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PSMA-Directed Radiation for Oligorecurrent Prostate Cancer

This study is for men with prostate cancer that has returned in a limited way (oligorecurrent disease) and is sensitive to hormones. Researchers are testing two types of radiation therapy: Photon Therapy or Proton Therapy, delivered to the para-aortic (near the main artery in your abdomen) and pelvic lymph nodes. This is given along with standard hormone therapy (Androgen Deprivation Therapy) and Androgen Receptor Signaling Inhibitors. The goal is to see if this combination improves control of the cancer and preserves your quality of life. Success will be measured by how long you live without the cancer progressing (Progression-free Survival) for up to two years. The study plans to enroll 34 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 34 male participants aged 18 or older with oligorecurrent prostate cancer.
What's involved
Participants will receive radiation therapy daily, Monday through Friday, for five weeks (25 days), each session lasting up to 30 minutes. They will also receive standard Androgen Deprivation Therapy and Androgen Receptor Signaling Inhibitors.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years to measure progression-free survival.

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NCT06392295

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Miami
~34 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Para Aortic Radiation Therapy: Photon TherapyPara Aortic Radiation Therapy: Proton TherapyAndrogen Deprivation TherapyAndrogen Receptor Signaling Inhibitor

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free Survival (PFS)
Measured over Up to 2 years

Conditions

Prostate Cancer
Prostate Adenocarcinoma
Hormone Sensitive Prostate Cancer

Explore related trials

Prostate AdenocarcinomaProstate Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Benjamin J Rich, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Benjamin J Rich, MD
[email protected]
305-243-4200
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

a. No more than a total of 5 lesions on PSMA PET/CT scan (each lesion defined as positive with standardized uptake value (SUV) \> liver uptake and CT scan correlate)
b. No disease outside of the pelvic and sub-diaphragmatic para-aortic lymph nodes
c. At least one lesion in the sub-diaphragmatic pelvic or para-aortic lymph nodes
d. Non-bulky nodal disease (ie, tumor \<5 cm) 4. Prior pelvic radiation with disease response
a. Definitive radiation therapy to the prostate with or without treatment of the pelvic lymph nodes and/or
b. Salvage or adjuvant radiation therapy to the prostate bed following prostatectomy with or without treatment of the pelvic lymph nodes 5. Hormone-sensitive prostate cancer 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 7. Ability to understand the investigational nature, potential risks and benefits of the research study, and willingness to sign the written informed consent and HIPAA document(s) 8. Willingness to fill out quality of life and psychosocial forms 9. Willingness to participate in our institution's Prostate Cancer Database Protocol (ID# 20090767)

What this trial measures

  • Progression-free Survival (PFS)Up to 2 years

    Progression-free survival (PFS) among participants will be assessed during treatment and clinical follow-up. PFS is defined as the time from start of treatment until any of the following: Biochemical failure, escalation of therapy, radiological evidence of disease progression or death of any cause. Radiological evidence of disease progression will be assessed by the treating physician using the Response Evaluation Criteria in prostate-specific membrane antigen (PSMA) PET/CT (RECIP) version 1.0.