Prostate CancerPhase 2/3NCT05381103
PSMA-PET to Guide Prostatectomy
A Phase 2/3 study testing PSMA-PET and SOC MRI and SOC MRI in people with Prostate Cancer, run by Five Eleven Pharma, Inc. at 1 site in United States.
Trial summary
In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSMA-PET and SOC MRI and SOC MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 1 Dec 2028
- Phase
- Phase 2/3
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Significant prostate cancer:
- Gleason 3+4 ≥1 core with pattern 4 ≥20%
- Gleason 3+4 ≥1 core with ≥50% total involvement of core OR ≥3 cores of Gleason 3+4 OR
- NCCN unfavorable intermediate risk OR
- Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5 AND
- Baseline sexual function (IIEF-EF > 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND
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- The patient desires to maintain erections following treatment
- Planned to undergo a standard of care MRI or recently completed standard of care MRI within 6 months of scheduled date of surgery. Note: For subjects whose SOC MRI is not within 6 months or not 3Tesla, they may be enrolled in the study and the MRI will be repeated as a research study. The research MRI will not be billed to the subject's insurance, but will be scheduled at IU ORI, at no cost to study participant.
- Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent.
Who cannot join
- Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
- Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed, since MRI is required for comparison).
- Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
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
Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
Indianapolis, Indiana, 46202
Mark Green, Ph.D
About this study
Official title: PSMA-PET to Guide Prostatectomy: A Randomized Trial
In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.
- Conditions
- Prostate Cancer
- Being tested
- PSMA-PET and SOC MRI, SOC MRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA-PET and SOC MRIDiagnostic test
60 min continuous acquisition of PET data after 3-6 mCI injection of [68Ga]P16-093 followed by contrast-CT
SOC MRIDiagnostic test
Standard of care MRI
| Study group | Role | What they receive |
|---|---|---|
| PSMA-PET and SOC MRI prior to surgery | Experimental | Not described Receives: Diagnostic Test: PSMA-PET and SOC MRI |
| SOC MRI prior to surgery | Active comparator | Not described Receives: Diagnostic Test: SOC MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Measured: 1 month
IIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Measured: 3 months
IIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Measured: 6 months
IIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Measured: 12 months
IIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Measured: 18 months
Secondary outcomes (9)
Change in treatment plan
Proportion of patients whose treatment plan would be changed by PSMA-PET. Treatment changes are defined as any change in surgical resection plan that affects one of 4 critical regions for quality of life
Measured: 1 month
Ratio of positive surgical margins to nerve bundles spared
Measured: 1 month
EPE detection
Sensitivity/Specificity for extra-prostatic extension of cancer at the nerve bundles
Measured: 1 month
Incontinence bother
Expanded Prostate Cancer Index Composite (EPIC-26) questions 1-2
Measured: 18 months
Incontinence: using 0-1 pads per day
Expanded Prostate Cancer Index Composite (EPIC-26) question 3
Measured: 18 months
Urgency/frequency
Expanded Prostate Cancer Index Composite (EPIC-26) questions 4-5
Measured: 18 months
Erectile dysfunction: ability to achieve erection sufficient for penetration
IIEF question 3
Measured: 18 months
Overall mental and physical health
Short Form quality of life questionnaire (SF-36)
Measured: 18 months
Surgical margins
postive surgical margin rates
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Oct 2021
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Dec 2028 (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.
- 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Five Eleven Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Clinton Bahler, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381103
- Sponsor's protocol ID
- IU_CLN02_EPE
- Status last verified
- Oct 2024
- First submitted
- 29 Apr 2022
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSMA-PET to Guide Prostatectomy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05381103
- Acronym / sponsor ID
- IU_CLN02_EPE
- Conditions
- Prostate Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Five Eleven Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 19 May 2022 (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.
In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSMA-PET and SOC MRI prior to surgery | Experimental | Diagnostic Test: PSMA-PET and SOC MRI |
| SOC MRI prior to surgery | Active comparator | Diagnostic Test: SOC MRI |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Significant prostate cancer:
- Gleason 3+4 ≥1 core with pattern 4 ≥20%
- Gleason 3+4 ≥1 core with ≥50% total involvement of core OR ≥3 cores of Gleason 3+4 OR
- NCCN unfavorable intermediate risk OR
- Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5 AND
Key exclusion criteria (3 listed)
- Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
- Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed, since MRI is required for comparison).
- Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
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 |
|---|---|---|
| PSMA-PET and SOC MRI60 min continuous acquisition of PET data after 3-6 mCI injection of [68Ga]P16-093 followed by contrast-CT | Diagnostic test | PSMA-PET and SOC MRI prior to surgery |
| SOC MRIStandard of care MRI | Diagnostic test | SOC MRI prior to surgery |
Primary outcome
IIEF-EF sub scale score
Time frame: 1 month
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
IIEF-EF sub scale score
Time frame: 3 months
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
IIEF-EF sub scale score
Time frame: 6 months
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
IIEF-EF sub scale score
Time frame: 12 months
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
IIEF-EF sub scale score
Time frame: 18 months
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
9 secondary outcomes
Change in treatment plan
Time frame: 1 month
Ratio of positive surgical margins to nerve bundles spared
Time frame: 1 month
EPE detection
Time frame: 1 month
Incontinence bother
Time frame: 18 months
Incontinence: using 0-1 pads per day
Time frame: 18 months
Urgency/frequency
Time frame: 18 months
Erectile dysfunction: ability to achieve erection sufficient for penetration
Time frame: 18 months
Overall mental and physical health
Time frame: 18 months
Surgical margins
Time frame: 1 month
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 31 Jan 2025.
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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.
Clinton Bahler, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PSMA-PET and SOC MRI and SOC MRI in people with Prostate Cancer, run by Five Eleven Pharma, Inc. 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 9 inclusion and 3 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 31 Jan 2025. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jennifer Lehman (317-274-1791, jgeck@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IIEF-EF sub scale score (time frame: 1 month). The study lists 5 primary outcomes in all. 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 31 Jan 2025.