PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer (OCEAN)

University of Miami

Status and phase: Enrolling; Phase 2

Conditions: Prostate Adenocarcinoma; Hormone Sensitive Prostate Cancer; Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06392295

20231278

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

PSMA-Guided PA-RT Group

Experimental group

Description:

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.

Treatment:

Radiation: Para Aortic Radiation Therapy: Proton Therapy

Radiation: Para Aortic Radiation Therapy: Photon Therapy

Drug: Androgen Receptor Signaling Inhibitor

Drug: Androgen Deprivation Therapy