Prostate CancerPhase 2NCT05223803
TERPS Trial for de Novo Oligometastic Prostate Cancer
A Phase 2 study testing Prostate radiation (XRT), Systemic Therapy and Stereotactic ablative radiation therapy (SABR) in people with Prostate Cancer and Oligometastatic Disease, run by University of Maryland, Baltimore at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Oligometastatic Disease
- What is being tested?
- Prostate radiation (XRT), Systemic Therapy and Stereotactic ablative radiation therapy (SABR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Oct 2022to 31 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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 .
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- Unable to lie flat during or tolerate PET/MRI, PET/CT or SABR.
- No radiographical evidence of cranial metastasis.
- Refusal to sign informed consent.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
Nicole Helie, 410-328-6304, nicole.helie@umm.edu
- Recruiting
UMMC
Baltimore, Maryland, 21201
Nicole Helie, 410-328-6304, nicole.helie@umm.edu
- Recruiting
Upper Chesapeake Health
Bel Air, Maryland, 21014
Lalicia Roman, 443-643-1877, lalicia.roman@umm.edu
- Recruiting
Central Maryland Radiation Oncology
Columbia, Maryland, 21044
Caitlin Eggleston, 410-328-7586, caitlineggleston@umm.edu
- Recruiting
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
Pilar Strycula, RN, BSN, 410-553-8110, Pstrycula@umm.edu
- Recruiting
KU Medical Center- Cancer Center
Kansas City, Kansas, 66160
Xinglei Shen, MD, 913-588-1227, xshen@kumc.edu
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Tyler Seibert, MD, PhD, 858-822-6040, tseibert@health.ucsd.edu
- Recruiting
Bon Secours Cancer Institute at St. Francis
Midlothian, Virginia, 23114
Joseph Pennington, MD, 804-266-7762, joseph_pennington@bshsi.org
- Recruiting
Sidney Kimmel Cancer Center at Jefferson Health
Philadelphia, Pennsylvania, 19107
Jessie DiNome, MD, 215-955-8874, Jessie.DiNome@jefferson.edu
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Adam Olson, MD, 412-623-6720, olsonac2@upmc.edu
About this study
Official title: 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 see if we can improve the outcome of prostate cancer patients who present with metastatic lesions at initial diagnosis.
Read the 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
- Being tested
- Prostate radiation (XRT), Systemic Therapy, Stereotactic ablative radiation therapy (SABR)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate radiation (XRT)Radiation
Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.
Systemic TherapyDrug
All systemic therapy is provided as best prescribed for patient per their medical oncologist.
Stereotactic ablative radiation therapy (SABR)Radiation
SABR is delivered to those randomized to Arm 2.
| Study group | Role | What they receive |
|---|---|---|
| Best systemic therapy (BST) + primary prostate radiation (XRT) | Active comparator | Not described Receives: Radiation: Prostate radiation (XRT); Drug: Systemic Therapy |
| BST + XRT + SABR metastasis-directed therapy (MDT) | Active comparator | Not described Receives: Radiation: Prostate radiation (XRT); Drug: Systemic Therapy; Radiation: Stereotactic ablative radiation therapy (SABR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
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.
Measured: 5 years
To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease.
Measured: 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).
Measured: 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).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start18 Oct 2022
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223803
- Sponsor's protocol ID
- HP-00098826
- Status last verified
- May 2026
- First submitted
- 10 Jan 2022
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial
- ClinicalTrials.gov ID
- NCT05223803
- Acronym / sponsor ID
- HP-00098826
- Conditions
- Prostate Cancer, Oligometastatic Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best systemic therapy (BST) + primary prostate radiation (XRT) | Active comparator | Radiation: Prostate radiation (XRT), Drug: Systemic Therapy |
| BST + XRT + SABR metastasis-directed therapy (MDT) | Active comparator | Radiation: Prostate radiation (XRT), Drug: Systemic Therapy, Radiation: Stereotactic ablative radiation therapy (SABR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate radiation (XRT)Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol. | Radiation | BST + XRT + SABR metastasis-directed therapy (MDT), Best systemic therapy (BST) + primary prostate radiation (XRT) |
| Systemic TherapyAll systemic therapy is provided as best prescribed for patient per their medical oncologist. | Drug | BST + XRT + SABR metastasis-directed therapy (MDT), Best systemic therapy (BST) + primary prostate radiation (XRT) |
| Stereotactic ablative radiation therapy (SABR)SABR is delivered to those randomized to Arm 2. | Radiation | BST + XRT + SABR metastasis-directed therapy (MDT) |
Primary outcome
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.
4 secondary outcomes
To determine the number of participants with toxicities related to SABR MDT in patients with de novo oligometastatic disease
Time frame: 5 years
To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease.
Time frame: 1 year
To assess time to progression
Time frame: 5 years
Quality of life assessed through EPIC tool utilizing patient scores in each function group following completion of SABR MDT.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prostate radiation (XRT), Systemic Therapy and Stereotactic ablative radiation therapy (SABR) in people with Prostate Cancer and Oligometastatic Disease, run by University of Maryland, Baltimore at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zaker Rana, MD (410-369-5200, zaker.rana@umm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.