A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial
Overview
- Phase
- Phase 2
- Intervention
- Androgen Deprivation Therapy
- Conditions
- Prostate Cancer
- Sponsor
- University of Miami
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Progression-free Survival (PFS)
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
The purpose of this prostate cancer research study is to learn about:
- Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen suppression therapy;
- Preserving quality of life after radiation therapy;
- Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans to evaluate and manage disease progression.
Investigators
Benjamin Rich
Assistant Professor of Clinical
University of Miami
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 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
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 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)
Arms & Interventions
PSMA-Guided PA-RT Group
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.
Intervention: Androgen Deprivation Therapy
PSMA-Guided PA-RT Group
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.
Intervention: Androgen Receptor Signaling Inhibitor
Outcomes
Primary Outcomes
Progression-free Survival (PFS)
Time Frame: Up to 2 years
Progression-free survival (PFS) among participants will be assessed during treatment and clinical follow-up. PFS is defined as the time from start of treatment until any of the following: Biochemical failure, escalation of therapy, radiological evidence of disease progression or death of any cause. Radiological evidence of disease progression will be assessed by the treating physician using the Response Evaluation Criteria in prostate-specific membrane antigen (PSMA) PET/CT (RECIP) version 1.0.
Secondary Outcomes
- Complete Early Response Rate(Up to 2 years)
- Median Cause Specific Survival(Up to 2 years)
- Proportion of Participants Undergoing Escalation of Therapy(Up to 2 years)
- Change in Quality of Life Scores: EPIC 26 Short Form(Up to 2 years)
- Biochemical Failure-Free Survival (FFS)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Proportion of Participants Experiencing Cumulative Late Grade ≥ 2 Treatment-Related Toxicity(Up to 2 years)
- Change in Quality of Life Scores: IPSS(Up to 2 years)
- Metastasis-Free Survival(Up to 2 years)
- Change in Quality of Life Scores: HADS(Up to 2 years)