Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06392295

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

Led by University of Miami · Updated on 2025-06-15

34

Participants Needed

1

Research Sites

265 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically proven prostate adenocarcinoma
  • Male, 18 years old
  • Oligorecurrent disease limited to the sub-diaphragmatic region with or without pelvic lymph nodes
  • No more than 5 lesions on PSMA PET/CT scan
  • No disease outside pelvic and sub-diaphragmatic para-aortic lymph nodes
  • At least one lesion in the sub-diaphragmatic para-aortic lymph nodes
  • Non-bulky nodal disease (tumor <5 cm)
  • Prior pelvic radiation with disease response
  • Hormone-sensitive prostate cancer
  • ECOG Performance Status of 0-2
  • Ability to understand and consent to the study
  • Willingness to complete quality of life and psychosocial forms
  • Willing to participate in the institution's Prostate Cancer Database Protocol
Not Eligible

You will not qualify if you...

  • No pathological diagnosis of prostate adenocarcinoma
  • More than 5 metastatic disease sites
  • History of bone and/or visceral metastasis
  • No evidence of disease in para-aortic lymph nodes
  • No staging with PSMA PET/CT scan
  • Prior radiation therapy outside the pelvis for prostate cancer
  • Bulky nodal disease (>5 cm tumor size)
  • Androgen deprivation therapy or chemotherapy within 3 months before PSMA PET/CT staging or at enrollment
  • Suspicious prostate disease on PSMA PET/CT without negative biopsy confirmation
  • Implanted hardware limiting treatment planning or delivery
  • Castration-resistant prostate cancer
  • ECOG performance status greater than 2
  • History of inflammatory bowel disease
  • History of malignancy other than prostate cancer except non-melanoma skin cancer
  • Unable to consent or prisoner status
  • Unwilling to complete quality of life and psychosocial forms
  • Impaired decision-making capacity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

B

Benjamin J Rich, MD

CONTACT

A

Alan Dal Pra, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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