Status:
RECRUITING
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
Lead Sponsor:
Centre Georges Francois Leclerc
Conditions:
To Evaluate the Rate of Digestive and Urinary Toxicity
Eligibility:
MALE
18-85 years
Phase:
NA
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. Prosta...
Eligibility Criteria
Inclusion
- Adenocarcinoma of the prostate
- 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
- Risk of lymph node involvement\> 15%
- Patient N0, or Nx
- Prostate volume estimated on MRI or ultrasound less than 60 cc.
- Absence of pelvic lymphadenopathy ≥ 15 mm on CT or MRI extension assessment
- Lack of bone and / or visceral metastasis on CT scan and bone scintigraphy
- Hormonal treatment started maximum 90 days before the beginning of the irradiation,
- IPSS score \<12 without alpha blocker treatment
- Absence of prior pelvic radiotherapy,
- Lack of surgical treatment for prostate cancer except transurethral resection performed within 6 months before radiotherapy,
- Age ≥ 18 years and ≤ 85 years,
- WHO performance index ≤ 1,
- Estimated life expectancy\> 5 years,
- Indication of treatment with radiotherapy and validated hormone therapy in a multidisciplinary consultation meeting
- Affiliation to a social security scheme,
- Signed informed consent.
Exclusion
- Prostate cancer of histology other than adenocarcinoma,
- Patient diagnosed with N1 during imaging or pN1,
- serum PSA level\> 100 ng / ml,
- IPSS score ≥ 12 or alpha blocker treatment,
- Prostate volume estimated on MRI or ultrasound\> 60 cc
- History of cancer in the 5 years prior to entry into the trial,
- History of trans-urethral resection of prostate less than 6 months old,
- History of rectal surgery,
- History of pelvic irradiation,
- Patient with severe hypertension not controlled by appropriate treatment,
- Contraindication to pelvic irradiation,
- 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
- Patient treated with antineoplastic or drug may include methotrexate,
- Hormone therapy started\> 90 days before the first irradiation,
- Patient on immunosuppressant therapy
- Contraindication to agonists or antagonists of LHRH,
- Bilateral hip prosthesis,
- Patient already included in another therapeutic trial with an experimental molecule,
- Patient unable to cooperate during treatment,
- Persons deprived of their liberty or guardianship,
- Inability to undergo medical follow-up of the test.
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 24 2029
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03417336
Start Date
January 24 2018
End Date
April 24 2029
Last Update
February 17 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Georges François Leclerc
Dijon, France, 21000
2
CGFL
Dijon, France, 21079