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Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer

NCT07325721•Medical University of South Carolina

View on ClinicalTrials.gov

Summary

This study is for adult men with previously untreated high risk, very high risk, or pelvic lymph node positive prostate cancer. The purpose of this study is to evaluate the safety and effectiveness of the combination of two emerging radiation treatment techniques (hypofractionated radiotherapy and microboost technique). Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. There is optional banking of blood and prostate biopsy tissue which will not require extra biopsies. Participation in this study is anticipated to last approximately 6 weeks with follow up every three months for two years then twice yearly for years 3-5.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Provision of signed and dated informed consent form.
•2. Stated willingness to comply with all study procedures and availability for the duration of the study.
•3. Biologically male patients aged 18 years and older.
•4. Ability to receive pelvic radiotherapy and be willing to adhere to the protocol regimen.
•5. Previously untreated prostate cancer (with cytotoxic chemotherapy, cryotherapy, ablative treatment, surgical or radiation therapy). Prior transurethral resection of prostate (TURP) is permitted if 90 days or more prior to the start of radiotherapy.
•6. Localized or locally advanced prostate cancer meeting NCCN criteria for high risk, very high risk or non-metastatic, pelvic lymph node positive defined as having at least one or more of the following:
•1. PSA \>20 ng/mL prior to starting ADT.
•2. cT3a-T4 by digital exam or imaging.
•3. Gleason score of 8-10 (grade group 4 or 5).
•4. Staged as N1M0 by the treating investigator (pelvic lymph node positive, below the aortic bifurcation) based on soft tissue imaging within 120 days prior to registration (may include CT, MRI or PSMA PET/CT, of fluciclovine choline PET/CT).
+11 more criteria

Exclusion Criteria

•1\. Concurrent use of testosterone supplementation unless discontinued by time of registration.
•2\. Definitive radiologic evidence of metastatic disease outside of the pelvic nodes on conventional imaging (bone scan, CT scan, MRI).
•5\. Treatment with another investigational prostate cancer therapy within 12 months.
•6\. Prior total prostatectomy, cryotherapy, high-intensity focused ultrasound, irreversible electroporation, MRI ablation, laser ablation, transurethral ultrasound ablation, aquablation directed towards the prostate for any prostate disease or condition.
•7\. Prior or concurrent invasive pelvic malignancy (except non-melanomatous skin cancer) or lymphomatous or hematogenous malignancy, unless disease free for a minimum of 5 years.
•8\. Any condition that, in the opinion of the investigator, would preclude participation in this study.
•9\. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 90 days prior to registration.
•10\. Inability to undergo implantation of gold fiducial markers or rectal spacer gel.
•11\. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.

Locations (1)

Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, United States

Key Dates

Start Date

February 2, 2026

Primary Completion Date

January 1, 2029

Completion Date

January 1, 2034

Last Updated

February 5, 2026

Enrollment

ESTIMATED participants

Conditions

Prostate CancerProstate Cancer Patients Treated by Radiotherapy

Interventions

Hypofractionated radiation with a microboost

RADIATION

Contacts

Harriet Eldredge-Hindy Eldredge-Hindy, MD

CONTACT

8437926382 eldredge@musc.edu

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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: February 5, 2026Data 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.

View ClinicalTrials.gov Terms and Conditions

Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer

Inclusion Criteria

Exclusion Criteria

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