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TERPS Trial for de Novo Oligometastic Prostate Cancer

Primary Purpose

Prostate Cancer, Oligometastatic Disease

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Prostate radiation (XRT)

Systemic Therapy

Stereotactic ablative radiation therapy (SABR)

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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)
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

Exclusion Criteria:

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.

Sites / Locations

Maryland Proton Treatment CenterRecruiting
UMMCRecruiting
Upper Chesapeake Health
Central Maryland Radiation OncologyRecruiting
Baltimore Washington Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Best systemic therapy (BST) + primary prostate radiation (XRT)

BST + XRT + SABR metastasis-directed therapy (MDT)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease.

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).

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).

Full Information

NCT ID

NCT05223803

First Posted

January 10, 2022

Last Updated

July 28, 2023

Sponsor

University of Maryland, Baltimore

1. Study Identification

Unique Protocol Identification Number

NCT05223803

Brief Title

TERPS Trial for de Novo Oligometastic Prostate Cancer

Official Title

Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 18, 2022 (Actual)

Primary Completion Date

July 2026 (Anticipated)

Study Completion Date

July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Oligometastatic Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Best systemic therapy (BST) + primary prostate radiation (XRT)

Arm Type

Active Comparator

Arm Title

BST + XRT + SABR metastasis-directed therapy (MDT)

Arm Type

Active Comparator

Intervention Type

Radiation

Intervention Name(s)

Prostate radiation (XRT)

Intervention Description

Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.

Intervention Type

Drug

Intervention Name(s)

Systemic Therapy

Intervention Description

All systemic therapy is provided as best prescribed for patient per their medical oncologist.

Intervention Type

Radiation

Intervention Name(s)

Stereotactic ablative radiation therapy (SABR)

Intervention Description

SABR is delivered to those randomized to Arm 2.

Primary Outcome Measure Information:

Title

To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT.

Description

Cross-over to the SABR MDT is allowed following failure.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

To determine the number of participants with toxicities related to SABR MDT in patients with de novo oligometastatic disease

Description

Adverse events will be assessed at baseline, on treatment visit, and follow-up visit.

Time Frame

5 years

Title

To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease.

Time Frame

1 year

Title

To assess time to progression

Description

Time Frame

5 years

Title

Quality of life assessed through EPIC tool utilizing patient scores in each function group following completion of SABR MDT.

Description

Time Frame

5 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Phuoc Tran, MD

Phone

410-369-5200

Phuoc.Tran@umm.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Nicole Helie

Phone

410-328-6304

nicole.helie@umm.edu

Facility Information:

Facility Name

Maryland Proton Treatment Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicole Helie

Phone

410-328-6304

nicole.helie@umm.edu

Facility Name

UMMC

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicole Helie

Phone

410-328-6304

nicole.helie@umm.edu

Facility Name

Upper Chesapeake Health

City

Bel Air

State/Province

Maryland

ZIP/Postal Code

21014

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lalicia Roman

Phone

443-643-1877

lalicia.roman@umm.edu

Facility Name

Central Maryland Radiation Oncology

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21044

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caitlin Eggleston

Phone

410-328-7586

caitlineggleston@umm.edu

Facility Name

Baltimore Washington Medical Center

City

Glen Burnie

State/Province

Maryland

ZIP/Postal Code

21061

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pilar Strycula, RN, BSN

Phone

410-553-8110

Pstrycula@umm.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

TERPS Trial for de Novo Oligometastic Prostate Cancer

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