TERPS Trial for de Novo Oligometastic Prostate Cancer

• ClinicalTrials.gov Identifier: NCT05223803
• Recruitment Status: Recruiting
• First Posted: February 4, 2022
• Last Update Posted: August 1, 2023
• Sponsor: University of Maryland, Baltimore
• Information provided by (Responsible Party): Department of Radiation Oncology, University of Maryland, Baltimore

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer; Oligometastatic Disease	Radiation: Prostate radiation (XRT); Drug: Systemic Therapy; Radiation: Stereotactic ablative radiation therapy (SABR)	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial
• Actual Study Start Date: October 18, 2022
• Estimated Primary Completion Date: July 2026
• Estimated Study Completion Date: July 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: 2 years ]
   Cross-over to the SABR MDT is allowed following failure.

Secondary Outcome Measures :

1. To determine the number of participants with toxicities related to SABR MDT in patients with de novo oligometastatic disease [ Time Frame: 5 years ]
   Adverse events will be assessed at baseline, on treatment visit, and follow-up visit.
2. To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease. [ Time Frame: 1 year ]
3. To assess time to progression [ Time Frame: 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).
4. Quality of life assessed through EPIC tool utilizing patient scores in each function group following completion of SABR MDT. [ Time Frame: 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).

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Phuoc Tran, MD; 410-369-5200; Phuoc.Tran@umm.edu

Contact: Nicole Helie; 410-328-6304; nicole.helie@umm.edu

Locations

United States, Maryland

Maryland Proton Treatment Center; Recruiting

Baltimore, Maryland, United States, 21201

Contact: Nicole Helie 410-328-6304 nicole.helie@umm.edu

UMMC; Recruiting

Baltimore, Maryland, United States, 21201

Contact: Nicole Helie 410-328-6304 nicole.helie@umm.edu

Upper Chesapeake Health; Not yet recruiting

Bel Air, Maryland, United States, 21014

Contact: Lalicia Roman 443-643-1877 lalicia.roman@umm.edu

Central Maryland Radiation Oncology; Recruiting

Columbia, Maryland, United States, 21044

Contact: Caitlin Eggleston 410-328-7586 caitlineggleston@umm.edu

Baltimore Washington Medical Center; Recruiting

Glen Burnie, Maryland, United States, 21061

Contact: Pilar Strycula, RN, BSN 410-553-8110 Pstrycula@umm.edu

Sponsors and Collaborators

University of Maryland, Baltimore

More Information

• Responsible Party: Department of Radiation Oncology, Principal Investigator, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT05223803
• Other Study ID Numbers: HP-00098826
• First Posted: February 4, 2022
• Last Update Posted: August 1, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases