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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: CT scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans to evaluate and manage disease progression."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests radiation to lymph nodes in the pelvis and along the body's main artery, plus medicine that lowers male hormones. It is for men whose prostate cancer has returned in a few lymph nodes after earlier radiation. The study also looks at quality of life and uses special PSMA PET/CT scans to track the cancer.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Men age 18 or older with prostate adenocarcinoma, a type of cancer confirmed by a tissue test.
- Cancer has returned in 1 to 5 spots on a PSMA PET/CT scan, which helps find prostate cancer.
- Cancer is only in lymph nodes in the pelvis or along the main artery below the chest. Each tumor is smaller than 5 cm.
- Earlier radiation to the prostate or the area where it was removed helped control the cancer. Nearby pelvic lymph nodes may also have been treated.
- Cancer still responds to treatment that lowers male hormones.
- Able to care for yourself and be out of bed or a chair for at least half of your waking hours.
- Able to understand the study, its risks and benefits, and sign consent and health privacy forms.
- Willing to complete forms about quality of life and emotional and social well-being, and join the center's prostate cancer database study.
Who can't join
- No tissue-confirmed prostate adenocarcinoma, no PSMA PET/CT scan, or no cancer in the required lymph nodes; more than 5 cancer spots or a lymph node tumor larger than 5 cm.
- Cancer has ever spread to bones or internal organs, or you have had radiation for prostate cancer outside the pelvis.
- Hormone-lowering treatment or chemotherapy during the 3 months before the PSMA PET/CT scan, or at study entry.
- The scan suggests cancer in the prostate, unless a prostate tissue test shows no cancer.
- An implanted device or other hardware prevents safe planning or delivery of radiation.
- Cancer grows despite very low male hormone levels, or you need more help with daily care and activity than the study allows.
- A history of inflammatory bowel disease, which causes swelling in the gut, or any other cancer except non-melanoma skin cancer.
- Unable to make informed decisions or give consent, currently a prisoner, or unwilling to complete the required well-being forms.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 pelvic or 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) Exclusion Criteria: 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 or pelvic 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
Study sites (1)
FL
- University of Miami · Miami, FL 33136Benjamin J Rich, MD · Study contact · 305-243-4200 · brich@miami.eduBenjamin J Rich, MD · Principal investigatorAlan Dal Pra, MD · Principal investigatorMore trials in Miami