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出境医 / 临床实验 / 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)

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)

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.


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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: N/A
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
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Emilie DEBEAUPUIS 02 40 67 99 00 ext 9048 emilie.debeaupuis@ico.unicancer.fr

Locations
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France
ICO Recruiting
Saint-Herblain, France, 44805
Contact: STEPHANE SUPIOT, MD    02 40 67 99 13    stephane.supiot@ico.unicancer.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
Layout table for investigator information
Principal Investigator: Stéphane SUPIOT, MD ICO
Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE April 2, 2019
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Response to Irradiation on Prostatic Explants ex Vivo, as a Predictive Factor of the Clinical Response to Irradiation of Prostate Cancers
Official Title  ICMJE Study of the Response to Irradiation on Prostatic Explants ex Vivo, as a Predictive Factor of the Clinical Response to Irradiation of Prostate Cancers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Procedure: prostate biopsies
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2019) 		92
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emilie DEBEAUPUIS 02 40 67 99 00 ext 9048 emilie.debeaupuis@ico.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03961737
Other Study ID Numbers  ICMJE ICO-N-2016-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Cancerologie de l'Ouest
Study Sponsor  ICMJE Institut Cancerologie de l'Ouest
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stéphane SUPIOT, MD ICO
PRS Account Institut Cancerologie de l'Ouest
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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