Prostate CancerPhase 2/3PSMA BCRNCT02918357
Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
A Phase 2/3 study testing Ga-68 labeled PSMA-11 PET in people with Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy. 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?
- Ga-68 labeled PSMA-11 PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2016to 21 Sep 2017
- Phase
- Phase 2/3
- 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
- Histopathological proven prostate adenocarcinoma.
- Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation
- PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,
- Confirmatory persistent PSA greater than 0.2 ng/mL
- Post-radiation therapy -ASTRO-Phoenix consensus definition
Show all 10Show fewer
- Nadir + greater than or equal to 2 ng/mL rise in PSA
- Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
- Age > 18.
- Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- Investigational therapy for prostate cancer.
- Unable to lie flat, still or tolerate a PET scan.
- Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
Read the detailed description
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.
- Conditions
- Prostate Cancer
- Being tested
- Ga-68 labeled PSMA-11 PET
- 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 labeled PSMA-11 PETDrug
Also called Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled Glu-NH-CO-NH- Lys(Ahx)-HBED-CC, Ga-68 labeled Glu-urea- Lys(Ahx)-HBED-CC, Ga-68 labeled HBED-CC PSMA
Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
| Study group | Role | What they receive |
|---|---|---|
| Ga-68 labeled PSMA-11 PET | Experimental | PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Receives: Drug: Ga-68 labeled PSMA-11 PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation
PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method.
Measured: 1 month
Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation
PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method.
Measured: 1 month
Secondary outcomes (9)
PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up
PPVs on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.
Measured: 1 month
PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up
PPVs on a per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.
Measured: 1 month
Sensitivity on a Per-patient Basis
Sensitivity, on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.
Measured: 1 month
Sensitivity on a Per-region Basis
Sensitivity, on a per-region basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.
Measured: 1 month
Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value
Detection rate was defined as proportion of 68Ga-PSMA-11 PET positive patients, independent of the reference standard stratified by PSA value (0.2-<0.5; 0.5-<1.0; 1.0-<2.0; 2.0-<5.0, and ≥5.0).
Measured: 1 month
Inter-reader Agreement Per-region
Inter-reader reproducibility for positivity at region level was reported using the Fleiss' Kappa test for multiple readers. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).
Measured: 1 month
Percentage of Participants With Change in Clinical Management
Clinical management changes were assessed using surveys of Intended Management to determine the percent change in clinical management after 68Ga-PSMA-11 PET.
Measured: Up to 1 year
Safety Assessment - Heart Rate
Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.
Measured: 1 day
Safety Assessment - Blood Pressure
Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start15 Sep 2016
- Primary completion21 Sep 2017
- Study completion21 Sep 2017
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.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Hope, University of California, San Francisco
- Investigators
- Thomas Hope, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918357
- Sponsor's protocol ID
- 165510
- Other IDs
- NCI-2018-00039
- Acronym
- PSMA BCR
- Status last verified
- Nov 2019
- First submitted
- 27 Sep 2016
- Last updated
- 2 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
- ClinicalTrials.gov ID
- NCT02918357
- Acronym / sponsor ID
- PSMA BCR / 165510
- Conditions
- Prostate Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 21 Sep 2017 (actual)
- Study completion
- 21 Sep 2017 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Posted 2 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
Detailed description
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ga-68 labeled PSMA-11 PET | Experimental | Drug: Ga-68 labeled PSMA-11 PETPSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. |
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)
- Histopathological proven prostate adenocarcinoma.
- Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
- Age > 18.
- Ability to understand a written informed consent document, and the willingness to sign it.
Key exclusion criteria (4 listed)
- Investigational therapy for prostate cancer.
- Unable to lie flat, still or tolerate a PET scan.
- Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
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 labeled PSMA-11 PETAlso: Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled Glu-NH-CO-NH- Lys(Ahx)-HBED-CC, Ga-68 labeled Glu-urea- Lys(Ahx)-HBED-CC, Ga-68 labeled HBED-CC PSMAPatients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. | Drug | Ga-68 labeled PSMA-11 PET |
Primary outcome
Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation
Time frame: 1 month
PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method.
Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation
Time frame: 1 month
PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method.
9 secondary outcomes
PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up
Time frame: 1 month
PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up
Time frame: 1 month
Sensitivity on a Per-patient Basis
Time frame: 1 month
Sensitivity on a Per-region Basis
Time frame: 1 month
Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value
Time frame: 1 month
Inter-reader Agreement Per-region
Time frame: 1 month
Percentage of Participants With Change in Clinical Management
Time frame: Up to 1 year
Safety Assessment - Heart Rate
Time frame: 1 day
Safety Assessment - Blood Pressure
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Thomas Hope, MD principal investigator
University of California, San Francisco
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 Ga-68 labeled PSMA-11 PET in people with Prostate Cancer, run by University of California, San Francisco 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 4 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 2 Dec 2019. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2019). 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?
Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation (time frame: 1 month). 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?
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 Dec 2019.