PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial
University of Miami
34 participants
Jul 3, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria15
- 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)
Exclusion Criteria17
- 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
- Unwilling to fill out quality of life and psychosocial forms
- Participants with impaired decision-making capacity
Interventions
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).
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 will be administered as per standard of care.
Androgen receptor signaling inhibitor (ARSI) will be administered as per standard of care.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06392295