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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07348367
Eligibility Criteria:
Inclusion Criteria:
* Prostate cancer patients receiving treatment at Henry Ford Health from the investigator or co-investigator who opt for surgery.
* Prostate-specific antigen (PSA) ≤20 ng/mL
* Clinical stage ≤cT2
* Dominant unilateral lesion with Gleason ≤4+3 on biopsy
* No Gleason ≥4 contralaterally
* Preoperative SHIM score ≥17 (with or without phosphodiesterase-5 inhibitor use)
Exclusion Criteria:
* • Androgen deprivation therapy within 6 months.
* Nodal positive disease
* Metastatic disease
* Prior prostate cancer therapy (e.g., radiation, HIFU).
* Significant comorbidities precluding surgery or life expectancy \<5 years as defined by the Prostate Cancer Comorbidity Index \[5\].
* Any previous cancer diagnosis.
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT07348367
Study Brief:
Protocol Section:
NCT07348367