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Hormone Therapy

PSMA-Guided PA-RT Group for Prostate Cancer (OCEAN Trial)

Phase 2

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

OCEAN Trial 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.Check my eligibility

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.See study design

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.

OCEAN Trial 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.

Select...

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

OCEAN Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS)

Secondary outcome measures

Biochemical Failure-Free Survival (FFS)

Change in Quality of Life Scores: EPIC 26 Short Form

Change in Quality of Life Scores: HADS

+7 more

OCEAN 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 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

909 Previous Clinical Trials

411,337 Total Patients Enrolled

17 Trials studying Prostate Cancer

3,887 Patients Enrolled for Prostate Cancer

Benjamin J Rich, MDPrincipal InvestigatorUniversity of Miami

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase of this medical study currently ongoing?

"Information from clinicaltrials.gov indicates that this particular investigation is not presently seeking individuals for enrollment. Although initially listed on August 1st, 2024 and last revised on April 25th, 2024, it currently has no active recruitment ongoing. Nonetheless, there are a total of 1413 other trials actively pursuing suitable candidates for participation at the moment."

Answered by AI

Does the FDA endorse the use of PSMA-guided prostate-specific membrane antigen radioligand therapy (PSMA-PA RT)?

"The safety evaluation for PSMA-Guided PA-RT Group is rated as 2 by our team at Power, considering this trial falls under Phase 2. While there is existing data supporting safety, evidence backing efficacy remains lacking."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Benjamin Rich 2024. "PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06392295.

All > Recurrent Prostate Cancer