TERPS Trial for de Novo Oligometastic Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This research is being done to determine if we can improve the outcome of prostate cancer patients who have failed primary treatment - surgery or local radiation to the prostate - and have three or fewer bone or soft tissue metastases.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland, Baltimore

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.