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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT01956058
Eligibility Criteria:
Inclusion Criteria:
1. localized prostate adenocarcinoma who presented as baseline characteristics: PSA ≤ 20ng/ml (with a rate of increase \<2ng/ml/an in the 18 months preceding the biopsy diagnosis), Gleason score ≤ 7 and T1c to t2c.
2. Indication of brachytherapy remedial validated
3. Prior treatment of prostatic adenocarcinoma by radiotherapy or brachytherapy
4. Recurrence histologically proven by biopsy within ≥ 24 months after the end of the first radiotherapy or brachytherapy
5. Re-rise of PSA biochemical assays on three successive but with a PSA recurrence \<10ng/ml
6. Patient over 18 years
7. WHO status 0 or 1
8. Information informed and signed by the patient or his legal representative
Exclusion Criteria:
1. Volume Prostate\> 50 cm3
2. proctitis and / or radiation cystitis grade ≥ 2 at the time of inclusion
3. Initial rT3a-RT4 at the time of recurrence (clinical or MRI)
4. Gleason score ≥ 8 (if it can be established after central review) at the time of recurrence
5. lymph node and bone metastases
6. invaded the seminal vesicles (diagnosed by MRI or biopsy)
7. History of prostatectomy, TURP, or cryoablation Ablatherm ®
8. node lymphadenectomy for "restaging" before salvage treatment
9. IPSS\> 12
10. Getting Started with hormone therapy since the diagnosis of recurrence
11. History of cancer within 5 years prior to entry into the trial other than basal cell skin
12. Patient already included in another clinical trial with an experimental molecule,
13. Persons deprived of liberty or under supervision (including guardianship)
14. Inability to undergo medical monitoring test for geographical, social or psychological reasons.
15. Contraindications to performing an MRI (metal prosthetic material, claustrophobia, pacemaker ...)
16. Patient anticoagulant Plavix or under
17. History of inflammatory bowel disease such as ulcerative colitis or Crohn's disease
18. History of rectal surgery
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
19 Years
Study:
NCT01956058
Study Brief:
Protocol Section:
NCT01956058