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PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer

NCT06392295 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-06-15

No results posted yet for this study

Summary

The purpose of this prostate cancer research study is to learn about:

1. Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen suppression therapy;
2. Preserving quality of life after radiation therapy;
3. Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans to evaluate and manage disease progression.

Conditions

  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Hormone Sensitive Prostate Cancer

Interventions

RADIATION

Para Aortic Radiation Therapy: Photon Therapy

Participants will undergo five weeks of PA-RT daily, for up to 30 minutes per day for 25 days, Monday through Friday, consisting of a total dose of 50 grays (Gys) delivered in 25 fractions to the Clinical Tumor Volume (CTV).

RADIATION

Para Aortic Radiation Therapy: Proton Therapy

Participants will undergo five weeks of PA-RT daily, for up to 30 minutes per day for 25 days, Monday through Friday, consisting of a total dose of 60 to 65 Gys delivered in 25 fractions to the Gross Tumor Volume (GTVn).

DRUG

Androgen Deprivation Therapy

Androgen deprivation therapy will be administered as per standard of care.

DRUG

Androgen Receptor Signaling Inhibitor

Androgen receptor signaling inhibitor (ARSI) will be administered as per standard of care.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Benjamin J Rich, MD · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-03
Primary Completion
2027-08-01
Completion
2029-08-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06392295 on ClinicalTrials.gov