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

NCT06392295 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: 20231278
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prostate cancer research study is to learn about:

1. 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. 2.Preserving quality of life after radiation therapy;
3. 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

Keywords

Oligorecurrent Disease

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  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.

  Up to 2 years

Secondary Outcomes (10)

• Biochemical Failure-Free Survival (FFS)

  Up to 2 years

• Metastasis-Free Survival

  Up to 2 years

• Overall Survival (OS)

  Up to 2 years

• Median Cause Specific Survival

  Up to 2 years

• Proportion of Participants Undergoing Escalation of Therapy

  Up to 2 years

Study Arms (1)

PSMA-Guided PA-RT Group

EXPERIMENTAL

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.

Radiation: Para Aortic Radiation Therapy: Photon Therapy; Radiation: Para Aortic Radiation Therapy: Proton Therapy; Drug: Androgen Deprivation Therapy; Drug: Androgen Receptor Signaling Inhibitor

Interventions

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).

Also known as: PA-RT Photon Therapy

PSMA-Guided PA-RT Group

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).

Also known as: PA-RT Proton Therapy

PSMA-Guided PA-RT Group

Androgen Deprivation Therapy DRUG

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

Also known as: ADT

PSMA-Guided PA-RT Group

Androgen Receptor Signaling Inhibitor DRUG

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

Also known as: ARSI

PSMA-Guided PA-RT Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 may not qualify 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 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Benjamin J Rich, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin J Rich, MD

CONTACT

305-243-4200; brich@miami.edu

Alan Dal Pra, MD

CONTACT

305-243-4200; alan.dalpra@med.miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: July 3, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2029
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)