Status:
ACTIVE_NOT_RECRUITING
Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma
Lead Sponsor:
Centre Georges Francois Leclerc
Conditions:
Adenocarcinoma of the Prostate
Eligibility:
MALE
18-85 years
Phase:
NA
Brief Summary
Stereotaxic prostatic radiotherapy on Linac MRI, with monitoring of movements of the pelvic organs per fraction on the prostate in real time, in 4 sessions, with integrated boost on the index tumor (i...
Eligibility Criteria
Inclusion
- prostate adenocarcinoma
- WHO performance index ≤ 1
- Patient presenting one of the following cases:
- Low risk: ≤ T2a and Gleason 6 (3 + 3) and PSA \<10 ng / ml
- Intermediate risk: T2b-T2c or Gleason 7 or PSA \<15 ng / ml
- High localized risk: T3a and Gleason ≤7 and PSA \<15 ng / ml
- Disease presenting a risk of lymph node involvement \<15%
- Absence of pelvic or lumbar aortic lymphadenopathy
- Absence of bone or visceral metastasis
- IPSS score \<15 or ≤ 7
- Prostate volume estimated by MRI or ultrasound \< 90cc
- If hormonotherapy, hormone therapy must not have started for more than 60 days before inclusion.
- Absence of prior pelvic radiotherapy
- No surgical treatment for prostate cancer
Exclusion
- Prostate cancer of histology other than adenocarcinoma
- Contraindication to MRI including, but not limited to, patients with a pacemaker or defibrillator
- Patient diagnosed N1 during imaging workup or pN1
- Serum PSA level ≥ 15 ng / ml
- IPSS score ≥ 15 or IPSS score\> 7 if alpha blocking urological treatment in progress
- Prostate volume estimated on MRI or ultrasound\> 90 cc
- Involvement of seminal vesicles on MRI
- History of cancer in the 5 years preceding entry into the trial
- History of transurethral resection of the prostate less than 6 months compared to the expected date of start of radiotherapy
- rectal surgery
- pelvic irradiation
- Patient treated with antineoplastic or medication which may include Methotrexate
- Hormone therapy started for more than 60 days at the time of inclusion
- Severe uncontrolled hypertension
- Patient followed or treated for severe or unstable angina, or having presented a myocardial infarction in the 6 months preceding the randomization
- Patient on immunosuppressant
- Patient with known hypersensitivity to gadoteric acid, meglumine or any drug containing gadolinium
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04909294
Start Date
October 1 2020
End Date
October 1 2030
Last Update
February 13 2024
Active Locations (1)
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1
Centre Georges François Leclerc
Dijon, France, 21000