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:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2025-12-24 @ 3:58 PM
NCT ID:
NCT06027892
Eligibility Criteria:
Inclusion:
* Male patients ≥18 years
* Diagnosis of low- or favorable intermediate-risk prostate adenocarcinoma
* T1-T2c
* Prostate specific antigen \< 20
* Gleason 6 or 7 (3+4)
* Cannot had multiple intermediate-risk factors consistent with unfavorable intermediate risk disease
* Prostate gland \< 60 cc (can include following cytoreductive androgen deprivation)
* International Prostate Symptom Score \< 15 (unaided by a-adrenergic inhibitor or anticholinergic drugs)
Exclusion:
* Unfavorable intermediate-risk disease and above
* Chronic inflammatory bowel condition (IBD, Crohn's disease, Sarcoidosis, Rheumatic disease)
* Chronic immunosuppression
* Contraindications to hydrogel spacer placement
* Contraindications to a prostate MRI
* Any prior prostate cancer treatment
* Prior pelvic radiotherapy
* Previous transurethral resection of the prostate (TURP) within 12 months
* Hip prosthesis
* Prior use of therapeutic androgen deprivation therapy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06027892
Study Brief:
Protocol Section:
NCT06027892