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Trial record 50 of 6681 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

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)

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ClinicalTrials.gov Identifier: NCT03417336
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

Brief Summary:

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)

Condition or disease Intervention/treatment Phase
To Evaluate the Rate of Digestive and Urinary Toxicity Radiation: prostatic boost in brachytherapy with high dose rate (HDR) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : January 1, 2023

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)




Primary Outcome Measures :
  1. The rate of digestive and urinary toxicity accumulated at 3 months [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT03417336


Contacts
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Contact: Magalie QUIVRIN 03.80.73.75.00 mquivrin@cgfl.fr
Contact: Emilie REDERSTORFF 03 45 34 81 16 erederstorff@cgfl.fr

Locations
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France
Centre Georges François Leclerc Recruiting
Dijon, France, 21000
CGFL Recruiting
Dijon, France, 21079
Contact: Emilie REDERSTORFF, PhD    +33 (0)3 80 73 75 00 ext 34 61    ERederstorff@cgfl.fr   
Sponsors and Collaborators
Centre Georges Francois Leclerc

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Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT03417336     History of Changes
Other Study ID Numbers: 2017-A00042-51
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms