NCT05223803

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Prostate Cancer
• Oligometastatic Disease

Interventions

Type	Name	Description
RADIATION	Prostate radiation (XRT)	Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.
DRUG	Systemic Therapy	All systemic therapy is provided as best prescribed for patient per their medical oncologist.
RADIATION	Stereotactic ablative radiation therapy (SABR)	SABR is delivered to those randomized to Arm 2.

Timeline

• Start date: 2022-10-18
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2022-02-04
• Last updated: 2025-11-10

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study