RECRUITING

PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer

Conditions

Prostate Cancer Prostate Adenocarcinoma Hormone Sensitive Prostate Cancer Oligorecurrent Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial

Quick Facts

Study Start:2024-07-03

Study Completion:2029-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06392295

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	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

Inclusion Criteria

Exclusion 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)

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

Contacts and Locations

Study Contact

Benjamin J Rich, MD

CONTACT

305-243-4200

brich@miami.edu

Alan Dal Pra, MD

CONTACT

305-243-4200

alan.dalpra@med.miami.edu

Principal Investigator

Benjamin J Rich, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Benjamin J Rich, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-03

Study Completion Date2029-08-01

Study Record Updates

Study Start Date2024-07-03

Study Completion Date2029-08-01

Terms related to this study

Keywords Provided by Researchers

Oligorecurrent Disease

Additional Relevant MeSH Terms

Prostate Cancer
Prostate Adenocarcinoma
Hormone Sensitive Prostate Cancer