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New treatment option for Prostate Cancer
Official title TERPS Trial for de Novo Oligometastic Prostate Cancer
ClinicalTrials.gov ID: NCT05223803
What this study is testing
What is Systemic Therapy?
Systemic Therapy is an investigational medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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)...
- 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...
- Histologic confirmation of malignancy (primary or metastatic tumor).
You likely can't join if
- 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 .
See the full eligibility 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Bel Air, Maryland, United States
- Columbia, Maryland, United States
- Glen Burnie, Maryland, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Midlothian, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Kansas City, Kansas, United States; Baltimore, Maryland, United States; Bel Air, Maryland, United States; Columbia, Maryland, United States; Glen Burnie, Maryland, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.