34 Participants Needed

Radiation and Hormone Therapy for Prostate Cancer

(OCEAN Trial)

BJ
AD
Overseen ByAlan Dal Pra, MD
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: University of Miami
Must be taking: Androgen suppression
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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?

BJ

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

Willingness to fill out quality of life and psychosocial forms
My prostate cancer responds to hormonal therapy.
My lymph node tumor is smaller than 5 cm.
See 10 more

Exclusion Criteria

I am unable to make medical decisions for myself.
My cancer has a large tumor over 5 cm in size.
No staging with PSMA PET/CT scan
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Systemic Therapy

Participants undergo up to six months of systemic androgen deprivation therapy (ADT) and Androgen receptor signaling inhibitor (ARSI)

24 weeks

Radiation Therapy

Participants receive five weeks of para-aortic radiation therapy

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including progression-free survival and quality of life assessments

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Androgen Deprivation Therapy
  • Androgen Receptor Signaling Inhibitor
  • Para Aortic Radiation Therapy
Trial Overview The study is testing if targeting para-aortic lymph nodes with proton or photon radiation, alongside hormone suppression therapy and an androgen receptor signaling inhibitor, can better control prostate cancer while maintaining quality of life.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: PSMA-Guided PA-RT GroupExperimental Treatment4 Interventions

Androgen Deprivation Therapy is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as Androgen Deprivation Therapy for:
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Approved in United States as Androgen Deprivation Therapy for:
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Approved in Canada as Androgen Deprivation Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Published Research Related to This Trial

In a study of 37 men with intermediate- or high-risk localized prostate cancer, a combination of 6 months of androgen-deprivation therapy (ADT) with abiraterone acetate and radiation therapy resulted in a 55% rate of undetectable prostate-specific antigen (PSA) levels at 12 months, indicating effective disease control.
The treatment was associated with manageable toxicity, primarily grade 3 hypertension in 32% of patients, and 81% of participants experienced testosterone recovery within a median time of 9.2 months, suggesting a favorable impact on quality of life.
Combination of Radiation Therapy and Short-Term Androgen Blockade With Abiraterone Acetate Plus Prednisone for Men With High- and Intermediate-Risk Localized Prostate Cancer.Koontz, BF., Hoffman, KE., Halabi, S., et al.[2021]
In a study of 373 intermediate-risk prostate cancer patients treated with radiotherapy over 14 years, those aged 70 or younger who received radiotherapy alone had a higher risk of biochemical failure compared to those who received combined radiotherapy and androgen deprivation therapy (ADT).
The results suggest that short-term ADT may be beneficial for younger patients with favorable intermediate-risk prostate cancer, as it improved biochemical relapse-free survival from 82.1% to 94.0% compared to radiotherapy alone.
Radiotherapy with or without androgen deprivation therapy in intermediate risk prostate cancer?Amit, U., Lawrence, YR., Weiss, I., et al.[2020]
In a study of 94 prostate cancer patients, those who received combined androgen deprivation therapy (ADT) and radiation therapy showed significantly lower levels of prostate-specific antigen (T-PSA) and vascular endothelial growth factor (VEGF), indicating better disease control compared to those who only received radiation therapy.
The combined treatment group also experienced longer progression-free survival (mPFS) and overall survival (OS), highlighting the efficacy of combining ADT with radiotherapy in improving patient outcomes.
Efficacy and Prognostic Factors of Androgen Deprivation Therapy Combined with Radiation Therapy for Prostate Cancer.Zeng, S., Guan, G., Qin, Q., et al.[2022]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36710205/
Effects of Androgen Deprivation Therapy on Prostate Cancer ...We analysed the effectiveness of androgen deprivation therapy (ADT) for localised prostate cancer among patients, defined by the relative ...
Balancing Hormone Therapy: Mitigating Adverse Effects of ...Treatment advances including ADT have led to improvements in PCa management and survival, with trials reporting median survival of over 6 years ...
Clinical efficacy of different androgen deprivation therapies for ...This study evaluated the clinical efficacy of different androgen deprivation therapies in the treatment of PCa from the perspective of DCE-MRI
The Benefit of Short-Term Androgen Deprivation Therapy ...The present analysis confirms current knowledge that ST-ADT improves both OS and prostate-specific antigen-based outcomes for unselected patients with IR-PCa.
Cost-Effectiveness of Adding Androgen Deprivation Therapy ...Despite ADT-associated costs and long-term side effects, ADT was cost-effective in men with prostate cancer who received radiation therapy at $127,900 per ...
Androgen deprivation therapy for prostate cancer: long-term ...ADT can normalize serum prostate specific antigen in over 90% of patients and results in sizable tumor response in 80% to 90%. This treatment can be done either ...
a systematic review and network meta-analysis - PMCThis systematic review and network meta-analysis aimed to assess the comparative effectiveness and safety profiles of current combination ...
A 3-year Interim Analysis of the Observational J-ROCK StudyIn this study, we compared clinical and safety outcomes with different treatment regimens, using a large series of patients with high-risk metastatic hormone- ...
Short-term Androgen Deprivation Therapy and High-dose ...Among the 370 patients in the modified intention-to-treat population, 241 (65%) had intermediate-risk and 107 (28%) high-risk prostate cancer.
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