Study Evaluating the Efficacy and the Tolerance of Pelvic-prostatic Hypo-fractionated Radiotherapy Followed by Boost in Patients With Prostate Adenocarcinoma Adverse Intermediate Risk or High Localized Risk (SHORT)

February 14, 2025 updated by: Centre Georges Francois Leclerc

Multicenter, Randomized, Pilot Study Evaluating the Efficacy and the Tolerance of Pelvic-prostatic Hypo-fractionated Radiotherapy Followed by Boost (Stereotaxic External Radiotherapy or High Dose Rate Brachytherapy) in Patients With Prostate Adenocarcinoma Adverse Intermediate Risk or High Localized Risk

The standard treatment of high-risk prostatic adenocarcinoma is based on pelvic-prostatic external radiotherapy combined with concomitant and adjunctive hormone therapy for a total of 3 years.

Prostatic stereotactic radiotherapy in 5 sessions is a therapeutic option currently delivered and described in multiple cohorts of patients with a tolerance comparable to normo-fractional treatments. This therapeutic scheme makes it possible to deliver a higher equivalent biological dose than during a treatment carried out with a conventional fractionation.

The results with a follow-up of 9 years are extremely encouraging and do not show any excess toxicity compared to other irradiation techniques. They confirm that urinary and digestive toxicities are acceptable. All these studies did not involve pelvic irradiation. Several trials have also demonstrated the feasibility of normofractionated pelvic irradiation associated with hypofractionated prostatic irradiation using an integrated boost technique.

The primary objective is to evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with:To evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with:

  • a prostatic boost in brachytherapy with high dose rate (HDR) or
  • an integrated boost in stereotaxis (in case of contraindication to brachytherapy)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Dijon, France, 21000
        • Recruiting
        • Centre Georges François Leclerc
      • Dijon, France, 21079
        • Recruiting
        • CGFL
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adenocarcinoma of the prostate

  2. Patient with one of the following cases:

    • Gleason 7 - 10 + T1c - T2b + PSA < 50 ng/mL or
    • Gleason 6 + T2c - T4 ou envahissement ≥ 50% sur les biopsies + PSA < 50 ng/mL or
    • Gleason 6 + T1c - T2b + PSA > 20 ng/mL
  3. Risk of lymph node involvement> 15%
  4. Patient N0, or Nx
  5. Prostate volume estimated on MRI or ultrasound less than 60 cc.
  6. Absence of pelvic lymphadenopathy ≥ 15 mm on CT or MRI extension assessment
  7. Lack of bone and / or visceral metastasis on CT scan and bone scintigraphy
  8. Hormonal treatment started maximum 90 days before the beginning of the irradiation,
  9. IPSS score <12 without alpha blocker treatment
  10. Absence of prior pelvic radiotherapy,
  11. Lack of surgical treatment for prostate cancer except transurethral resection performed within 6 months before radiotherapy,
  12. Age ≥ 18 years and ≤ 85 years,
  13. WHO performance index ≤ 1,
  14. Estimated life expectancy> 5 years,
  15. Indication of treatment with radiotherapy and validated hormone therapy in a multidisciplinary consultation meeting
  16. Affiliation to a social security scheme,
  17. Signed informed consent.

Exclusion Criteria:

  1. Prostate cancer of histology other than adenocarcinoma,
  2. Patient diagnosed with N1 during imaging or pN1,
  3. serum PSA level> 100 ng / ml,
  4. IPSS score ≥ 12 or alpha blocker treatment,
  5. Prostate volume estimated on MRI or ultrasound> 60 cc
  6. History of cancer in the 5 years prior to entry into the trial,
  7. History of trans-urethral resection of prostate less than 6 months old,
  8. History of rectal surgery,
  9. History of pelvic irradiation,
  10. Patient with severe hypertension not controlled by appropriate treatment,
  11. Contraindication to pelvic irradiation,

  12. Patient not eligible for brachytherapy

    • Prostate volume> 60cc
    • Urine flow measurement with max flow <12 mL / s
    • Or curative anticoagulant treatment
    • Or contraindication to general anesthesia
  13. Patient treated with antineoplastic or drug may include methotrexate,
  14. Hormone therapy started> 90 days before the first irradiation,
  15. Patient on immunosuppressant therapy
  16. Contraindication to agonists or antagonists of LHRH,
  17. Bilateral hip prosthesis,
  18. Patient already included in another therapeutic trial with an experimental molecule,
  19. Patient unable to cooperate during treatment,
  20. Persons deprived of their liberty or guardianship,
  21. Inability to undergo medical follow-up of the test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: brachytherapy + External radiotherapy
Prostate booster, HDR brachytherapy with 15Gy in 1 fraction + external radiotherapy 25Gy in 5 fractions
Radiation: prostatic boost in brachytherapy with high dose rate (HDR)
prostatic boost in brachytherapy with high dose rate (HDR)
Active Comparator: External radiotherapy
Exclusive external radiotherapy. 25Gy in 5 fractions + a 40Gy prostate boost in stereotaxic conditions.
Radiation: prostatic boost in brachytherapy with high dose rate (HDR)
prostatic boost in brachytherapy with high dose rate (HDR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of digestive and urinary toxicity accumulated at 3 months
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2018

Primary Completion (Estimated)

April 24, 2029

Study Completion (Estimated)

April 24, 2029

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

January 24, 2018

First Posted (Actual)

January 31, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A00042-51

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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