Radiation and Hormone Therapy for Prostate Cancer
(OCEAN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new methods to manage prostate cancer by combining radiation therapy with hormone therapy, also known as Androgen Deprivation Therapy (ADT). The goal is to better control the cancer and enhance patients' quality of life by targeting specific lymph nodes and using advanced imaging techniques. Men with prostate cancer who have no more than five cancer spots in specific areas below the diaphragm and have previously responded to pelvic radiation might be suitable candidates for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not have had androgen deprivation therapy or chemotherapy in the three months prior to the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that treatments like androgen deprivation therapy (ADT) are generally safe. Over 90% of patients experience a decrease in prostate-specific antigen levels, indicating a response to prostate cancer. Common side effects include hot flashes and tiredness.
For drugs that block androgen receptors, studies indicate similar safety, whether used alone or with ADT. Patients might experience side effects like tiredness and nausea, but these are usually manageable.
Para-aortic radiation therapy (PA-RT) is also well-tolerated, with low levels of side effects reported. Patients often maintain good disease control for up to two years after treatment. Overall, these treatments appear safe, though some side effects can occur.12345Why are researchers excited about this trial's treatments?
Most treatments for prostate cancer involve either surgery, radiation, or hormone therapy that aims to reduce androgen levels, which fuel cancer growth. However, this new approach is unique because it combines androgen deprivation therapy (ADT) and an androgen receptor signaling inhibitor (ARSI) with targeted para-aortic radiation therapy (PA-RT). This combination targets cancer cells more precisely while simultaneously cutting off their hormonal fuel, potentially improving effectiveness and reducing side effects. Researchers are excited about this treatment because it could offer a more comprehensive attack on cancer cells by integrating systemic hormone therapy with a focused radiation approach.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
Research has shown that treatments for prostate cancer, such as androgen deprivation therapy (ADT), can extend patient survival and lower prostate-specific antigen (PSA) levels. In this trial, participants will receive a combination of ADT and an androgen receptor signaling inhibitor (ARSI), including newer drugs like enzalutamide and abiraterone, which reduce PSA levels more effectively than ADT alone. Participants will also undergo para-aortic radiation therapy (PA-RT), which has yielded promising results, with 83.4% of patients experiencing no cancer progression for two years. Together, these treatments offer strong potential for controlling prostate cancer and improving patient outcomes.26789
Who Is on the Research Team?
Benjamin J Rich, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
Men with prostate cancer that has spread to a limited number of spots in the lymph nodes may join this trial. They should be fit for hormone therapy and radiation, and have had PSMA PET/CT scans showing disease progression.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Systemic Therapy
Participants undergo up to six months of systemic androgen deprivation therapy (ADT) and Androgen receptor signaling inhibitor (ARSI)
Radiation Therapy
Participants receive five weeks of para-aortic radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including progression-free survival and quality of life assessments
What Are the Treatments Tested in This Trial?
Interventions
- Androgen Deprivation Therapy
- Androgen Receptor Signaling Inhibitor
- Para Aortic Radiation Therapy
Androgen Deprivation Therapy is already approved in European Union, United States, Canada for the following indications:
- Prostate cancer
- Metastatic prostate cancer
- Recurrent prostate cancer
- Prostate cancer
- Metastatic prostate cancer
- Recurrent prostate cancer
- Localized prostate cancer
- Prostate cancer
- Metastatic prostate cancer
- Recurrent prostate cancer
- Localized prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor