Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT04909294
Eligibility Criteria:
Inclusion Criteria:
1. prostate adenocarcinoma
2. WHO performance index ≤ 1
3. 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
4. Disease presenting a risk of lymph node involvement \<15%
5. Absence of pelvic or lumbar aortic lymphadenopathy
6. Absence of bone or visceral metastasis
7. IPSS score \<15 or ≤ 7
8. Prostate volume estimated by MRI or ultrasound \< 90cc
9. If hormonotherapy, hormone therapy must not have started for more than 60 days before inclusion.
10. Absence of prior pelvic radiotherapy
11. No surgical treatment for prostate cancer
Exclusion Criteria:
1. Prostate cancer of histology other than adenocarcinoma
2. Contraindication to MRI including, but not limited to, patients with a pacemaker or defibrillator
3. Patient diagnosed N1 during imaging workup or pN1
4. Serum PSA level ≥ 15 ng / ml
5. IPSS score ≥ 15 or IPSS score\> 7 if alpha blocking urological treatment in progress
6. Prostate volume estimated on MRI or ultrasound\> 90 cc
7. Involvement of seminal vesicles on MRI
8. History of cancer in the 5 years preceding entry into the trial
9. History of transurethral resection of the prostate less than 6 months compared to the expected date of start of radiotherapy
10. rectal surgery
11. pelvic irradiation
12. Patient treated with antineoplastic or medication which may include Methotrexate
13. Hormone therapy started for more than 60 days at the time of inclusion
14. Severe uncontrolled hypertension
15. Patient followed or treated for severe or unstable angina, or having presented a myocardial infarction in the 6 months preceding the randomization
16. Patient on immunosuppressant
17. Patient with known hypersensitivity to gadoteric acid, meglumine or any drug containing gadolinium
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04909294
Study Brief:
Protocol Section:
NCT04909294