RECRUITING

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

Study Overview

Study Details

Study 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.

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami, Miami, Florida, United States, 33136

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Miami,

Benjamin J Rich, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

2029-08-01