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SBRT for Oligometastatic Castration-Refractory Prostate Cancer | Clinical Trials | Clareo Health

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SBRT for Oligometastatic Castration-Refractory Prostate Cancer

A Phase II Evaluation of SBRT in Oligometastatic Castration-Refractory Prostate Cancer and Immunogenicity of SBRT

NCT02816983•Mayo Clinic

Summary

Castration-resistant prostate cancer patients with rising prostatic specific antigen (PSA) are eligible for this study. 11C-Choline PET/CT will be used to identify metastatic lesions. Patients with \<=3 metastatic lesions will receive stereotactic body radiotherapy (SBRT) as definitive treatment. Blood draws will be taken to monitor the development of anti-prostate cancer immunity

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Patients must be receiving standard of care SBRT as outlined in the Universal Content Management (UCM) Procedure Manual (http://mayocontent.mayo.edu/radoncology/categories/index.html)
•Age ≥ 18 years.
•Metastatic castration-refractory prostate cancer patients with ≤ 3 lesions identified on standard imaging and/or choline PET/CT within 60 days of registration
•Castrate levels of testosterone
•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 (Appendix I).
•Life expectancy \> 6 months

Exclusion Criteria

•Emergent cord compression for spinal metastases
•Severe, active co-morbidity, defined as follows:
•1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
•2. Transmural myocardial infarction within the last 6 months prior to registration
•3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
•4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
•5. Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic disease.
•6. HIV positive with Cluster Differentiation 4 (CD4) count \< 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol.
•7. End-stage renal disease (i.e., on dialysis or dialysis has been recommended).
•Metastases located within 3 cm of the previously irradiated structures:
+5 more criteria

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

March 1, 2016

Primary Completion Date

January 20, 2022

Completion Date

January 20, 2022

Last Updated

August 25, 2022

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

SBRT

RADIATION

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 25, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SBRT for Oligometastatic Castration-Refractory Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC