Castration-Resistant Prostate CarcinomaPhase 2NCT04716725
68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer
A Phase 2 study testing 68Ga-PSMA-11 and Positron Emission Tomography (PET) in people with Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, run by Thomas Hope at 1 site in United States.
Trial summary
This phase II trial studies the use of 68Ga-PSMA-11 positron emission tomography (PET) in diagnosing patients with prostate cancer that continues to grow despite the surgical removal of the testes or medical intervention to block androgen production (castration resistant), and has spread to other places in the body… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8
- What is being tested?
- 68Ga-PSMA-11 and Positron Emission Tomography (PET)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2021to 30 Apr 2025
- 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
- Sub-cohort A1: Patients must have baseline evaluations performed within 12 weeks prior to the start of systemic therapy.
- Sub-cohort A2: Patients must meet all the following requirements:
- Have had a baseline pre-treatment 68Ga-PSMA-11 PET scan and PSA measurement performed within 12 weeks prior to the start of current systemic therapy.
- Able to have an on-treatment 68Ga-PSMA-11 PET and a PSA measurement within 16 weeks (+/- 8 weeks) after the start of current systemic therapy.
- Note: The screening period for sub-cohort A2 is within 24 weeks after the patient started their current systemic therapy.
- Patients must have progressive castration resistant prostate cancer, according to PCWG3 criteria.
Show all 16Show fewer
- Patients must have planned initiation of systemic treatment (sub-cohort A1), or ongoing systemic treatment (sub-cohort A2) for castration resistant prostate cancer within 12 weeks of baseline Ga-PSMA PET.
- Patients must have at least one metastatic lesion with PSMA uptake at or above the blood pool on their baseline PSMA PET scan.
- The patient must be able and willing to comply with study procedures and provide signed and dated informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patient must be Aged 18 years or older at the time of study entry.
- Patients who undergo optional metastatic tumor biopsy following completion of baseline Ga-PSMA PET must additionally meet all of the following criteria:
- Presence of one or more metastases by standard radiographic scans that is safely accessible to tumor biopsy in the judgment of treating clinician and/or Interventional Radiology.
- No history of radiation therapy to the target metastatic lesion selected for tumor biopsy.
- No contra-indication to biopsy including uncontrolled bleeding diathesis.
- Platelets > 75,000/ul and prothrombin time (PT) or institution normalized ratio (INR) and a partial thromboplastin time (PTT) < 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy.
Who cannot join
- Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
- Patients with any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
- Patients with any contra-indication to magnetic resonance imaging (MRI) (e.g. pacemaker placement, severe claustrophobia) Note: The exclusion criteria above (3) is only applicable for patients scheduled for a Positron Emission Tomography (PET) MRI (PET/MRI).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: A Phase 2 Study of 68Ga-PSMA-11 PET in Patients With Metastatic Castration Resistant Prostate Cancer
This phase II trial studies the use of 68Ga-PSMA-11 positron emission tomography (PET) in diagnosing patients with prostate cancer that continues to grow despite the surgical removal of the testes or medical intervention to block androgen production (castration resistant), and has spread to other places in the body (metastatic). 68Ga- PSMA-11 is a new imaging agent that may help get more detailed pictures of the tumor. This trial aims to see whether using 68Ga-PSMA-11 PET scans may help doctors learn more about where disease is located in the body.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine whether the percent change from baseline to 16 weeks (+/- 8 weeks) in maximum standard uptake value (SUVmax) averaged across up to 16 lesions per patient (SUVmax-ave) is associated with >= 50% decline from baseline in serum prostate specific antigen (PSA50) response.
SECONDARY OBJECTIVES:
- To determine whether the percent change from baseline in SUVmax-ave on PSMA PET is associated with time-to-event endpoints including PSA progression-free survival and overall survival.
II. To determine whether the percent change from baseline in SUVmax on PSMA PET is associated with objective response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 on a per-lesion basis among measurable soft tissue lesions present at baseline.
EXPLORATORY (CORRELATIVE) OBJECTIVES:
- To descriptively characterize the histologic, transcriptional, and genomic features of PSMA low/negative lesions among patients who undergo paired optional metastatic tumor biopsy.
II. To descriptively characterize the relationship between SUVmax-ave on baseline Ga-PSMA PET with optional baseline fludeoxyglucose F-18 (FDG)-PET.
III. To determine whether heterogeneity of PSMA expression on baseline Ga-PSMA PET is associated with overall survival.
IV. To descriptively characterize the patterns of PSMA expression at the time of disease progression among patients who undergo optional PSMA PET.
- To determine whether the percent change from baseline in PSMA PET is associated with PSA50 response among subgroups of patients defined by treatment modality received, including androgen receptor (AR) targeting treatment, PSMA-targeting radioligand therapy, cytotoxic chemotherapy, and immunotherapy.
OUTLINE:
Patients receive gallium Ga 68-PSMA-11 intravenously (IV) and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.
After progression or study completion, patients are followed up every 3 months for up to 24 months
- Conditions
- Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
- Being tested
- 68Ga-PSMA-11, Positron Emission Tomography (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.
68Ga-PSMA-11Drug
Also called 68Ga Prostate-specific Membrane Antigen (PSMA) 11, Gallium Ga-68 gozetotide, Gallium-68 PSMA, Gallium Ga 68 PSMA-11
Given IV
Positron Emission Tomography (PET)Procedure or surgery
Also called PET, PET Scan
Undergo PET
| Study group | Role | What they receive |
|---|---|---|
| Experimental (68Ga-PSMA-11 PET) | Experimental | Patients receive gallium 68Ga-PSMA-11 IV and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression. Receives: Drug: 68Ga-PSMA-11; Procedure: Positron Emission Tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Maximum Standard Uptake Value (SUVmax)
The mean SUVmax and standard deviation across the primary tumor and the 5 largest lesions in each of three metastatic sites (nodal, visceral and osseous; for a maximum of 16 lesions per patient) will be descriptively reported.
Measured: Baseline, and up to 16 weeks after initiation of therapy
Median SUVmax
The median and range of SUVmax across the primary tumor and the 5 largest lesions in each of three metastatic sites (nodal, visceral and osseous; for a maximum of 16 lesions per patient) will be descriptively reported.
Measured: Baseline, and up to 16 weeks after initiation of therapy
Percentage of Participants Who Progressed by Prostate-specific Antigen (PSA) Response Group
The percent of participants who fall into the PSA50 responders vs. non-responders based on PSMA treatment response criteria (PPP) for progression status will be reported. PPP uses 3 different criteria to determine response: 1) Appearance of 2 or more new PSMA positive distant lesions, 2) Appearance of 1 new PSMA positive lesion plus consistent clinical and/or laboratory data and recommended confirmation by biopsy or correlative imaging within 3 months of PSMA PET, and 3) Increase in size or PSMA uptake of 1 or more existing lesions by 30% plus consistent clinical and/or laboratory data and/or confirmation by biopsy or correlative imaging within 3 months of PSMA PET.
Measured: Baseline, and up to 16 weeks after initiation of therapy
Secondary outcomes (3)
Progression Free Survival (PFS) by PET Response Group
The study cohort will be dichotomized by participants who fall into the responders vs. non-responders (progressed vs not progressed) based on PSMA PET response criteria (PPP) for progression status will be reported. PPP uses 3 different criteria to determine response: 1) Appearance of 2 or more new PSMA positive distant lesions, 2) Appearance of 1 new PSMA positive lesion plus consistent clinical and/or laboratory data and recommended confirmation by biopsy or correlative imaging within 3 months of PSMA PET, and 3) Increase in size or PSMA uptake of 1 or more existing lesions by 30% plus consistent clinical and/or laboratory data and/or confirmation by biopsy or correlative imaging within 3 months of PSMA PET. PSA progression-free will be defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3). The median PFS in months with 95% confidence interval will be reported.
Measured: Up to 48 months
Objective Response by PET Response Group
The study cohort will be dichotomized by participants who fall into the responders vs. non-responders (progressed vs not progressed) based on PSMA PET response criteria (PPP) for progression status will be reported. PPP uses 3 different criteria to determine response: 1) Appearance of 2 or more new PSMA positive distant lesions, 2) Appearance of 1 new PSMA positive lesion plus consistent clinical and/or laboratory data and recommended confirmation by biopsy or correlative imaging within 3 months of PSMA PET, and 3) Increase in size or PSMA uptake of 1 or more existing lesions by 30% plus consistent clinical and/or laboratory data and/or confirmation by biopsy or correlative imaging within 3 months of PSMA PET. PSA progression-free will be defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3). The percentage of participants who obtained an objective response per Response Evaluation Criteria in Solid Tumors (RECIST) will be reported.
Measured: Baseline, and up to 16 weeks after initiation of therapy
Overall Survival (OS) by PET Response Group
The study cohort will be dichotomized by participants who fall into the responders vs. non-responders (progressed vs not progressed) based on PSMA PET response criteria (PPP) for progression status will be reported. PPP uses 3 different criteria to determine response: 1) Appearance of 2 or more new PSMA positive distant lesions, 2) Appearance of 1 new PSMA positive lesion plus consistent clinical and/or laboratory data and recommended confirmation by biopsy or correlative imaging within 3 months of PSMA PET, and 3) Increase in size or PSMA uptake of 1 or more existing lesions by 30% plus consistent clinical and/or laboratory data and/or confirmation by biopsy or correlative imaging within 3 months of PSMA PET. PSA progression-free will be defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3). The median OS and 95% confidence interval will be reported.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start28 Sep 2021
- Primary completion30 Sep 2023
- Study completion30 Apr 2025
Why it stopped: Low accrual
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 Castration-Resistant Prostate CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Hope
- Sponsor type
- University, hospital or other
- Collaborators
- Conquer Cancer Foundation, Gateway for Cancer Research, Prostate Cancer Foundation
- Responsible party
- Sponsor-investigator, Thomas Hope, University of California, San Francisco
- Investigators
- Ivan A de Kouchovsky, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716725
- Sponsor's protocol ID
- 209211
- Other IDs
- NCI-2020-13741
- Status last verified
- Apr 2026
- First submitted
- 15 Jan 2021
- Last updated
- 15 May 2026
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of 68Ga-PSMA-11 PET in Patients With Metastatic Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT04716725
- Acronym / sponsor ID
- 209211
- Conditions
- Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Thomas HopeUniversity, hospital or other
- Collaborators
- Conquer Cancer Foundation, Gateway for Cancer Research, Prostate Cancer Foundation
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Posted 16 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies the use of 68Ga-PSMA-11 positron emission tomography (PET) in diagnosing patients with prostate cancer that continues to grow despite the surgical removal of the testes or medical intervention to block androgen production (castration resistant), and has spread to other places in the body (metastatic). 68Ga- PSMA-11 is a new imaging agent that may help get more detailed pictures of the tumor. This trial aims to see whether using 68Ga-PSMA-11 PET scans may help doctors learn more about where disease is located in the body.
Detailed description
PRIMARY OBJECTIVE:
- To determine whether the percent change from baseline to 16 weeks (+/- 8 weeks) in maximum standard uptake value (SUVmax) averaged across up to 16 lesions per patient (SUVmax-ave) is associated with >= 50% decline from baseline in serum prostate specific antigen (PSA50) response.
SECONDARY OBJECTIVES:
- To determine whether the percent change from baseline in SUVmax-ave on PSMA PET is associated with time-to-event endpoints including PSA progression-free survival and overall survival.
II. To determine whether the percent change from baseline in SUVmax on PSMA PET is associated with objective response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 on a per-lesion basis among measurable soft tissue lesions present at baseline.
EXPLORATORY (CORRELATIVE) OBJECTIVES:
- To descriptively characterize the histologic, transcriptional, and genomic features of PSMA low/negative lesions among patients who undergo paired optional metastatic tumor biopsy.
II. To descriptively characterize the relationship between SUVmax-ave on baseline Ga-PSMA PET with optional baseline fludeoxyglucose F-18 (FDG)-PET.
III. To determine whether heterogeneity of PSMA expression on baseline Ga-PSMA PET is associated with overall survival.
IV. To descriptively characterize the patterns of PSMA expression at the time of disease progression among patients who undergo optional PSMA PET.
- To determine whether the percent change from baseline in PSMA PET is associated with PSA50 response among subgroups of patients defined by treatment modality received, including androgen receptor (AR) targeting treatment, PSMA-targeting radioligand therapy, cytotoxic chemotherapy, and immunotherapy.
OUTLINE:
Patients receive gallium Ga 68-PSMA-11 intravenously (IV) and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.
After progression or study completion, patients are followed up every 3 months for up to 24 months
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental (68Ga-PSMA-11 PET) | Experimental | Drug: 68Ga-PSMA-11, Procedure: Positron Emission Tomography (PET)Patients receive gallium 68Ga-PSMA-11 IV and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Sub-cohort A1: Patients must have baseline evaluations performed within 12 weeks prior to the start of systemic therapy.
- Sub-cohort A2: Patients must meet all the following requirements:
- Note: The screening period for sub-cohort A2 is within 24 weeks after the patient started their current systemic therapy.
- Patients must have progressive castration resistant prostate cancer, according to PCWG3 criteria.
- Patients must have planned initiation of systemic treatment (sub-cohort A1), or ongoing systemic treatment (sub-cohort A2) for castration resistant prostate cancer within 12 weeks of baseline Ga-PSMA PET.
Key exclusion criteria (3 listed)
- Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
- Patients with any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
- Patients with any contra-indication to magnetic resonance imaging (MRI) (e.g. pacemaker placement, severe claustrophobia) Note: The exclusion criteria above (3) is only applicable for patients scheduled for a Positron Emission Tomography (PET) MRI (PET/MRI).
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-11Also: 68Ga Prostate-specific Membrane Antigen (PSMA) 11, Gallium Ga-68 gozetotide, Gallium-68 PSMA, Gallium Ga 68 PSMA-11Given IV | Drug | Experimental (68Ga-PSMA-11 PET) |
| Positron Emission Tomography (PET)Also: PET, PET ScanUndergo PET | Procedure or surgery | Experimental (68Ga-PSMA-11 PET) |
Primary outcome
Mean Maximum Standard Uptake Value (SUVmax)
Time frame: Baseline, and up to 16 weeks after initiation of therapy
The mean SUVmax and standard deviation across the primary tumor and the 5 largest lesions in each of three metastatic sites (nodal, visceral and osseous; for a maximum of 16 lesions per patient) will be descriptively reported.
Median SUVmax
Time frame: Baseline, and up to 16 weeks after initiation of therapy
The median and range of SUVmax across the primary tumor and the 5 largest lesions in each of three metastatic sites (nodal, visceral and osseous; for a maximum of 16 lesions per patient) will be descriptively reported.
Percentage of Participants Who Progressed by Prostate-specific Antigen (PSA) Response Group
Time frame: Baseline, and up to 16 weeks after initiation of therapy
The percent of participants who fall into the PSA50 responders vs. non-responders based on PSMA treatment response criteria (PPP) for progression status will be reported. PPP uses 3 different criteria to determine response: 1) Appearance of 2 or more new PSMA positive distant lesions, 2) Appearance of 1 new PSMA positive lesion plus consistent clinical and/or laboratory data and recommended confirmation by biopsy or correlative imaging within 3 months of PSMA PET, and 3) Increase in size or PSMA uptake of 1 or more existing lesions by 30% plus consistent clinical and/or laboratory data and/or confirmation by biopsy or correlative imaging within 3 months of PSMA PET.
3 secondary outcomes
Progression Free Survival (PFS) by PET Response Group
Time frame: Up to 48 months
Objective Response by PET Response Group
Time frame: Baseline, and up to 16 weeks after initiation of therapy
Overall Survival (OS) by PET Response Group
Time frame: Up to 48 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- 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.
Ivan A de Kouchovsky, 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 study testing 68Ga-PSMA-11 and Positron Emission Tomography (PET) in people with Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, 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 16 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: stopped early, as of the sponsor's last update on 15 May 2026. 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 16 Oct 2024). 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?
Mean Maximum Standard Uptake Value (SUVmax) (time frame: Baseline, and up to 16 weeks after initiation of therapy). 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 15 May 2026.