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

NCT ID: NCT06392295

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-03
• Study Completion Date: 2029-08-01

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Para Aortic Radiation Therapy: Photon Therapy

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

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

Androgen Receptor Signaling Inhibitor

Intervention Type: DRUG

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

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).

Intervention Type: RADIATION

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).

Intervention Type: RADIATION

Androgen Deprivation Therapy

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

Intervention Type: DRUG

Androgen Receptor Signaling Inhibitor

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

Intervention Type: DRUG

Other Intervention Names

PA-RT Photon Therapy; PA-RT Proton Therapy; ADT; ARSI

Eligibility Criteria

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 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Rich

Assistant Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin J Rich, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Benjamin J Rich, MD

Role: CONTACT

brich@miami.edu

305-243-4200

Alan Dal Pra, MD

Role: CONTACT

alan.dalpra@med.miami.edu

305-243-4200

Facility Contacts

Benjamin J Rich, MD

Role: primary

brich@miami.edu

305-243-4200

Other Identifiers

20231278

Identifier Type: -

Identifier Source: org_study_id