TERPS Trial for de Novo Oligometastic Prostate Cancer

Phase 2

Recruiting

• Conditions: Prostate Cancer; Oligometastatic Disease
• Interventions: Radiation: Prostate radiation (XRT); Drug: Systemic Therapy; Radiation: Stereotactic ablative radiation therapy (SABR)

• Registration Number: NCT05223803
• Lead Sponsor: University of Maryland, Baltimore

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.

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-02-04
• Study Start: 2022-10-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2026-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Best systemic therapy (BST) + primary prostate radiation (XRT)	Prostate radiation (XRT)	-
Best systemic therapy (BST) + primary prostate radiation (XRT)	Systemic Therapy	-
BST + XRT + SABR metastasis-directed therapy (MDT)	Stereotactic ablative radiation therapy (SABR)	-
BST + XRT + SABR metastasis-directed therapy (MDT)	Prostate radiation (XRT)	-
BST + XRT + SABR metastasis-directed therapy (MDT)	Systemic Therapy	-

Primary Outcome Measures

Name	Time	Method
To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT.	2 years	Cross-over to the SABR MDT is allowed following failure.

Secondary Outcome Measures

Name	Time	Method
To determine the number of participants with toxicities related to SABR MDT in patients with de novo oligometastatic disease	5 years	Adverse events will be assessed at baseline, on treatment visit, and follow-up visit.
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	EPIC quality of life tool will be used to assess quality of life following treatment. This survey will be completed at baseline and during follow-up visits. Averages will be taken for each section in the survey (Urinary Function, Bowel Function, Sexual Function, and Hormonal function).
To assess time to progression	5 years	Progression will be assessed for time to locoregional progression, time to distant progression, time to new metastasis, radiographic progression-free survival and duration of response after randomization to best systemic therapy (BST) and primary prostate radiation (XRT) versus BST, XRT and stereotactic ablative radiation therapy (SABR) metastasis-directed therapy (MDT).

Trial Locations

Locations (9)

UC San Diego Moores Cancer Center; 🇺🇸 La Jolla, California, United States

Sidney Kimmel Cancer Center at Jefferson Health; 🇺🇸 Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Bon Secours Cancer Institute at St. Francis; 🇺🇸 Midlothian, Virginia, United States

Maryland Proton Treatment Center; 🇺🇸 Baltimore, Maryland, United States

UMMC; 🇺🇸 Baltimore, Maryland, United States

Upper Chesapeake Health; 🇺🇸 Bel Air, Maryland, United States

Central Maryland Radiation Oncology; 🇺🇸 Columbia, Maryland, United States

Baltimore Washington Medical Center; 🇺🇸 Glen Burnie, Maryland, United States