Recruiting
Phase 2

PSMA-Directed Radiation Therapy

Sponsor:

University of Miami

Code:

NCT06392295

Conditions

Prostate Cancer

Prostate Adenocarcinoma

Hormone Sensitive Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Para Aortic Radiation Therapy: Photon Therapy

Para Aortic Radiation Therapy: Proton Therapy

Androgen Deprivation Therapy

Androgen Receptor Signaling Inhibitor

Study Details

Brief 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

Study ID

NCT06392295

Start date

Jul 3, 2024

Status verified date

Jun, 2026

Completion date

Aug 1, 2029

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Histologically proven prostate adenocarcinoma
2. Male, ≥ 18 years old
3. 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)
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)

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 or pelvic 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 to staging PSMA PET/CT scan (suggesting oligoprogressive disease, rather than true oligorecurrent disease) or at time of study enrollment
9. Suspicious radiologic evidence of disease in the prostate on staging PSMA PET/CT scan without confirmatory negative prostate biopsy
10. Implanted hardware which limits treatment planning or delivery (determined by treating physician)
11. Castration-resistant prostate cancer (history of rising PSA with serum testosterone level <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

Enrollment

34 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PSMA-Guided PA-RT Group

Participants in this group will undergo up to six months of systemic androgen deprivation therapy (ADT) and Androgen receptor signaling inhibitor (ARSI). During system therapy, participants will undergo five weeks of para-aortic radiation therapy.

Total participation duration is up to five years.

Interventions

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).

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).

Androgen Deprivation Therapy

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

Androgen Receptor Signaling Inhibitor

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

Primary outcome measure

  • Progression-free Survival (PFS) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Benjamin J Rich, MD

305-243-4200brich@miami.edu

Principal Investigator:

Benjamin J Rich, MD

More Information

Sponsor

University of Miami

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • Oligorecurrent Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-06-16.