Radiation therapy for recurrent prostate cancer

A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial

This study is testing a new way to use radiation therapy for men with recurrent prostate cancer to see if it helps control the cancer better while also keeping their quality of life intact.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University of Miami (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT06392295 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to improve the control of prostate cancer by delivering radiation therapy specifically to the para-aortic and pelvic lymph nodes, combined with systemic androgen suppression therapy. The study will also focus on preserving the quality of life for patients after radiation treatment. Additionally, it will utilize imaging results from PSMA PET/CT scans to evaluate and manage disease progression effectively.

Who should consider this trial

Good fit: Ideal candidates include males aged 18 and older with histologically proven prostate adenocarcinoma and oligorecurrent disease limited to specific lymph node regions.

Not a fit: Patients with extensive disease outside the pelvic and sub-diaphragmatic para-aortic lymph nodes may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes for patients with oligorecurrent prostate cancer.

How similar studies have performed: Other studies have shown promise in using targeted radiation therapy for prostate cancer, suggesting a potential for success in this approach.

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

Where this trial is running

Miami, Florida

• University of Miami — Miami, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Benjamin J Rich, MD — University of Miami
• Study coordinator: Benjamin J Rich, MD

Conditions: Prostate Cancer, Prostate Adenocarcinoma, Hormone Sensitive Prostate Cancer, Oligorecurrent Disease