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Hormone Therapy

Radiation and Hormone Therapy for Prostate Cancer (OCEAN Trial)

Phase 2

Recruiting

Led By Benjamin J Rich, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hormone-sensitive prostate cancer

Histologically proven prostate adenocarcinoma

Must not have

Implanted hardware which limits treatment planning or delivery (determined by treating physician)

Participants with impaired decision-making capacity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve control of prostate cancer by using radiation therapy on specific lymph nodes along with hormone therapy, while also focusing on maintaining the quality of life after treatment. Additionally, the study will use

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include fatigue, skin reactions from radiation, hormonal changes due to therapy (like hot flashes), gastrointestinal issues like diarrhea, and potential urinary problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer responds to hormonal therapy.

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My prostate cancer was confirmed through a tissue examination.

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I am a man and at least 18 years old.

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My cancer has not spread beyond the pelvic and para-aortic lymph nodes.

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I have at least one cancerous lesion below my diaphragm.

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I had pelvic radiation and my disease responded to it.

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My scan shows 5 or fewer spots that are more active than my liver.

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My lymph node tumor is smaller than 5 cm.

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My cancer has returned but is only in the area below my diaphragm, possibly including pelvic lymph nodes.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My doctor says my implanted device interferes with cancer treatment plans.

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I am unable to make medical decisions for myself.

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My cancer has a large tumor over 5 cm in size.

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I need assistance with my daily activities.

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My cancer has spread to more than 5 different areas.

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I have had radiation therapy for prostate cancer, but not in the pelvic area.

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My prostate cancer is not responding to hormone therapy.

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My scans show possible prostate cancer, but a biopsy hasn't confirmed it.

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My para-aortic lymph nodes do not show signs of cancer.

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I have a history of inflammatory bowel disease.

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My cancer has spread to my bones and/or internal organs.

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I have had cancer other than prostate or non-melanoma skin cancer.

Select...

I have not been diagnosed with prostate adenocarcinoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS)

Secondary study objectives

Biochemical Failure-Free Survival (FFS)

Change in Quality of Life Scores: EPIC 26 Short Form

Change in Quality of Life Scores: HADS

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PSMA-Guided PA-RT GroupExperimental Treatment4 Interventions

Participants in this group will undergo up to six months of systemic androgen deprivation therapy (ADT) and Androgen receptor signaling inhibitor (ARSI). During system therapy, participants will undergo five weeks of para-aortic radiation therapy. Total participation duration is up to five years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Androgen Deprivation Therapy

2008

Completed Phase 2

~110

0 / 23Eligibility criteria met