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

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

About This Trial

  • This study is testing whether using targeted radiation therapy alongside hormone therapy can help control cancer that has returned, while also protecting your quality of life.
  • Doctors will use specialized imaging scans to precisely find and deliver radiation to lymph nodes in the lower belly and pelvis.
  • The trial is for men whose prostate cancer has come back in only a few lymph nodes (up to five spots) after prior radiation, with no spread to the bones or other organs.
  • Before considering this study, you should know that you cannot have received recent chemotherapy or hormone therapy, and you will be asked to complete regular questionnaires about your daily well-being.

More Information

  • 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.

Who Can Enroll

  • Age Range: 18 years and older
  • Gender: Male
  • Who This Trial is For: This study is testing whether using targeted radiation therapy alongside hormone therapy can help control cancer that has returned, while also protecting your quality of life.

Study Details

  • Start Date: July 3, 2024
  • Lead Sponsor: University of Miami
Full 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 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 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

Treatments

  • Radiation: Para Aortic Radiation Therapy: Photon Therapy
  • Radiation: Para Aortic Radiation Therapy: Proton Therapy
  • Drug: Androgen Deprivation Therapy
  • Drug: Androgen Receptor Signaling Inhibitor
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