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Radiation Therapy

Radiotherapy + Systemic Therapy for Oligometastatic Prostate Cancer

Phase 2

Recruiting

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing whether a new drug can help prostate cancer patients who have failed other treatments and have 3 or fewer bone or soft tissue metastases.

Who is the study for?

This trial is for prostate cancer patients who've had surgery or local radiation but now have up to three new bone or soft tissue metastases, with at least one in the bone. They should understand and consent to the study, have a life expectancy of over a year, be able to lie flat for scans and treatment, not be on other investigational drugs, and not have castration-resistant cancer.Check my eligibility

What is being tested?

The TERPS Trial is testing if adding stereotactic ablative radiation therapy (SABR) to systemic therapy improves outcomes in prostate cancer patients with limited metastatic spread after primary treatment failure. It targets those with three or fewer recent metastases.See study design

What are the potential side effects?

Potential side effects include typical reactions from radiation like skin irritation, fatigue, digestive issues; systemic therapy may cause immune-related effects, changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have 1-3 new bone or soft tissue cancer spots, with at least one in the bone, found in the last 6 months.

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My cancer diagnosis was confirmed through tissue examination.

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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.

Secondary outcome measures

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

To assess time to progression

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

+1 more

Trial Design

2Treatment groups

Active Control

Group I: Best systemic therapy (BST) + primary prostate radiation (XRT)Active Control2 Interventions

Group II: BST + XRT + SABR metastasis-directed therapy (MDT)Active Control3 Interventions

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,534 Total Patients Enrolled

12 Trials studying Prostate Cancer

477 Patients Enrolled for Prostate Cancer

Media Library

Prostate radiation (XRT) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05223803 — Phase 2

Prostate Cancer Research Study Groups: Best systemic therapy (BST) + primary prostate radiation (XRT), BST + XRT + SABR metastasis-directed therapy (MDT)

Prostate Cancer Clinical Trial 2023: Prostate radiation (XRT) Highlights & Side Effects. Trial Name: NCT05223803 — Phase 2

Prostate radiation (XRT) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05223803 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some risks associated with BST + XRT + SABR MDT?

"There is some data supporting safety, but none yet confirming efficacy, so we have given it a score of 2."

Answered by AI

At how many locations is this trial currently underway?

"To make it more convenient for participants, this trial is being conducted in 5 locations which include Columbia, Bel Air and Glen Burnie. There are also 5 other clinics running this study."

Answered by AI

Are we still able to sign patients up for this research project?

"This is current information. The clinical trial was posted on October 3rd, 2020 and updated October 10th, 2020 according to the data available on clinicaltrials.gov."

Answered by AI

How many people are currently enrolled in this trial?

"According to the latest update on clinicaltrials.gov, this trial is still actively looking for patients. The trial was originally posted on October 3rd, 2020 and was updated as recently as October 10th, 2020. There are 5 sites currently enrolling 122 participants in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TERPS Trial for de Novo Oligometastic Prostate Cancer

Department of Radiation Oncology 2022. "TERPS Trial for de Novo Oligometastic Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05223803.