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

Last updated: June 13, 2025
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

2

Condition

Adenocarcinoma

Prostate Cancer, Early, Recurrent

Urologic Cancer

Treatment

Para Aortic Radiation Therapy: Proton Therapy

Para Aortic Radiation Therapy: Photon Therapy

Androgen Receptor Signaling Inhibitor

Clinical Study ID

NCT06392295
20231278
  • Ages > 18
  • Male

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically proven prostate adenocarcinoma

  2. Male, ≥ 18 years old

  3. Oligorecurrent disease limited to the sub-diaphragmatic region with or withoutpelvic lymph nodes

  • a. No more than a total of 5 lesions on PSMA PET/CT scan (each lesion definedas positive with standardized uptake value (SUV) > liver uptake and CT scancorrelate)

  • b. No disease outside of the pelvic and sub-diaphragmatic para-aortic lymphnodes

  • c. At least one lesion in the sub-diaphragmatic para-aortic lymph nodes

  • d. Non-bulky nodal disease (ie, tumor <5 cm)

  1. Prior pelvic radiation with disease response
  • a. Definitive radiation therapy to the prostate with or without treatment ofthe pelvic lymph nodes and/or

  • b. Salvage or adjuvant radiation therapy to the prostate bed followingprostatectomy with or without treatment of the pelvic lymph nodes

  1. Hormone-sensitive prostate cancer

  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

  3. Ability to understand the investigational nature, potential risks and benefits ofthe research study, and willingness to sign the written informed consent and HIPAAdocument(s)

  4. Willingness to fill out quality of life and psychosocial forms

  5. Willingness to participate in our institution's Prostate Cancer Database Protocol (ID# 20090767)

Exclusion

Exclusion Criteria:

  1. No pathological diagnosis of prostate adenocarcinoma

  2. Patient has more than 5 sites of metastatic disease

  3. Patient has history of bone and/or visceral metastasis

  4. No evidence of disease in the para-aortic lymph nodes

  5. No staging with PSMA PET/CT scan

  6. History of prior radiation therapy outside the pelvis for prostate cancer

  7. Bulky nodal disease >5 cm in tumor size

  8. Androgen deprivation therapy (ADT) or chemotherapy in the three months prior tostaging PSMA PET/CT scan (suggesting oligoprogressive disease, rather than trueoligorecurrent disease) or at time of study enrollment

  9. Suspicious radiologic evidence of disease in the prostate on staging PSMA PET/CTscan without confirmatory negative prostate biopsy

  10. Implanted hardware which limits treatment planning or delivery (determined bytreating physician)

  11. Castration-resistant prostate cancer (history of rising PSA with serum testosteronelevel <50 ng/dL)

  12. Patients with ECOG performance status > 2

  13. History of inflammatory bowel disease

  14. History of malignancy other than prostate cancer except for non-melanoma skin cancer

  15. Patients unable to consent or are prisoners

  16. Unwilling to fill out quality of life and psychosocial forms

  17. Participants with impaired decision-making capacity

Study Design

Total Participants: 34
Treatment Group(s): 4
Primary Treatment: Para Aortic Radiation Therapy: Proton Therapy
Phase: 2
Study Start date:
July 03, 2024
Estimated Completion Date:
August 01, 2029

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

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