Prostate Cancer RecurrentPhase 1/2NCT03444844
Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer
A Phase 1/2 study testing Ga-68 P16-093 PET/CT scan in people with Prostate Cancer Recurrent and Prostate Cancer, run by Five Eleven Pharma, Inc. at 1 site in United States.
Trial summary
Initial performance of Ga-68-P16-093 in prostate cancer patients including dosimetry and preliminary efficacy evaluation in BCR patients, and correlation of Ga-68-P16-093 uptake with tissue histopathology in intermediate to high risk primary prostate cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Recurrent, Prostate Cancer
- What is being tested?
- Ga-68 P16-093 PET/CT scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2018to Jul 2022
- Phase
- Phase 1/2
- 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
- Male ≥ 18 years of age
- Prostate cancer patients presenting with rising PSA after radical prostatectomy for treatment if primary disease.
- PSA ≥ 0.2 ng/mL
- Patients must give informed consent for the research study, and agree to allow investigator access to clinical results following treatment plan implementation such as description of the treatment plan and PSA values following implementation of treatment plan as part of standard care, typically determined 3-4 months after treatment.
- Male ≥ 18 years of age
- Histologically confirmed prostate cancer with following Gleason scoring at biopsy:
Show all 10Show fewer
- Gleason ≥ 4+3 OR
- Gleason 3+4 with >30% pattern 4 or ≥3 cores positive
- Scheduled for radical prostatectomy (expected to occur within 60-days of scanning)
- Patients must give informed consent for the research study, and agree to allow investigator access to the clinical results such as SOC imaging (mpMRI, e.g.) for surgical planning if done, or biopsy data following prostatectomy including lymph node dissection biopsy data, if available.
Who cannot join
- Inability to give informed consent.
- Patient is unable to tolerate remaining still on the bed of the PET camera, due to physical limitations or claustrophobia.
- Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Clinical Investigators, 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
Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Official title: Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer Patients With Intermediate/High Risk Primary Disease or Biochemical Recurrence After Treatment
Initial performance of Ga-68-P16-093 in prostate cancer patients including dosimetry and preliminary efficacy evaluation in BCR patients, and correlation of Ga-68-P16-093 uptake with tissue histopathology in intermediate to high risk primary prostate cancer patients.
- Conditions
- Prostate Cancer Recurrent, Prostate Cancer
- Being tested
- Ga-68 P16-093 PET/CT 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.
Ga-68 P16-093 PET/CT scanDrug
Also called PSMA-93, HBED-CC-PHENOXY-PSMA, PSMA-093, Ga-68-P16-093
IV injection followed by PET/CT scanning
| Study group | Role | What they receive |
|---|---|---|
| Biochemical recurrent prostate cancer | Experimental | IV injection of 2 - 6 mCi of Ga-68 P16-093 followed by whole body PET/CT scanning (pelvis to shoulders) for ~ 60 min (~150 min for first 10 patients/dosimetry) starting immediately after injection.
A contrast CT scan follows PET scan. Receives: Drug: Ga-68 P16-093 PET/CT scan |
| Intermediate/High Risk primary prostate cancer | Experimental | IV injection of 2 - 6 mCi of Ga-68 P16-093 followed by list mode PET/CT scanning using a fixed FOV including the pelvis area for ~ 50 min. Receives: Drug: Ga-68 P16-093 PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Ga-68-P16-093 in BCR
We will compare the number and location of metastatic lesions apparently detected by 68Ga-P16-093 with the number and location of lesions detected by standard-of-care imaging. Sensitivity of the 68Ga-P16-093 PET procedure will be estimated based on the number of subjects in whom a site of disease is identified by the imaging procedure. Scans will also be reconstructed summing passes 1-5, passes 2-5, passes 3-5, and passes 1-2 to assess how image quality varies with chosen framing.
Measured: 2 weeks
The proportion of patients for whom Ga-18-P16-093 PET/CT changes treatment through detection of lesions
Change in management will be based on physician questionnaires including confirmation of actual treatment.
Measured: 4 months
Sensitivity and Specificity of Ga-68-P16-093 in primary PCa
We will estimate the sensitivity and specificity of the 68Ga-P16-093 PET imaging by comparing the PET SUV values and whole-mount pathology findings on a sextant basis (6 sextants per subject x 10 subjects). Images will be evaluated from ~ 5 min to 60 minutes of scanning in 5-10 minutes up to 45 min frames.
Measured: 2-60 days following PET/CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start10 May 2018
- Primary completion27 Oct 2020
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Five Eleven Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Mark Green, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444844
- Sponsor's protocol ID
- IU-1711061247
- Status last verified
- Apr 2022
- First submitted
- 19 Feb 2018
- Last updated
- 2 May 2022
- 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 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer Patients With Intermediate/High Risk Primary Disease or Biochemical Recurrence After Treatment
- ClinicalTrials.gov ID
- NCT03444844
- Acronym / sponsor ID
- IU-1711061247
- Conditions
- Prostate Cancer Recurrent, Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Five Eleven Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Study start
- 10 May 2018 (actual)
- Primary completion
- 27 Oct 2020 (actual)
- Study completion
- Jul 2022 (estimated)
- First posted
- 23 Feb 2018 (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.
Initial performance of Ga-68-P16-093 in prostate cancer patients including dosimetry and preliminary efficacy evaluation in BCR patients, and correlation of Ga-68-P16-093 uptake with tissue histopathology in intermediate to high risk primary prostate cancer patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biochemical recurrent prostate cancer | Experimental | Drug: Ga-68 P16-093 PET/CT scanIV injection of 2 - 6 mCi of Ga-68 P16-093 followed by whole body PET/CT scanning (pelvis to shoulders) for ~ 60 min (~150 min for first 10 patients/dosimetry) starting immediately after injection. A contrast CT scan follows PET scan. |
| Intermediate/High Risk primary prostate cancer | Experimental | Drug: Ga-68 P16-093 PET/CT scanIV injection of 2 - 6 mCi of Ga-68 P16-093 followed by list mode PET/CT scanning using a fixed FOV including the pelvis area for ~ 50 min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male ≥ 18 years of age
- Prostate cancer patients presenting with rising PSA after radical prostatectomy for treatment if primary disease.
- PSA ≥ 0.2 ng/mL
- Patients must give informed consent for the research study, and agree to allow investigator access to clinical results following treatment plan implementation such as description of the treatment plan and PSA values following implementation of treatment plan as part of standard care, typically determined 3-4 months after treatment.
- Male ≥ 18 years of age
Key exclusion criteria (3 listed)
- Inability to give informed consent.
- Patient is unable to tolerate remaining still on the bed of the PET camera, due to physical limitations or claustrophobia.
- Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Clinical Investigators, 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 |
|---|---|---|
| Ga-68 P16-093 PET/CT scanAlso: PSMA-93, HBED-CC-PHENOXY-PSMA, PSMA-093, Ga-68-P16-093IV injection followed by PET/CT scanning | Drug | Biochemical recurrent prostate cancer, Intermediate/High Risk primary prostate cancer |
Primary outcome
Sensitivity of Ga-68-P16-093 in BCR
Time frame: 2 weeks
We will compare the number and location of metastatic lesions apparently detected by 68Ga-P16-093 with the number and location of lesions detected by standard-of-care imaging. Sensitivity of the 68Ga-P16-093 PET procedure will be estimated based on the number of subjects in whom a site of disease is identified by the imaging procedure. Scans will also be reconstructed summing passes 1-5, passes 2-5, passes 3-5, and passes 1-2 to assess how image quality varies with chosen framing.
The proportion of patients for whom Ga-18-P16-093 PET/CT changes treatment through detection of lesions
Time frame: 4 months
Change in management will be based on physician questionnaires including confirmation of actual treatment.
Sensitivity and Specificity of Ga-68-P16-093 in primary PCa
Time frame: 2-60 days following PET/CT scan
We will estimate the sensitivity and specificity of the 68Ga-P16-093 PET imaging by comparing the PET SUV values and whole-mount pathology findings on a sextant basis (6 sextants per subject x 10 subjects). Images will be evaluated from ~ 5 min to 60 minutes of scanning in 5-10 minutes up to 45 min frames.
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 2 May 2022.
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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.
Mark Green, PhD 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 1/2 study testing Ga-68 P16-093 PET/CT scan in people with Prostate Cancer Recurrent and 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 10 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: under way, not looking for participants, as of the sponsor's last update on 2 May 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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 Ga-68-P16-093 in BCR (time frame: 2 weeks). The study lists 3 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 2 May 2022.