NCT05223803 · University of Maryland, Baltimore
TERPS Trial for De Novo Oligometastic Prostate Cancer
What this study is about
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.
View original scientific description
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.
Interventions
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.
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.
Time frame: 2 years
Cross-over to the SABR MDT is allowed following failure.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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) 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 m
Where
- La Jolla, California
- Kansas City, Kansas
- Baltimore, Maryland
- Bel Air, Maryland
- Columbia, Maryland
- Glen Burnie, Maryland
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Midlothian, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations