Prostate CancerPhase 3NCT03803475

Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients

A Phase 3 study testing Ga-68 labeled PSMA-11, Positron emission tomography-computed tomography (PET/CT) and Positron emission tomography-magnetic resonance imaging (PET/MRI) in people with Prostate Cancer, run by Thomas Hope at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer. 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, Positron emission tomography-computed tomography (PET/CT) and Positron emission tomography-magnetic resonance imaging (PET/MRI)
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 485 participants
Where: 1 siteUnited States
Study dates: 11 Oct 2018to 25 Aug 2020
Phase: Phase 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

Male, age >= 18.
Histopathologically proven prostate adenocarcinoma.
Concern for metastatic disease in one of the following settings:
Initial staging with intermediate to high risk prostate cancer.
Biochemical recurrence after initial therapy.
Ability to understand a written informed consent document, and the willingness to sign it.

Who cannot join

1. Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Francisco
San Francisco, California, 94143

Other trials in United States

About this study

The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.

Read the detailed description

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is 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. PET imaging will begin 50-100 minutes after injection, but may be possible in certain circumstances for imaging to be delayed due to patient workflow or equipment issues

Primary Objective:

Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

Conditions: Prostate Cancer
Being tested: Ga-68 labeled PSMA-11, Positron emission tomography-computed tomography (PET/CT), Positron emission tomography-magnetic resonance imaging (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 PSMA-11Drug
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 there is 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.
Positron emission tomography-computed tomography (PET/CT)Device
Also called PET-CT
Positron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session
Positron emission tomography-magnetic resonance imaging (PET/MRI)Device
Also called PET-MRI
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 in a single session

Study groups in NCT03803475
Study group	Role	What they receive
Ga-68 labeled PSMA-11 PET PSMA	Experimental	The imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET imaging. The injected dose will be 3 to 7 millicurie (mCi) +/- 10% of 68Ga-PSMA-11. Receives: Drug: Ga-68 labeled PSMA-11; Device: Positron emission tomography-computed tomography (PET/CT); Device: Positron emission tomography-magnetic resonance imaging (PET/MRI)

What is being measured

The primary outcome is the main question the study is designed to answer.

Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group
Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
Measured: 1 day
Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group
Detection rate is defined as the proportion of all patients who have prostate cancer located in the prostate bed and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
Measured: 1 day
Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group
Detection rate is defined as the proportion of all patients who have prostate cancer located in the pelvic nodes and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
Measured: 1 day
Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group
Detection rate is defined as the proportion of all patients who have prostate cancer located in the distant soft tissues and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
Measured: 1 day
Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group
Detection rate is defined as the proportion of all patients who have prostate cancer located in the bone (osseous lesions) and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 201825 Aug 2020

First posted14 Jan 2019
Study start11 Oct 2018
Primary completion25 Aug 2020
Study completion25 Aug 2020

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.
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 3
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 485 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03803475
Sponsor's protocol ID: 185513
Other IDs: NCI-2019-01394
Status last verified: Jul 2021
First submitted: 10 Jan 2019
Last updated: 24 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients
ClinicalTrials.gov ID: NCT03803475
Acronym / sponsor ID: 185513
Conditions: Prostate Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 485 participants (actual)
Lead sponsor: Thomas HopeUniversity, hospital or other
Study start: 11 Oct 2018 (actual)
Primary completion: 25 Aug 2020 (actual)
Study completion: 25 Aug 2020 (actual)
First posted: 14 Jan 2019 (actual)
Results: Posted 24 Aug 2021

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 Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.

Detailed description

Primary Objective:

Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

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 PSMA	Experimental	Drug: Ga-68 labeled PSMA-11, Device: Positron emission tomography-computed tomography (PET/CT), Device: Positron emission tomography-magnetic resonance imaging (PET/MRI)The imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET imaging. The injected dose will be 3 to 7 millicurie (mCi) +/- 10% of 68Ga-PSMA-11.

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)

Male, age >= 18.
Histopathologically proven prostate adenocarcinoma.
Concern for metastatic disease in one of the following settings:
Ability to understand a written informed consent document, and the willingness to sign it.

Key exclusion criteria (1 listed)

1. Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

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-11Also: 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 there is 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 PSMA
Positron emission tomography-computed tomography (PET/CT)Also: PET-CTPositron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session	Device	Ga-68 labeled PSMA-11 PET PSMA
Positron emission tomography-magnetic resonance imaging (PET/MRI)Also: PET-MRIA 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 in a single session	Device	Ga-68 labeled PSMA-11 PET PSMA

Primary outcome

Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group
Time frame: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group
Time frame: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer located in the prostate bed and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group
Time frame: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer located in the pelvic nodes and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group
Time frame: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer located in the distant soft tissues and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group
Time frame: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer located in the bone (osseous lesions) and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.

Results and safety

Results posted to the registry on 24 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ga-68 Labeled PSMA-11 PET PSMA	485	484

Primary outcome: Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group

Time frame: 1 day. Number. Unit: proportion

Measure	Ga-68 Labeled PSMA-11 PET PSMA n = 484
PSA Level of 0 to 0.19	0.38
PSA Level of 0.2 to 0.49	0.45
PSA Level of 0.5 to 0.99	0.76
PSA Level of 1 to 1.99	0.73
PSA Level of 2 to 4.99	0.82
PSA Level of 5 to maximum	0.62

Population analysed: The Number Analyzed for each Row indicates the number of participants with each detected level of PSA

Primary outcome: Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group

Time frame: 1 day. Number. Unit: proportion

Measure	Ga-68 Labeled PSMA-11 PET PSMA n = 484
PSA Level of 0 to 0.19	0.14
PSA Level of 0.2 to 0.49	0.09
PSA Level of 0.5 to 0.99	0.18
PSA Level of 1 to 1.99	0.37
PSA Level of 2 to 4.99	0.50
PSA Level of 5 to maximum	0.76

Population analysed: The Number Analyzed for each Row indicates the number of participants with each detected level of PSA

Primary outcome: Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group

Time frame: 1 day. Number. Unit: proportion

Measure	Ga-68 Labeled PSMA-11 PET PSMA n = 484
PSA Level of 0 to 0.19	0.10
PSA Level of 0.2 to 0.49	0.27
PSA Level of 0.5 to 0.99	0.51
PSA Level of 1 to 1.99	0.24
PSA Level of 2 to 4.99	0.34
PSA Level of 5 to maximum	0.37

Population analysed: The Number Analyzed for each Row indicates the number of participants with each detected level of PSA

Primary outcome: Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group

Time frame: 1 day. Number. Unit: proportion

Measure	Ga-68 Labeled PSMA-11 PET PSMA n = 484
PSA Level of 0 to 0.19	0.10
PSA Level of 0.2 to 0.49	0.09
PSA Level of 0.5 to 0.99	0.10
PSA Level of 1 to 1.99	0.18
PSA Level of 2 to 4.99	0.30
PSA Level of 5 to maximum	0.21

Population analysed: The Number Analyzed for each Row indicates the number of participants with each detected level of PSA

Adverse events

Time frame: Up to 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ga-68 Labeled PSMA-11 PET PSMA	0 of 485 (0%)	0 of 485 (0%)	0 of 485

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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?

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 1 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 24 Aug 2021. 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 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 24 Aug 2021). 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?

Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group (time frame: 1 day). The study lists 5 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 NCT03803475.

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 24 Aug 2021.