Prostate CancerPhase 2OCEANNCT06392295
PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
A Phase 2 study testing Para Aortic Radiation Therapy: Photon Therapy, Para Aortic Radiation Therapy: Proton Therapy and Androgen Deprivation Therapy in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Hormone Sensitive Prostate Cancer
- What is being tested?
- Para Aortic Radiation Therapy: Photon Therapy, Para Aortic Radiation Therapy: Proton Therapy and Androgen Deprivation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2024to 1 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven prostate adenocarcinoma
- Male, ≥ 18 years old
- 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
Show all 15Show fewer
- d. Non-bulky nodal disease (ie, tumor <5 cm)
- 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
- Hormone-sensitive prostate cancer
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- 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)
- Willingness to fill out quality of life and psychosocial forms
- Willingness to participate in our institution's Prostate Cancer Database Protocol (ID# 20090767)
Who cannot join
- No pathological diagnosis of prostate adenocarcinoma
- Patient has more than 5 sites of metastatic disease
- Patient has history of bone and/or visceral metastasis
- No evidence of disease in the para-aortic or pelvic lymph nodes
- No staging with PSMA PET/CT scan
- History of prior radiation therapy outside the pelvis for prostate cancer
Show all 17Show fewer
- Bulky nodal disease >5 cm in tumor size
- 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
- Suspicious radiologic evidence of disease in the prostate on staging PSMA PET/CT scan without confirmatory negative prostate biopsy
- Implanted hardware which limits treatment planning or delivery (determined by treating physician)
- Castration-resistant prostate cancer (history of rising PSA with serum testosterone level <50 ng/dL)
- Patients with ECOG performance status > 2
- History of inflammatory bowel disease
- History of malignancy other than prostate cancer except for non-melanoma skin cancer
- Patients unable to consent or are prisoners
- Unwilling to fill out quality of life and psychosocial forms
- Participants with impaired decision-making capacity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Benjamin J Rich, MD, 305-243-4200, brich@miami.edu
Benjamin J Rich, MD
About this study
Official title: A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial
The purpose of this prostate cancer research study is to learn about:
- Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen suppression therapy;
- Preserving quality of life after radiation therapy;
- Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans to evaluate and manage disease progression.
- Being tested
- Para Aortic Radiation Therapy: Photon Therapy, Para Aortic Radiation Therapy: Proton Therapy, Androgen Deprivation Therapy, Androgen Receptor Signaling Inhibitor
- Keywords
- Oligorecurrent Disease
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Para Aortic Radiation Therapy: Photon TherapyRadiation
Also called PA-RT Photon Therapy
Participants will undergo five weeks of PA-RT daily, for up to 30 minutes per day for 25 days, Monday through Friday, consisting of a total dose of 50 grays (Gys) delivered in 25 fractions to the Clinical Tumor Volume (CTV).
Para Aortic Radiation Therapy: Proton TherapyRadiation
Also called PA-RT Proton Therapy
Participants will undergo five weeks of PA-RT daily, for up to 30 minutes per day for 25 days, Monday through Friday, consisting of a total dose of 60 to 65 Gys delivered in 25 fractions to the Gross Tumor Volume (GTVn).
Androgen Deprivation TherapyDrug
Also called ADT
Androgen deprivation therapy will be administered as per standard of care.
Androgen Receptor Signaling InhibitorDrug
Also called ARSI
Androgen receptor signaling inhibitor (ARSI) will be administered as per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| PSMA-Guided PA-RT Group | Experimental | 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. Receives: Radiation: Para Aortic Radiation Therapy: Photon Therapy; Radiation: Para Aortic Radiation Therapy: Proton Therapy; Drug: Androgen Deprivation Therapy; Drug: Androgen Receptor Signaling Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Progression-free survival (PFS) among participants will be assessed during treatment and clinical follow-up. PFS is defined as the time from start of treatment until any of the following: Biochemical failure, escalation of therapy, radiological evidence of disease progression or death of any cause. Radiological evidence of disease progression will be assessed by the treating physician using the Response Evaluation Criteria in prostate-specific membrane antigen (PSMA) PET/CT (RECIP) version 1.0.
Measured: Up to 2 years
Secondary outcomes (10)
Biochemical Failure-Free Survival (FFS)
Biochemical failure-free survival among participants will be assessed during treatment and clinical follow-up. Biochemical failure-free survival is defined as the time from study enrollment to time of biochemical failure. Biochemical failure, as adapted from the Prostate Cancer Working Group 2 (PCWG2), is defined as when prostate-specific antigen (PSA) level increases ≥ 25% and ≥ 2 ng/mL above the nadir, which is confirmed by a second value obtained three or more weeks later.
Measured: Up to 2 years
Metastasis-Free Survival
Metastasis-free survival among participants will be assessed during treatment and clinical follow-up. Metastasis-free survival is defined as the time from study enrollment to clinical or radiological evidence of metastatic disease or death.
Measured: Up to 2 years
Overall Survival (OS)
Overall survival (OS) among participants will be assessed. OS is defined as the time from study enrollment to death of any cause.
Measured: Up to 2 years
Median Cause Specific Survival
Median case specific survival among participants will be assessed. Median cause specific survival is defined as the time from study enrollment to death secondary to prostate cancer.
Measured: Up to 2 years
Proportion of Participants Undergoing Escalation of Therapy
The proportion of participants undergoing escalation of therapy will be reported. Escalation of therapy is defined as subsequent course of radiation therapy or change in systemic therapy (except for intolerable side effects).
Measured: Up to 2 years
Proportion of Participants Experiencing Cumulative Late Grade ≥ 2 Treatment-Related Toxicity
The proportion of participants experience late grade ≥ 2 treatment related toxicity between 90 days and two years following para-aortic radiation therapy (PA-RT) will be reported. Late toxicity is defined as Grade ≥ 2 treatment-related toxicities occurring more than 90 days after completing para-aortic radiation therapy (PA-RT). The severity of the reactions to the treatment will be assessed according to using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 2 years
Change in Quality of Life Scores: EPIC 26 Short Form
Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite 26 Short Form (EPIC-26) to evaluate patient function and satisfaction after prostate cancer treatment. EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Measured: Up to 2 years
Change in Quality of Life Scores: HADS
Health-related Quality of Life (HRQOL) will be measured using the Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a validated instrument used to measure patient symptoms of anxiety and depression. The HADS questionnaire consists of six questions, three questions each in two domains, HADS-Anxiety and HADS-Depression. Scores in each domain range from 0-9, with higher scores representing greater levels of anxiety and depression.
Measured: Up to 2 years
Change in Quality of Life Scores: IPSS
Health-related quality of life (HRQOL) will be measured using the International Prostate Symptom Score (IPSS) to evaluate patient urinary function and quality of life. There are 7 questions related to urinary function. Responses are on a scale from 0 ("not at all") to 5 ("almost always"), with higher scores indicating higher levels of urinary dysfunction. There is one quality of life question related to urinary symptoms. Responses are on a scale from 0 ("delighted") to 6 ("terrible"). Responses will be tabulated for a composite score.
Measured: Up to 2 years
Complete Early Response Rate
The Complete Early Response rate among participants will be reported. Complete Early Response is defined as seen as on the 3-month post-PA-RT PSMA PET/CT scan using the Response Evaluation Criteria in prostate-specific membrane antigen (PSMA) PET/CT (RECIP) version 1.0; or a PSA level ≤ 0.1 ng/mL. A composite of these two evaluations will be used to determine the complete early response rate.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start3 Jul 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Rich, University of Miami
- Investigators
- Benjamin J Rich, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392295
- Sponsor's protocol ID
- 20231278
- Acronym
- OCEAN
- Status last verified
- Jun 2026
- First submitted
- 25 Apr 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial
- ClinicalTrials.gov ID
- NCT06392295
- Acronym / sponsor ID
- OCEAN / 20231278
- Keywords
- Oligorecurrent Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this prostate cancer research study is to learn about:
- Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen suppression therapy;
- Preserving quality of life after radiation therapy;
- Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans to evaluate and manage disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSMA-Guided PA-RT Group | Experimental | Radiation: Para Aortic Radiation Therapy: Photon Therapy, Radiation: Para Aortic Radiation Therapy: Proton Therapy, Drug: Androgen Deprivation Therapy, Drug: Androgen Receptor Signaling InhibitorParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically proven prostate adenocarcinoma
- Male, ≥ 18 years old
- Oligorecurrent disease limited to the sub-diaphragmatic region with or without pelvic lymph nodes
- Prior pelvic radiation with disease response
- Hormone-sensitive prostate cancer
Key exclusion criteria (17 listed)
- No pathological diagnosis of prostate adenocarcinoma
- Patient has more than 5 sites of metastatic disease
- Patient has history of bone and/or visceral metastasis
- No evidence of disease in the para-aortic or pelvic lymph nodes
- No staging with PSMA PET/CT scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Para Aortic Radiation Therapy: Photon TherapyAlso: PA-RT Photon TherapyParticipants will undergo five weeks of PA-RT daily, for up to 30 minutes per day for 25 days, Monday through Friday, consisting of a total dose of 50 grays (Gys) delivered in 25 fractions to the Clinical Tumor Volume (CTV). | Radiation | PSMA-Guided PA-RT Group |
| Para Aortic Radiation Therapy: Proton TherapyAlso: PA-RT Proton TherapyParticipants will undergo five weeks of PA-RT daily, for up to 30 minutes per day for 25 days, Monday through Friday, consisting of a total dose of 60 to 65 Gys delivered in 25 fractions to the Gross Tumor Volume (GTVn). | Radiation | PSMA-Guided PA-RT Group |
| Androgen Deprivation TherapyAlso: ADTAndrogen deprivation therapy will be administered as per standard of care. | Drug | PSMA-Guided PA-RT Group |
| Androgen Receptor Signaling InhibitorAlso: ARSIAndrogen receptor signaling inhibitor (ARSI) will be administered as per standard of care. | Drug | PSMA-Guided PA-RT Group |
Primary outcome
Progression-free Survival (PFS)
Time frame: Up to 2 years
Progression-free survival (PFS) among participants will be assessed during treatment and clinical follow-up. PFS is defined as the time from start of treatment until any of the following: Biochemical failure, escalation of therapy, radiological evidence of disease progression or death of any cause. Radiological evidence of disease progression will be assessed by the treating physician using the Response Evaluation Criteria in prostate-specific membrane antigen (PSMA) PET/CT (RECIP) version 1.0.
10 secondary outcomes
Biochemical Failure-Free Survival (FFS)
Time frame: Up to 2 years
Metastasis-Free Survival
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Median Cause Specific Survival
Time frame: Up to 2 years
Proportion of Participants Undergoing Escalation of Therapy
Time frame: Up to 2 years
Proportion of Participants Experiencing Cumulative Late Grade ≥ 2 Treatment-Related Toxicity
Time frame: Up to 2 years
Change in Quality of Life Scores: EPIC 26 Short Form
Time frame: Up to 2 years
Change in Quality of Life Scores: HADS
Time frame: Up to 2 years
Change in Quality of Life Scores: IPSS
Time frame: Up to 2 years
Complete Early Response Rate
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin J Rich, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Para Aortic Radiation Therapy: Photon Therapy, Para Aortic Radiation Therapy: Proton Therapy and Androgen Deprivation Therapy in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin J Rich, MD (305-243-4200, brich@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.