Status:
RECRUITING
Phase I Human Analytics (HALO) Study
Lead Sponsor:
HALO Diagnostics
Collaborating Sponsors:
HALO Affiliate Sites
Conditions:
Cardiovascular Diseases
Cancer
Eligibility:
MALE
45-90 years
Brief Summary
Discover, optimize, standardize, and validate clinical-trial measures and biomarkers used to diagnose and differentiate cardiovascular, oncologic, neurologic, and other diseases and disorders. Specifi...
Detailed Description
Electronic medical records contain data that may indicate increased risk for certain diseases and disorders, but clinicians cannot easily discern the subtle patterns required to change their diagnosti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2037
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT05423860
Start Date
March 16 2022
End Date
March 1 2037
Last Update
October 14 2022
Active Locations (1)
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1
Desert Medical Imaging
Indian Wells, California, United States, 92210