Clinical trial NCT06392295: PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
Official title: A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Hormone Sensitive Prostate Cancer
Keywords: Oligorecurrent Disease
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Biochemical Failure-Free Survival (FFS)
timeFrame: Up to 2 years
measure: Metastasis-Free Survival
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
measure: Median Cause Specific Survival
timeFrame: Up to 2 years
measure: Proportion of Participants Undergoing Escalation of Therapy
timeFrame: Up to 2 years
measure: Proportion of Participants Experiencing Cumulative Late Grade ≥ 2 Treatment-Related Toxicity
timeFrame: Up to 2 years
measure: Change in Quality of Life Scores: EPIC 26 Short Form
timeFrame: Up to 2 years
measure: Change in Quality of Life Scores: HADS
timeFrame: Up to 2 years
measure: Change in Quality of Life Scores: IPSS
timeFrame: Up to 2 years
measure: Complete Early Response Rate
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Benjamin J Rich, MD
role: PRINCIPAL_INVESTIGATOR
References: