TERPS Trial for de Novo Oligometastic Prostate Cancer
Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial
1 other identifier
interventional
122
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Oct 2022
Typical duration for phase_2 prostate-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2022
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedStudy Start
First participant enrolled
October 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
November 10, 2025
November 1, 2025
3.8 years
January 10, 2022
November 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT.
Cross-over to the SABR MDT is allowed following failure.
2 years
Secondary Outcomes (4)
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
To assess time to progression
5 years
Quality of life assessed through EPIC tool utilizing patient scores in each function group following completion of SABR MDT.
5 years
Study Arms (2)
Best systemic therapy (BST) + primary prostate radiation (XRT)
ACTIVE COMPARATORBST + XRT + SABR metastasis-directed therapy (MDT)
ACTIVE COMPARATORInterventions
Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.
All systemic therapy is provided as best prescribed for patient per their medical oncologist.
SABR is delivered to those randomized to Arm 2.
Eligibility Criteria
You may qualify if:
- 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 \<100.
- Patient must be ≥ 18 years of age.
- Patient must have a life expectancy ≥ 12 months.
- Patient must have an ECOG performance status ≤ 2.
- Patient must have the ability to understand and the willingness to sign a written informed consent document
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Maryland Proton Treatment Center
Baltimore, Maryland, 21201, United States
UMMC
Baltimore, Maryland, 21201, United States
Upper Chesapeake Health
Bel Air, Maryland, 21014, United States
Central Maryland Radiation Oncology
Columbia, Maryland, 21044, United States
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061, United States
Sidney Kimmel Cancer Center at Jefferson Health
Philadelphia, Pennsylvania, 19107, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Bon Secours Cancer Institute at St. Francis
Midlothian, Virginia, 23114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 10, 2022
First Posted
February 4, 2022
Study Start
October 18, 2022
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2027
Last Updated
November 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share