NCT05423860 · RECRUITING
Phase I Human Analytics (HALO) Study
This is an observational study, so nobody receives a drug or treatment. Researchers are collecting health data and biomarkers to build better ways to spot heart disease, cancer, dementia and brain injury early, including machine learning risk scores. The phase is listed as unspecified. The eligibility details shown describe men with early prostate cancer.
Eligibility criteria
Inclusion Criteria: Treatment Naïve patients: * Male, 45 years of age or older. * Diagnosis of prostate adenocarcinoma. * Clinical stage T1c or T2a. * Gleason score of 7 (3+4 or 4+3) or less. * Three or fewer biopsy cores with prostate cancer. * PSA density not exceeding 0.375. * One, two, or three tumor suspicious regions identified on multiparametric MRI. * Negative radiographic indication of extra-capsular extent. * Karnofsky performance status of at least 70. * Estimated survival of 5 years or greater, as determined by treating physician. * Tolerance for anesthesia/sedation. * Ability to give informed consent. * At least 6 weeks since any previous prostate biopsy. * MR-guided biopsy confirmation of one or more MRI-visible prostate lesion(s) with Gleason score of 7 (3+4 or 4+3) or less. Salvage candidates will be accepted upon physician referral. Exclusion Criteria: * Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI. * Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater * History of other primary non-skin malignancy within previous three years. * Diabetes * Smoker
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2022-10-14