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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexMale
• Healthy volunteersNo

You may be able to join if

• Histologically proven prostate adenocarcinoma
• Male, ≥ 18 years old
• Oligorecurrent disease limited to the sub-diaphragmatic region with or without pelvic lymph nodes
• 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)
• 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
• Hormone-sensitive prostate cancer
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• 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)
• Willingness to fill out quality of life and psychosocial forms
• Willingness to participate in our institution's Prostate Cancer Database Protocol (ID# 20090767)

You cannot join if

• No pathological diagnosis of prostate adenocarcinoma
• Patient has more than 5 sites of metastatic disease
• Patient has history of bone and/or visceral metastasis
• No evidence of disease in the para-aortic or pelvic lymph nodes
• No staging with PSMA PET/CT scan
• History of prior radiation therapy outside the pelvis for prostate cancer
• Bulky nodal disease >5 cm in tumor size
• Androgen deprivation therapy (ADT) or chemotherapy in the three months prior to staging PSMA PET/CT scan (suggesting oligoprogressive disease, rather than true oligorecurrent disease) or at time of study enrollment
• Suspicious radiologic evidence of disease in the prostate on staging PSMA PET/CT scan without confirmatory negative prostate biopsy
• Implanted hardware which limits treatment planning or delivery (determined by treating physician)
• Castration-resistant prostate cancer (history of rising PSA with serum testosterone level <50 ng/dL)
• Patients with ECOG performance status > 2
• History of inflammatory bowel disease
• History of malignancy other than prostate cancer except for non-melanoma skin cancer
• Patients unable to consent or are prisoners
• Unwilling to fill out quality of life and psychosocial forms
• Participants with impaired decision-making capacity

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Para Aortic Radiation Therapy: Photon Therapy (Radiation): 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).
• Para Aortic Radiation Therapy: Proton Therapy (Radiation): 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).
• Androgen Deprivation Therapy (Drug): Androgen deprivation therapy will be administered as per standard of care.
• Androgen Receptor Signaling Inhibitor (Drug): Androgen receptor signaling inhibitor (ARSI) will be administered as per standard of care.

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• radiation: Part of the study plan

Main goals

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

Other goals

• Biochemical Failure-Free Survival (FFS)
• Metastasis-Free Survival
• Overall Survival (OS)
• Median Cause Specific Survival
• Proportion of Participants Undergoing Escalation of Therapy
• Proportion of Participants Experiencing Cumulative Late Grade ≥ 2 Treatment-Related Toxicity
• Change in Quality of Life Scores: EPIC 26 Short Form
• Change in Quality of Life Scores: HADS
• Change in Quality of Life Scores: IPSS
• Complete Early Response Rate

Planned enrollment: 34 (estimated).

• University of Miami, Miami, Florida

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06392295

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jun 15, 2026. Public record; not medical advice.