Improving treatment for prostate cancer with metastases at diagnosis

Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial

This study is testing if adding a special type of radiation therapy to standard treatment helps men with newly diagnosed prostate cancer that has spread feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University of Maryland, Baltimore (Academic / other)
• Drugs / interventions: radiation
• Locations: 9 sites (La Jolla, California and 8 other locations)
• Trial ID: NCT05223803 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of adding stereotactic ablative radiation therapy (SABR) to the standard treatment regimen for prostate cancer patients with newly diagnosed oligometastatic disease. Participants will receive either the standard of care treatment, which includes systemic therapy and primary prostate radiation, or the same treatment plus SABR targeting metastatic lesions. The study will also assess the impact of these treatments on recurrence rates, circulating tumor cells, gut bacteria, and quality of life. The trial is designed to provide insights into optimizing treatment strategies for this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with asymptomatic metastatic prostate cancer and specific imaging-confirmed lesions.

Not a fit: Patients with extensive metastatic disease or those with a life expectancy of less than 12 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes and reduced recurrence rates for patients with oligometastatic prostate cancer.

How similar studies have performed: Other studies have shown promise in using SABR for metastatic lesions, suggesting potential for success in this approach.

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.

Where this trial is running

La Jolla, California and 8 other locations

• UC San Diego Moores Cancer Center — La Jolla, California, United States (Recruiting)
• Maryland Proton Treatment Center — Baltimore, Maryland, United States (Recruiting)
• Ummc — Baltimore, Maryland, United States (Recruiting)
• Upper Chesapeake Health — Bel Air, Maryland, United States (Not_yet_recruiting)
• Central Maryland Radiation Oncology — Columbia, Maryland, United States (Recruiting)
• Baltimore Washington Medical Center — Glen Burnie, Maryland, United States (Recruiting)
• Sidney Kimmel Cancer Center at Jefferson Health — Philadelphia, Pennsylvania, United States (Recruiting)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
• Bon Secours Cancer Institute at St. Francis — Midlothian, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Phuoc Tran, MD

Conditions Prostate Cancer; Oligometastatic Disease