Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial
Overview
- Phase
- Phase 2
- Intervention
- Stereotactic ablative radiation therapy (SABR)
- Conditions
- Prostate Cancer
- Sponsor
- University of Maryland, Baltimore
- Enrollment
- 122
- Locations
- 9
- Primary Endpoint
- To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT.
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief 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.
Detailed Description
This study will compare the effects, good and/or bad, of using the standard of care treatment (systemic therapy + primary prostate radiation) compared to standard of care treatment plus stereotactic ablative radiation therapy (SABR) to metastatic lesions for prostate patients. The researchers are also trying to learn if the addition of SABR will affect recurrence rates. Presence of circulating tumor cells, gut bacteria, and quality of life will be assessed for both groups.
Investigators
Department of Radiation Oncology
Principal Investigator
University of Maryland, Baltimore
Eligibility Criteria
Inclusion Criteria
- •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.
- •CT or MRI scan within 6 months of enrollment
- •Bone scan within 6 months of enrollment
- •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)
- •Histologic confirmation of malignancy (primary or metastatic tumor).
- •Patient may have had prior systemic therapy and/or ADT associated with treatment within 9-months of enrollment.
- •PSA \> 0.5 but \<
- •Patient must be ≥ 18 years of age.
- •Patient must have a life expectancy ≥ 12 months.
- •Patient must have an ECOG performance status ≤
Exclusion Criteria
- •Castration-resistant prostate cancer (CRPC).
- •Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy
- •Spinal cord compression or impending spinal cord compression.
- •Suspected pulmonary and/or liver metastases (greater \>10 mm in largest axis).
- •Patient receiving any other investigational agents.
- •Inability to receive any form of systemic therapy in the opinion of a treating medical oncologist .
- •Unable to lie flat during or tolerate PET/MRI, PET/CT or SABR.
- •No radiographical evidence of cranial metastasis.
- •Refusal to sign informed consent.
Arms & Interventions
BST + XRT + SABR metastasis-directed therapy (MDT)
Intervention: Stereotactic ablative radiation therapy (SABR)
Best systemic therapy (BST) + primary prostate radiation (XRT)
Intervention: Prostate radiation (XRT)
Best systemic therapy (BST) + primary prostate radiation (XRT)
Intervention: Systemic Therapy
BST + XRT + SABR metastasis-directed therapy (MDT)
Intervention: Prostate radiation (XRT)
BST + XRT + SABR metastasis-directed therapy (MDT)
Intervention: Systemic Therapy
Outcomes
Primary Outcomes
To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT.
Time Frame: 2 years
Cross-over to the SABR MDT is allowed following failure.
Secondary Outcomes
- To determine the number of participants with toxicities related to SABR MDT in patients with de novo oligometastatic disease(5 years)
- To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease.(1 year)
- Quality of life assessed through EPIC tool utilizing patient scores in each function group following completion of SABR MDT.(5 years)
- To assess time to progression(5 years)