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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Oligometastatic Disease
• Intervention / Treatment: Radiation: Prostate radiation (XRT); Drug: Systemic Therapy; Radiation: Stereotactic ablative radiation therapy (SABR)

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 Type: Interventional
• Enrollment (Estimated): 122
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Phuoc Tran, MD; Phone Number: 410-369-5200; Email: Phuoc.Tran@umm.edu
• Study Contact Backup: Name: Nicole Helie; Phone Number: 410-328-6304; Email: nicole.helie@umm.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • Maryland Proton Treatment Center
      • Contact: Nicole Helie; Phone Number: 410-328-6304; Email: nicole.helie@umm.edu
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • UMMC
      • Contact: Nicole Helie; Phone Number: 410-328-6304; Email: nicole.helie@umm.edu
    • Bel Air, Maryland, United States, 21014
      • Not yet recruiting
      • Upper Chesapeake Health
      • Contact: Lalicia Roman; Phone Number: 443-643-1877; Email: lalicia.roman@umm.edu
    • Columbia, Maryland, United States, 21044
      • Recruiting
      • Central Maryland Radiation Oncology
      • Contact: Caitlin Eggleston; Phone Number: 410-328-7586; Email: caitlineggleston@umm.edu
    • Glen Burnie, Maryland, United States, 21061
      • Recruiting
      • Baltimore Washington Medical Center
      • Contact: Pilar Strycula, RN, BSN; Phone Number: 410-553-8110; Email: Pstrycula@umm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Best systemic therapy (BST) + primary prostate radiation (XRT)	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.
Active Comparator: BST + XRT + SABR metastasis-directed therapy (MDT)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the number of participants with toxicities related to SABR MDT in patients with de novo oligometastatic disease	Adverse events will be assessed at baseline, on treatment visit, and follow-up visit.	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	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).	5 years
Quality of life assessed through EPIC tool utilizing patient scores in each function group following completion of SABR MDT.	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).	5 years

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HP-00098826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes