Prostate CancerPhase 2NCT04936334
The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer
A Phase 2 study testing 68Ga-PSMA-11 PET Scan in people with Prostate Cancer, run by Clinton Bahler at 1 site in United States.
Trial summary
Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard). Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 68Ga-PSMA-11 PET Scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2021to 19 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 1. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. Prostate pathology results consistent with:
- > 3 cores of Gleason 3+4 or
- NCCN unfavorable intermediate risk or
- NCCN high-risk or
- NCCN very-high risk 3. Scheduled for standard of care MRI or has recently completed standard of care MRI (within 6 months).
- Willing and able to lie still for approximately 50 minutes in an enclosed space for the PET/CT and MRI
Who cannot join
- 1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
- 2. Does not meet safety criteria for MRI scan (e.g. metal implant that could affect prostate imaging).
- 3. 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.
United States1 site
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: The Role of 68Ga-PSMA-11 PET in Surgery Guidance in Prostate Cancer: A Prospective Pilot Trial
Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard).
Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4).
Directly compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments.
Assess quality of life changes from preoperative baseline.
- Conditions
- Prostate Cancer
- Being tested
- 68Ga-PSMA-11 PET Scan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PSMA-11 PET ScanDiagnostic test
Patients will undergo injection of 68Ga-PSMA-11 at the time of their pre treatment PSMA PET scan and followed until 12 months post surgery.
| Study group | Role | What they receive |
|---|---|---|
| Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy | Experimental | 1. Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo injection of 68Ga-PSMA-11 at the time of their pre-treatment PSMA PET. Followed until 12 mo post surgery Receives: Diagnostic Test: 68Ga-PSMA-11 PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension
Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles
Measured: The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery.
Specificity of PSMA-PET and MRI
Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard.
Measured: Pre-surgery prediction.
Secondary outcomes (1)
1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET
Rate of treatment changes
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start11 Jun 2021
- Primary completion18 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results informs treatment decisions versus the treatment decisions with only MRI knowledge.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinton Bahler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Clinton Bahler, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936334
- Sponsor's protocol ID
- IUSCCC-0760
- Status last verified
- Aug 2023
- First submitted
- 11 Jun 2021
- Last updated
- 3 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bahler CD, Tachibana I, Tann M, Collins K, Swensson JK, Green MA, Mathias CJ, Tong Y, Yong C, Boris RS, Brocken E, Hutchins GD, Sims JB, Hill DV, Smith N, Ferari C, Love H, Koch MO. Comparing Magnetic Resonance Imaging and Prostate-Specific Membrane Antigen-Positron Emission Tomography for Prediction of Extraprostatic Extension of Prostate Cancer and Surgical Guidance: A Prospective Nonrandomized Clinical Trial. J Urol. 2024 Aug;212(2):290-298. doi: 10.1097/JU.0000000000004032. Epub 2024 May 24.
PubMed 38785259
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 68Ga-PSMA-11 PET in Surgery Guidance in Prostate Cancer: A Prospective Pilot Trial
- ClinicalTrials.gov ID
- NCT04936334
- Acronym / sponsor ID
- IUSCCC-0760
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Clinton BahlerUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard).
Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4).
Directly compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments.
Assess quality of life changes from preoperative baseline.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results informs treatment decisions versus the treatment decisions with only MRI knowledge.
| Arm | Type | Receives |
|---|---|---|
| Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy | Experimental | Diagnostic Test: 68Ga-PSMA-11 PET Scan1. Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo injection of 68Ga-PSMA-11 at the time of their pre-treatment PSMA PET. Followed until 12 mo post surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. Prostate pathology results consistent with:
- Willing and able to lie still for approximately 50 minutes in an enclosed space for the PET/CT and MRI
Key exclusion criteria (3 listed)
- 1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
- 2. Does not meet safety criteria for MRI scan (e.g. metal implant that could affect prostate imaging).
- 3. 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 |
|---|---|---|
| 68Ga-PSMA-11 PET ScanPatients will undergo injection of 68Ga-PSMA-11 at the time of their pre treatment PSMA PET scan and followed until 12 months post surgery. | Diagnostic test | Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy |
Primary outcome
Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension
Time frame: The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery.
Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles
Specificity of PSMA-PET and MRI
Time frame: Pre-surgery prediction.
Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard.
1 secondary outcome
1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET
Time frame: 60 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38785259Bahler CD, Tachibana I, Tann M, Collins K, Swensson JK, Green MA, Mathias CJ, Tong Y, Yong C, Boris RS, Brocken E, Hutchins GD, Sims JB, Hill DV, Smith N, Ferari C, Love H, Koch MO. Comparing Magnetic Resonance Imaging and Prostate-Specific Membrane Antigen-Positron Emission Tomography for Prediction of Extraprostatic Extension of Prostate Cancer and Surgical Guidance: A Prospective Nonrandomized Clinical Trial. J Urol. 2024 Aug;212(2):290-298. doi: 10.1097/JU.0000000000004032. Epub 2024 May 24.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 68Ga-PSMA-11 PET Scan in people with Prostate Cancer, run by Clinton Bahler 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 6 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: finished, as of the sponsor's last update on 3 Aug 2023. 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?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension (time frame: The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04936334, which also lists 1 linked publication.
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 3 Aug 2023.