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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT05269550
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years of age
* Histologically confirmed carcinoma of the prostate
* High-intermediate risk or high risk as defined by NCCN criteria:
* High intermediate: 2 or 4 intermediate risk factors (T2B-T2C, Gleason GG 2 or 3, PSA 10-20) or GG 3 or intermediate risk with equal or \>50% biopsy core involvement
* High-risk: one of T3a, Gleason GG 4 or 5, or PSA \>20 ng/ml
* Very-high risk: one of primary Gleason Pattern 5, \>4 cores Grade Group 4 or 5, clinical T3b, or more than 1 high-risk feature
* Conventional imaging (bone scan and abdominal pelvic computed tomography) negative for extra-pelvic nodal, skeletal or visceral metastases
* Willing to give informed consent to participate in this clinical trial
* Able and willing to complete EPIC questionnaires
Exclusion Criteria:
* Prior prostate cancer treatment (apart from prior 5-alpha reductase inhibitor treatment); androgen deprivation therapy prior to enrollment or treatment planning not permitted
* Men with clinical T4 disease are excluded
* Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
* Contraindication to prostate MRI (i.e. non0compatible stent, pacemaker, prosthesis, etc.)
* Contraindication to use of PSMA PET agent PSMA 1007 due to intolerance or allergy
* Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
* Diagnosis of bleeding diathesis
* Poor baseline urinary function defined as a score of 5 ("big problem") on question 5 of the EPIC 26 (Overall, how big a problem has your urinary function been for you during the last 4 weeks?)
* Definitive extra-pelvic nodal or distant metastatic disease on conventional staging investigations
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05269550
Study Brief:
Protocol Section:
NCT05269550