NCT05223803 TERPS Trial for de Novo Oligometastic Prostate Cancer
| NCT ID | NCT05223803 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Maryland, Baltimore |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 122 participants |
| Start Date | 2022-10-18 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 122 participants in total. It began in 2022-10-18 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This research is being done to see if we can improve the outcome of prostate cancer patients who present with metastatic lesions at initial diagnosis.
Eligibility Criteria
Inclusion Criteria: 1. Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are seen on imaging. Up to five lesions are allowed on advanced functional imaging such as fluciclovine (Axumin), choline or PSMA PET-CT scan. 1. CT or MRI scan within 6 months of enrollment 2. Bone scan within 6 months of enrollment 3. Fluciclovine (Axumin), choline, or PSMA PET-CT scan within 6 months of enrollment (PET-CT scan is reasonable for study entry imaging as an alternative to CT/MRI scan and bone scan) 2. Histologic confirmation of malignancy (primary or metastatic tumor). 3. Patient may have had prior systemic therapy and/or ADT associated with treatment within 9-months of enrollment. 4. PSA \> 0.5 but \<100. 5. Patient must be ≥ 18 years of age. 6. Patient must have a life expectancy ≥ 12 months. 7. Patient must have an ECOG performance status ≤ 2. 8. Patient must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 1. Castration-resistant prostate cancer (CRPC). 2. Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy 3. Spinal cord compression or impending spinal cord compression. 4. Suspected pulmonary and/or liver metastases (greater \>10 mm in largest axis). 5. Patient receiving any other investigational agents. 6. Inability to receive any form of systemic therapy in the opinion of a treating medical oncologist . 7. Unable to lie flat during or tolerate PET/MRI, PET/CT or SABR. 8. No radiographical evidence of cranial metastasis. 9. Refusal to sign informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05223803 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05223803 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05223803 currently recruiting?
Yes, NCT05223803 is actively recruiting participants. Contact the research team at zaker.rana@umm.edu for enrollment information.
Where is the NCT05223803 trial being conducted?
This trial is being conducted at La Jolla, United States, Kansas City, United States, Baltimore, United States, Baltimore, United States and 6 additional locations.
Who is sponsoring the NCT05223803 clinical trial?
NCT05223803 is sponsored by University of Maryland, Baltimore. The trial plans to enroll 122 participants.
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