumor response [ Time Frame: 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 Outcome Measures :
  1. Change in Biochemical response to radiotherapy. [ Time Frame: 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

  2. prostatic Magnetic Resonance Imaging [ Time Frame: 24 months after radiotherapy ]
    Prostate MRI 2 years after the end of radiotherapy, used to identify the area affected by the tumor

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03961737

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Contact: Emilie DEBEAUPUIS 02 40 67 99 00 ext 9048

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ICO Recruiting
Saint-Herblain, France, 44805
Contact: STEPHANE SUPIOT, MD    02 40 67 99 13   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
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Principal Investigator: Stéphane SUPIOT, MD ICO

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Responsible Party: Institut Cancerologie de l'Ouest Identifier: NCT03961737     History of Changes
Other Study ID Numbers: ICO-N-2016-05
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Cancerologie de l'Ouest:

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases