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:
NCT03160794
Eligibility Criteria:
* ECOG performance status of 0-2
* Absence of significant comorbidities rendering patient nor suitable for curative ablative approaches
* No history of non-skin malignancy
* Histological evidence of prostate adenocarcinoma on previous radical prostatectomy.
* No use of any form of hormonal therapy in the previous 12 months, or intention to start HT at time of enrollment.
* Normal serum testosterone level ascertained within 4-6 weeks of enrollment
* Absence of known metastatic disease
* Radiological studies without evidence of regional or distant metastases: CT abdomen-pelvis and bone scan within previous 3 months
* Able to lie supine at least 60 minutes to comply with imaging and treatment.
* Absence of impaired renal function (calculated GFR \> 30mL/min)
* Absence of sickle cell disease or other hemoglobinopathies
* No other medical conditions deemed by the PI to make patient ineligible for PET/MR scanning or SABR
No contraindications to MRI:
* Subject must weigh \<136kg (scanner weight limit)
* Subject must not have pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices not compatible with MRI
* Prior anaphylactic reaction to gadolinium
Rising PSA after maximal local therapies (radical prostatectomy and either adjuvant or salvage radiotherapy):
* Three documented PSA rises, at least 1 month apart from post radiotherapy.
* PSA value \>0.1 and \< 3 ng/mL, within 4-6 weeks of enrollment
* No use of any forms of ADT in the previous 12 months nor contemplated to be used at time of study enrollment. Salvage ADT to be started when PSA reaches a value of 6.0ng/ml or greater.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03160794
Study Brief:
Protocol Section:
NCT03160794