TERPS Trial for De Novo Oligometastic Prostate Cancer

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Jan 24, 2022

Keywords

ClinConnect Summary

The TERPS Trial is a research study aimed at improving the outcomes for men diagnosed with oligometastatic prostate cancer, which means they have a few cancer spots that have spread to other parts of the body, like bones or soft tissues, but are not widespread. This trial is looking for participants who have one to three of these metastatic tumors that have been detected through imaging within the last six months. To qualify, men must be at least 18 years old, have a certain level of prostate-specific antigen (PSA) in their blood, and have a life expectancy of at least a year.

Participants in the trial can expect to undergo various imaging tests to confirm their condition and may receive additional treatments. The study is currently recruiting and focuses on men aged 65 to 74 who can understand the study details and agree to participate. It’s important to note that certain conditions, like having advanced prostate cancer that does not respond to treatment, may disqualify someone from joining. Overall, the TERPS Trial aims to find more effective ways to treat prostate cancer at this stage of the disease.

Gender

MALE

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.