Prostate CancerPhase 2PSMA PETNCT02611882
Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer Patients
A Phase 2 study testing Ga-68 labeled HBED-CC PSMA, Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT) and Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI) in people with Prostate Cancer, run by Thomas Hope at 1 site in United States.
Trial summary
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate… 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 HBED-CC PSMA, Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT) and Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2015to 24 Oct 2016
- 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
- Known prostate cancer with a clinical concern for the presence of metastatic disease as delineated below:
- Treatment naïve patients with one of the following risk factors: CAPRA (Cancer of the Prostate Risk Assessment) score ≥ 5, Prostate-specific antigen (PSA) ≥ 15 ng/mL and/or Gleason score ≥ 4+4.
- Patients with biochemical recurrence after prostatectomy or radiation therapy with a PSA doubling time less than 12 months.
- These patients may have received androgen deprivation therapy prior to imaging.
- Patients with castrate resistant prostate cancer with progressive disease as defined by Prostate Cancer Clinical Trials Working Group (PCWG2) criteria (27).
- Patients with castrate resistant prostate cancer can be either on treatment or off treatment
Show all 9Show fewer
- Age > 18.
- Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
- Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
- Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94107
About this study
Official title: Evaluation of Gallium-68 HBED-CC-PSMA Imaging in Prostate Cancer Patients
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate cancer.
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 HBED-CC PSMA in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the HBED-CC PSMA compound, so that this agent will become available for clinical imaging in prostate cancer patients.
This compound has been shown to be superior to choline based PET agents for the staging of prostate cancer, both Carbon-11 and Fluorine-18 compounds. But this compound was not patented and therefore no company or private entity will make the investment required to bring HBED-CC PSMA to market. In the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future FDA approval.
This study focuses on three patients populations that are imaged. In the pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis. In the biochemical recurrence population, the primary objective is to determine the sensitivity of recurrence location. In the castrate resistant prostate cancer population the primary objective is to determine if PSMA PET detects more metastatic lesions than conventional imaging.
- Conditions
- Prostate Cancer
- Being tested
- Ga-68 labeled HBED-CC PSMA, Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT), Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (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.
Ga-68 labeled HBED-CC PSMADrug
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
The imaging agent (Ga-68 HBED-CC PSMA) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET/CT imaging. The one-time nominal injected dose will be 3 to 7 millicurie (mCi) containing 10 - 25 μg Ga-68 HBED-CC PSMA.
Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT)Device
Also called PET/CT
Patient shall begin imaging between 55 and 70 minutes after the injection of the radiopharmaceutical. A PET/CT scan includes two parts: a PET scan and a CT scan. The CT portion of the scan produces a 3-D image that shows a patient's anatomy. The PET scan demonstrates function and what's occurring on a cellular level. The PET scan is unique because it images the radiation emitted from the patient while the CT records anatomical x-rays, showing the same area from another perspective
Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI)Device
Also called PET/MRI
Patient shall begin imaging between 55 and 70 minutes after the injection of the radiopharmaceutical. A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. Coverage for the scan will extend from the patients vertex through the mid thighs. We will use 4 minute acquisitions per bed position for PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| High-risk prostate cancer pre-prostatectomy (preRP) population | Experimental | Patients with high-risk prostate cancer pre-prostatectomy.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Receives: Drug: Ga-68 labeled HBED-CC PSMA; Device: Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT); Device: Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI) |
| Biochemical Recurrence (BCR) | Experimental | Patients with prostate cancer with biochemical recurrence
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Receives: Drug: Ga-68 labeled HBED-CC PSMA; Device: Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT); Device: Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI) |
| Castrate Resistant Prostate cancer (CRCP) population | Experimental | Patients with castrate resistant prostate cancer.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Receives: Drug: Ga-68 labeled HBED-CC PSMA; Device: Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT); Device: Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastases
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true positive rate will be calculated with the corresponding 95% confidence interval.
Measured: 1 day
Specificity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
Measured: 1 day
Positive Predictive Value (PPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
Measured: 1 day
Negative Predictive Value (NPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
Measured: one month
Secondary outcomes (2)
Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR Group
68Ga-labeled prostate-specific membrane antigen 11 (Ga68-PSMA-11) PET positivity rate by prostate-specific antigen (PSA) level is calculated by the number of positive reads divided by the total number of patients in the BCR Group per PSA value quintile (Detection rate (d) = total number of positive reads (t)/ total number of participants (N)).
Measured: Up to 1 year
Number of Patients in Biochemical Recurrence (BCR) Group Who Had a Reported Change in Medical Management
Change in participant medical management was determined based on the results of surveys given to each participant's treating physician. Results of the survey were categorized as a major change in participant's medical management, a minor change in participant's medical management, no change to participant's medical management, or change to participant's medical management is unknown. These categories were developed based on a predetermined categorization schema.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study start18 Dec 2015
- Primary completion24 Oct 2016
- Study completion24 Oct 2016
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 (4)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Hope
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Hope, University of California, San Francisco
- Investigators
- Thomas Hope, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611882
- Sponsor's protocol ID
- 15554
- Other IDs
- NCI-2018-00037
- Acronym
- PSMA PET
- Status last verified
- Nov 2020
- First submitted
- 29 Sep 2015
- Last updated
- 22 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lawhn-Heath C, Flavell RR, Behr SC, Yohannan T, Greene KL, Feng F, Carroll PR, Hope TA. Single-Center Prospective Evaluation of 68Ga-PSMA-11 PET in Biochemical Recurrence of Prostate Cancer. AJR Am J Roentgenol. 2019 Aug;213(2):266-274. doi: 10.2214/AJR.18.20699. Epub 2019 Apr 30.
PubMed 31039025Djaileb L, Armstrong WR, Thompson D, Gafita A, Farolfi A, Rajagopal A, Grogan TR, Nguyen K, Benz MR, Hotta M, Barbato F, Ceci F, Schwarzenbock SM, Unterrainer M, Zacho HD, Juarez R, Cooperberg M, Carroll P, Washington S, Reiter RE, Eiber M, Herrmann K, Fendler WP, Czernin J, Hope TA, Calais J. Presurgical 68Ga-PSMA-11 Positron Emission Tomography for Biochemical Recurrence Risk Assessment: A Follow-up Analysis of a Multicenter Prospective Phase 3 Imaging Trial. Eur Urol. 2023 Dec;84(6):588-596. doi: 10.1016/j.eururo.2023.06.022. Epub 2023 Jul 21.
PubMed 37482512Hope TA, Eiber M, Armstrong WR, Juarez R, Murthy V, Lawhn-Heath C, Behr SC, Zhang L, Barbato F, Ceci F, Farolfi A, Schwarzenbock SM, Unterrainer M, Zacho HD, Nguyen HG, Cooperberg MR, Carroll PR, Reiter RE, Holden S, Herrmann K, Zhu S, Fendler WP, Czernin J, Calais J. Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial. JAMA Oncol. 2021 Nov 1;7(11):1635-1642. doi: 10.1001/jamaoncol.2021.3771.
PubMed 34529005Hope TA, Aggarwal R, Chee B, Tao D, Greene KL, Cooperberg MR, Feng F, Chang A, Ryan CJ, Small EJ, Carroll PR. Impact of 68Ga-PSMA-11 PET on Management in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2017 Dec;58(12):1956-1961. doi: 10.2967/jnumed.117.192476. Epub 2017 May 18.
PubMed 28522741
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gallium-68 HBED-CC-PSMA Imaging in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT02611882
- Acronym / sponsor ID
- PSMA PET / 15554
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Thomas HopeUniversity, hospital or other
- Study start
- 18 Dec 2015 (actual)
- Primary completion
- 24 Oct 2016 (actual)
- Study completion
- 24 Oct 2016 (actual)
- First posted
- 23 Nov 2015 (estimated)
- Results
- Posted 22 Dec 2020
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 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate cancer.
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 HBED-CC PSMA in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the HBED-CC PSMA compound, so that this agent will become available for clinical imaging in prostate cancer patients.
This compound has been shown to be superior to choline based PET agents for the staging of prostate cancer, both Carbon-11 and Fluorine-18 compounds. But this compound was not patented and therefore no company or private entity will make the investment required to bring HBED-CC PSMA to market. In the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future FDA approval.
This study focuses on three patients populations that are imaged. In the pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis. In the biochemical recurrence population, the primary objective is to determine the sensitivity of recurrence location. In the castrate resistant prostate cancer population the primary objective is to determine if PSMA PET detects more metastatic lesions than conventional imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-risk prostate cancer pre-prostatectomy (preRP) population | Experimental | Drug: Ga-68 labeled HBED-CC PSMA, Device: Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT), Device: Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI)Patients with high-risk prostate cancer pre-prostatectomy. Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. |
| Biochemical Recurrence (BCR) | Experimental | Drug: Ga-68 labeled HBED-CC PSMA, Device: Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT), Device: Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI)Patients with prostate cancer with biochemical recurrence Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. |
| Castrate Resistant Prostate cancer (CRCP) population | Experimental | Drug: Ga-68 labeled HBED-CC PSMA, Device: Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT), Device: Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI)Patients with castrate resistant prostate cancer. Patients receive Ga-68-HBED-CC-PSMA 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 (9 listed)
- Known prostate cancer with a clinical concern for the presence of metastatic disease as delineated below:
- Age > 18.
- Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
- Ability to understand a written informed consent document, and the willingness to sign it.
Key exclusion criteria (3 listed)
- Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
- Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
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 HBED-CC PSMAAlso: 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-CCThe imaging agent (Ga-68 HBED-CC PSMA) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET/CT imaging. The one-time nominal injected dose will be 3 to 7 millicurie (mCi) containing 10 - 25 μg Ga-68 HBED-CC PSMA. | Drug | Biochemical Recurrence (BCR), Castrate Resistant Prostate cancer (CRCP) population, High-risk prostate cancer pre-prostatectomy (preRP) population |
| Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT)Also: PET/CTPatient shall begin imaging between 55 and 70 minutes after the injection of the radiopharmaceutical. A PET/CT scan includes two parts: a PET scan and a CT scan. The CT portion of the scan produces a 3-D image that shows a patient's anatomy. The PET scan demonstrates function and what's occurring on a cellular level. The PET scan is unique because it images the radiation emitted from the patient while the CT records anatomical x-rays, showing the same area from another perspective | Device | Biochemical Recurrence (BCR), Castrate Resistant Prostate cancer (CRCP) population, High-risk prostate cancer pre-prostatectomy (preRP) population |
| Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI)Also: PET/MRIPatient shall begin imaging between 55 and 70 minutes after the injection of the radiopharmaceutical. A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. Coverage for the scan will extend from the patients vertex through the mid thighs. We will use 4 minute acquisitions per bed position for PET imaging. | Device | Biochemical Recurrence (BCR), Castrate Resistant Prostate cancer (CRCP) population, High-risk prostate cancer pre-prostatectomy (preRP) population |
Primary outcome
Sensitivity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastases
Time frame: 1 day
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true positive rate will be calculated with the corresponding 95% confidence interval.
Specificity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
Time frame: 1 day
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
Positive Predictive Value (PPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
Time frame: 1 day
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
Negative Predictive Value (NPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
Time frame: one month
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
2 secondary outcomes
Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR Group
Time frame: Up to 1 year
Number of Patients in Biochemical Recurrence (BCR) Group Who Had a Reported Change in Medical Management
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31039025Lawhn-Heath C, Flavell RR, Behr SC, Yohannan T, Greene KL, Feng F, Carroll PR, Hope TA. Single-Center Prospective Evaluation of 68Ga-PSMA-11 PET in Biochemical Recurrence of Prostate Cancer. AJR Am J Roentgenol. 2019 Aug;213(2):266-274. doi: 10.2214/AJR.18.20699. Epub 2019 Apr 30.
- Derived from this study: PubMed 37482512Djaileb L, Armstrong WR, Thompson D, Gafita A, Farolfi A, Rajagopal A, Grogan TR, Nguyen K, Benz MR, Hotta M, Barbato F, Ceci F, Schwarzenbock SM, Unterrainer M, Zacho HD, Juarez R, Cooperberg M, Carroll P, Washington S, Reiter RE, Eiber M, Herrmann K, Fendler WP, Czernin J, Hope TA, Calais J. Presurgical 68Ga-PSMA-11 Positron Emission Tomography for Biochemical Recurrence Risk Assessment: A Follow-up Analysis of a Multicenter Prospective Phase 3 Imaging Trial. Eur Urol. 2023 Dec;84(6):588-596. doi: 10.1016/j.eururo.2023.06.022. Epub 2023 Jul 21.
- Derived from this study: PubMed 34529005Hope TA, Eiber M, Armstrong WR, Juarez R, Murthy V, Lawhn-Heath C, Behr SC, Zhang L, Barbato F, Ceci F, Farolfi A, Schwarzenbock SM, Unterrainer M, Zacho HD, Nguyen HG, Cooperberg MR, Carroll PR, Reiter RE, Holden S, Herrmann K, Zhu S, Fendler WP, Czernin J, Calais J. Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial. JAMA Oncol. 2021 Nov 1;7(11):1635-1642. doi: 10.1001/jamaoncol.2021.3771.
- Derived from this study: PubMed 28522741Hope TA, Aggarwal R, Chee B, Tao D, Greene KL, Cooperberg MR, Feng F, Chang A, Ryan CJ, Small EJ, Carroll PR. Impact of 68Ga-PSMA-11 PET on Management in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2017 Dec;58(12):1956-1961. doi: 10.2967/jnumed.117.192476. Epub 2017 May 18.
- 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 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 study testing Ga-68 labeled HBED-CC PSMA, Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT) and Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI) in people with Prostate Cancer, run by Thomas Hope 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: finished, as of the sponsor's last update on 22 Dec 2020. 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 22 Dec 2020). 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 Ga-68 HBED-CC PSMA for Detection of Nodal Metastases (time frame: 1 day). The study lists 4 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 NCT02611882, which also lists 4 linked publications.
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 22 Dec 2020.