PSMA PET/CT Guided Para-aortic Radiation Therapy for the Treatment of Oligorecurrent Prostate Cancer, the OCEAN Trial

Status: active

This phase II trial tests how well prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) guided para-aortic radiation therapy (PA-RT) with short term androgen suppression therapy works in treating patients with prostate cancer that has come back to several sites after a period of improvement (oligorecurrent). PSMA PET is a type of scan used to detect prostate cancer tumors. PSMA is a radioactive tracer that binds to a specific protein that is found on prostate tumor cells. The PSMA tracer shows the areas on the PET scan where tumor cells are active. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer. Because some cancers take up the PSMA it can be seen with PET. CT uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient’s body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Androgen deprivation therapy (ADT) lowers the amount of testosterone made by the body and androgen receptor signaling inhibitors (ARSI) works by blocking androgen receptors on tumor cells. This may help stop the growth of tumor cells that need testosterone to grow. Using PSMA PET/CT guided PA-RT with androgen suppression therapy may be an effective treatment for patients with oligorecurrent prostate cancer.

Inclusion Criteria

Histologically proven prostate adenocarcinoma
Male, ≥ 18 years old
Oligorecurrent disease limited to the sub-diaphragmatic region with or without pelvic lymph nodes * 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) * No disease outside of the pelvic and sub-diaphragmatic para-aortic lymph nodes * At least one lesion in the sub-diaphragmatic para-aortic lymph nodes * Non-bulky nodal disease (i.e., tumor < 5 cm)
Prior pelvic radiation with disease response * Definitive radiation therapy to the prostate with or without treatment of the pelvic lymph nodes and/or * 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 Health Insurance Portability and Accountability Act (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 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

Additional locations may be listed on ClinicalTrials.gov for NCT06392295.

United States

Email: bjr38@miami.edu

UM Sylvester Comprehensive Cancer Center at Kendall

Status: Active

Contact: Benjamin James Rich

Phone: 305-689-0608

Email: bjr38@miami.edu

Plantation

UM Sylvester Comprehensive Cancer Center at Plantation

Status: Active

Contact: Benjamin James Rich

Phone: 305-689-0608

Email: bjr38@miami.edu

PRIMARY OBJECTIVE:

I. To determine the efficacy of para-aortic radiation therapy (PA-RT) plus 6- or 12-month intensified androgen suppression in reducing disease progression at two years in patients with oligorecurrent prostate cancer that is limited to the subdiaphragmatic para-aortic lymph nodes.

SECONDARY OBJECTIVES:

I. To determine the rate of biochemical failure, metastasis-free survival, overall survival, cause-specific mortality, and systemic or radiation treatment escalation following PA-RT.

II. To determine rate of undetectable prostate specific antigen (PSA) under supracastrate testosterone levels.

III. To determine the toxicity of PA-RT plus 6- or 12-month intensified androgen suppression for patients with oligorecurrent prostate cancer that is limited to the subdiaphragmatic para-aortic lymph nodes.

IV. To determine health-related quality of life following treatment with PA-RT.

V. To determine the rate of complete early response on PSMA PET/CT scan after PA-RT.

EXPLORATORY OBJECTIVES:

I. To determine the rate of testosterone recovery following 6-month intensified androgen suppression.

II. To determine in a nonrandomized manner differences in toxicity between patients treated with photon versus proton beam radiation therapy.

III. To explore the feasibility of radiomics platform for prognosticating PA-RT.

IV. To analyze the quantity, viability, and gene expression of circulating tumor cells (CTCs), cell free deoxyribonucleic acid (DNA) (cfDNA), exosome ribonucleic acid (RNA), and cancer-associated fibroblasts (CAFs).

V. To explore cyclic guanosine monophosphate (cGMP) levels in the serum as an early predictive biomarker of castration-resistant prostate cancer (CRPC).

VI. To draw and store serum, plasma, and buffy coat for research analysis.

VII. To explore the predictive and prognostic utility of PSMA PET/CT scans.

VIII. To determine hematological toxicity in response to PA-RT through serial complete blood counts (CBCs) with differential.

IX. To explore baseline biomarkers compared to other university prospective trials (BLASTm, MAST).

X. To explore next-generation sequencing data from tumor samples and blood.

OUTLINE:

Patients undergo PA-RT over 30 minutes once daily (QD) on Monday-Friday for 5 weeks, and receive standard of care ADT and ARSI for 6 months. Patients with residual disease after 6 months may receive ADT and ARSI for an additional 6 months (12 months total). Patients also undergo PSMA PET/CT at baseline and 3 months after PA-RT. Additionally, patients undergo blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 3 and 9 months, and yearly for up to 5 years.

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PSMA PET/CT Guided Para-aortic Radiation Therapy for the Treatment of Oligorecurrent Prostate Cancer, the OCEAN Trial

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