Recruiting NCT06392295
PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Para Aortic Radiation Therapy: Photon Therapy, Para Aortic Radiation Therapy: Proton Therapy, Androgen Deprivation Therapy, Androgen Receptor Signaling Inhibitor.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Prostate Adenocarcinoma, Hormone Sensitive Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial
Overview
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.
Interventions
- Radiation 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). - 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). - Drug Androgen Deprivation Therapy
Androgen deprivation therapy will be administered as per standard of care. - Drug Androgen Receptor Signaling Inhibitor
Androgen receptor signaling inhibitor (ARSI) will be administered as per standard of care.
Primary outcome measures
- Progression-free Survival (PFS) [Time frame: Up to 2 years]
Secondary outcome measures (10)
- Biochemical Failure-Free Survival (FFS) [Time frame: Up to 2 years]
- Metastasis-Free Survival [Time frame: Up to 2 years]
- Overall Survival (OS) [Time frame: Up to 2 years]
- Median Cause Specific Survival [Time frame: Up to 2 years]
- Proportion of Participants Undergoing Escalation of Therapy [Time frame: Up to 2 years]
- Proportion of Participants Experiencing Cumulative Late Grade ≥ 2 Treatment-Related Toxicity [Time frame: Up to 2 years]
- Change in Quality of Life Scores: EPIC 26 Short Form [Time frame: Up to 2 years]
- Change in Quality of Life Scores: HADS [Time frame: Up to 2 years]
- Change in Quality of Life Scores: IPSS [Time frame: Up to 2 years]
- Complete Early Response Rate [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- 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 pelvic or 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 criteria
- 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 or pelvic 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT06392295 · 20231278