Prostate CancerPhase 2NCT03429244
PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer
A Phase 2 study testing 68Ga-PSMA-11 PET-MRI in people with Prostate Cancer, run by Indiana University at 4 sites in United States.
Trial summary
The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of 68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer lesions in low and intermediate risk disease. 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-MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Apr 2019to 1 May 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
- ≥ 18 years of age
- Must provide written informed consent
- Presence of low or intermediate risk prostate cancer or at risk of having intermediate risk cancer
- Intermediate risk prostate cancer: i. Grade group 2 = 3 + 4, or ii. Grade group 3 = 4 + 3 b. At Risk of intermediate risk prostate cancer: i. 4K score ≥ 20%, or ii. Select MDx ≥ 20%, or iii. PSA Density ≥ 0.15 iv. Grade group 1= 3+3 (iv. Note: Where multiple cancer lesions are present on biopsy, it is allowable to have Gleason 8 or 9 cancer lesions if they are in addition to the intermediate risk cancer as described above.)
- Scheduled for MRI or has recently completed SOC MRI (within 6 months) for further biopsy, or surgical removal, or focal therapy.
- Willing and able to lie still for approximately 50 minutes in an enclosed space for the CT.
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).
- Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Indiana University Health North Hospital
Carmel, Indiana, 46032
Indiana University Health Hospital
Indianapolis, Indiana, 46202
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of 68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer lesions in low and intermediate risk disease.
A molecularly-targeted probe (68Ga-PSMA-11), coupled with an advanced clinical imaging system (Siemens Biograph VisionPET-CT), will improve accuracy during biopsy and staging. We propose detailed intra-lesion whole-mount pathologic analysis as the gold standard for critically assessing PSMA PET accuracy in patients undergoing surgery, and blinded PSMA PET-CT comparison with standard multi-parametric MRI (mpMRI) for patients having biopsy on active surveillance. This intensive testing of the accuracy and value of PSMA-based tracers requires our unique collaboration of surgeons, radiologists, pathologists, and imaging scientists with decades of experience and innovation.
Read the detailed description
This is a prospective, single arm, phase 2 clinical trial. This patient population will have low (1 = Gleason 3 + 3) or intermediate risk (2 = 3 + 4; 3 = 4 + 3) prostate cancer. It will also enroll those who are at high risk of significant prostate cancer (4Kscore >20%, SelectMDx >20%, PSA density >0.15). Patients will be scheduled for magnetic resonance imaging (MRI) as part of routine care for either surgical planning or for further biopsy. Following the informed consent process, patients who enroll in the study will receive a PSMA positron emission tomography (PET) study along with their standard of care (SOC) MRI on an integrated PET-MRI. Registration of PET and MRI will be done using software to generate the PET-MRI images. Patients receiving SOC MRI guided biopsy will receive additional PET guided biopsies as indicated in a single session. The sensitivity and specificity will be evaluated along with the ability of the tracer to inform the treatment planning. Patients receiving surgical removal of the prostate will have a slice-by-slice whole mount analysis to assess the sensitivity and specificity the PSMA PET.
Primary Objectives Define the accuracy of 68Ga-PSMA-11 PET-CT for detecting the clinically significant prostate cancer lesion.
Secondary Objectives Evaluate how knowledge of the PSMA-PET might inform treatment planning.
Exploratory Objectives Generate pilot data for future larger clinical trials
- Conditions
- Prostate Cancer
- Being tested
- 68Ga-PSMA-11 PET-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.
68Ga-PSMA-11 PET-MRIDiagnostic test
Patients will undergo injection of 68Ga-PSMA-11 at the time of pre-treatment MRI scan and followed until biopsy and/or surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer- men being treated with radical prostatectomy | Experimental | Men being treated for prostate cancer with radical prostatectromy were enrolled in this arm. Receives: Diagnostic Test: 68Ga-PSMA-11 PET-MRI |
| Prostate cancer- men undergoing cancer screening or active surveillance | Experimental | Men undergoing cancer screening or active surveillance were enrolled in this arm. Receives: Diagnostic Test: 68Ga-PSMA-11 PET-MRI |
| Prostate cancer- focal therapy | Experimental | Men undergoing focal therapy with high intensity focused ultrasound are in this group. Receives: Diagnostic Test: 68Ga-PSMA-11 PET-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of PSMA PET
Sensitivity and specificity for EPE using whole-mount analysis or biopsy pathology. EPE is extra-prostatic extension which means the cancer extends beyond the boundary of the prostate into adjacent muscle or fatty tissue.
Measured: 60 days
Secondary outcomes (1)
Impact of PSMA PET-CT on Treatment Plan for Surgery or Biopsy
Does the PSMA-PET change the treatment or biopsy decision. The surgeon will look at imaging prior to a procedure (prostatectomy, HIFU, or biopsy) to see if it informs the procedure steps. Does the imaging add new information about the cancer that could alter the biopsy or treatment? PSMA-PET scans were obtained in 3 different contexts as listed below (prior to prostate removal, screening for cancer or on active surveillance, and prior to focal therapy). We calculate the percentage of cases that had the treatment or followup plan altered by the investigational imaging agent.
For example, if the PET imaging showed cancer was organ confined, then the surgeon may elect to increase the nerve sparing. For the active surveillance group, if this PET imaging showed a new lesion in the prostate, when compared to ultrasound or MRI, then the biopsy may have been altered to target this new lesion. For focal therapy, the treatment could be expanded to ensure any new PET lesions are covered.
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 posted12 Feb 2018
- Study start15 Apr 2019
- Primary completion1 May 2022
- Study completion1 May 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.
- More trials run by Indiana UniversityThe 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
- 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 helps inform treatment decisions.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clinton Bahler, Indiana University
- Investigators
- Clinton Bahler, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429244
- Sponsor's protocol ID
- IUSCC-0658
- Other IDs
- 1802085219
- Status last verified
- Apr 2023
- First submitted
- 5 Feb 2018
- Last updated
- 8 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: For multi-institutional projects with data sharing agreement.
Publications
Bahler CD, Green MA, Tann MA, Swensson JK, Collins K, Alexoff D, Kung H, Brocken E, Mathias CJ, Cheng L, Hutchins GD, Koch MO. Assessing extra-prostatic extension for surgical guidance in prostate cancer: Comparing two PSMA-PET tracers with the standard-of-care. Urol Oncol. 2023 Jan;41(1):48.e1-48.e9. doi: 10.1016/j.urolonc.2022.10.003. Epub 2022 Nov 1.
PubMed 36333187
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer
- ClinicalTrials.gov ID
- NCT03429244
- Acronym / sponsor ID
- IUSCC-0658
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Posted 8 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of 68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer lesions in low and intermediate risk disease.
A molecularly-targeted probe (68Ga-PSMA-11), coupled with an advanced clinical imaging system (Siemens Biograph VisionPET-CT), will improve accuracy during biopsy and staging. We propose detailed intra-lesion whole-mount pathologic analysis as the gold standard for critically assessing PSMA PET accuracy in patients undergoing surgery, and blinded PSMA PET-CT comparison with standard multi-parametric MRI (mpMRI) for patients having biopsy on active surveillance. This intensive testing of the accuracy and value of PSMA-based tracers requires our unique collaboration of surgeons, radiologists, pathologists, and imaging scientists with decades of experience and innovation.
Detailed description
This is a prospective, single arm, phase 2 clinical trial. This patient population will have low (1 = Gleason 3 + 3) or intermediate risk (2 = 3 + 4; 3 = 4 + 3) prostate cancer. It will also enroll those who are at high risk of significant prostate cancer (4Kscore >20%, SelectMDx >20%, PSA density >0.15). Patients will be scheduled for magnetic resonance imaging (MRI) as part of routine care for either surgical planning or for further biopsy. Following the informed consent process, patients who enroll in the study will receive a PSMA positron emission tomography (PET) study along with their standard of care (SOC) MRI on an integrated PET-MRI. Registration of PET and MRI will be done using software to generate the PET-MRI images. Patients receiving SOC MRI guided biopsy will receive additional PET guided biopsies as indicated in a single session. The sensitivity and specificity will be evaluated along with the ability of the tracer to inform the treatment planning. Patients receiving surgical removal of the prostate will have a slice-by-slice whole mount analysis to assess the sensitivity and specificity the PSMA PET.
Primary Objectives Define the accuracy of 68Ga-PSMA-11 PET-CT for detecting the clinically significant prostate cancer lesion.
Secondary Objectives Evaluate how knowledge of the PSMA-PET might inform treatment planning.
Exploratory Objectives Generate pilot data for future larger clinical trials
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results helps inform treatment decisions.
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer- men being treated with radical prostatectomy | Experimental | Diagnostic Test: 68Ga-PSMA-11 PET-MRIMen being treated for prostate cancer with radical prostatectromy were enrolled in this arm. |
| Prostate cancer- men undergoing cancer screening or active surveillance | Experimental | Diagnostic Test: 68Ga-PSMA-11 PET-MRIMen undergoing cancer screening or active surveillance were enrolled in this arm. |
| Prostate cancer- focal therapy | Experimental | Diagnostic Test: 68Ga-PSMA-11 PET-MRIMen undergoing focal therapy with high intensity focused ultrasound are in this group. |
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)
- ≥ 18 years of age
- Must provide written informed consent
- Presence of low or intermediate risk prostate cancer or at risk of having intermediate risk cancer
- Scheduled for MRI or has recently completed SOC MRI (within 6 months) for further biopsy, or surgical removal, or focal therapy.
- Willing and able to lie still for approximately 50 minutes in an enclosed space for the CT.
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).
- Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's 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-MRIPatients will undergo injection of 68Ga-PSMA-11 at the time of pre-treatment MRI scan and followed until biopsy and/or surgical resection. | Diagnostic test | Prostate cancer- focal therapy, Prostate cancer- men being treated with radical prostatectomy, Prostate cancer- men undergoing cancer screening or active surveillance |
Primary outcome
Diagnostic Accuracy of PSMA PET
Time frame: 60 days
Sensitivity and specificity for EPE using whole-mount analysis or biopsy pathology. EPE is extra-prostatic extension which means the cancer extends beyond the boundary of the prostate into adjacent muscle or fatty tissue.
1 secondary outcome
Impact of PSMA PET-CT on Treatment Plan for Surgery or Biopsy
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 8 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36333187Bahler CD, Green MA, Tann MA, Swensson JK, Collins K, Alexoff D, Kung H, Brocken E, Mathias CJ, Cheng L, Hutchins GD, Koch MO. Assessing extra-prostatic extension for surgical guidance in prostate cancer: Comparing two PSMA-PET tracers with the standard-of-care. Urol Oncol. 2023 Jan;41(1):48.e1-48.e9. doi: 10.1016/j.urolonc.2022.10.003. Epub 2022 Nov 1.
- Individual participant dataSharing planned: Undecided. For multi-institutional projects with data sharing agreement.
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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.
Clinton Bahler, MD principal investigator
Indiana University
4 sites 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-MRI in people with Prostate Cancer, run by Indiana University at 4 sites 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 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 8 May 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?
Diagnostic Accuracy of PSMA PET (time frame: 60 days). 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 NCT03429244, 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 8 May 2023.