A Phase 4 Open-Label Multicenter Study of PYLARIFY PET/CT or PET/MRI in Men with Newly Diagnosed Favorable Intermediate Risk (FIR) Prostate Cancer
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
IV
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Contact Us
(410) 955-8964Brief Summary
Subjects with newly diagnosed FIR prostate cancer as determined by SOC clinical staging methods, with or without multiparametric (mp) MRI of the prostate will be screened prior to implementing a treatment strategy.
Eligibility
Inclusion Criteria:
Patients must have the ability to understand and sign an approved informed consent form (ICF)
Patients must have the ability to understand and comply with all protocol requirements
Patients must be ≥ 18 years of age
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Patients with life expectancy of at least 13 months as determined by the investigator
Patients must have confirmed favorable intermediate risk (FIR) adenocarcinoma of the prostate per 2023 NCCN guidelines. FIR risk group confirmation includes all the following:
- 1 intermediate risk factor (cT2b-cT2c or ISUP Grade Group 2 or PSA 10-20 ng/mL)
- ISUP Grade Group 1 or 2
- <50% biopsy cores positive (e.g., <6 of 12 cores)
Note: Date of the prostate biopsy should be no sooner that 2 weeks and no later than 3 months prior to PYLARIFY PET imaging
Exclusion Criteria:
- Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1 (PYLARIFY imaging)
- Previous Prostate cancer treatment including radiation, androgen deprivation therapy, brachytherapy, surgery, prostate ablation, hormonal therapies or investigational therapy
- Known hypersensitivity to the components of PYLARIFY or its analogs
- Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or complete the study
- Patients who have any radiographic evidence of T3, N1 or M1 disease on SOC imaging (if performed)