Biochemically Recurrent Prostate CarcinomaPhase 2NCT04777071
An Investigational Scan (68Ga-PSMA-11 PET) for the Imaging of Prostate Cancer
A Phase 2 study testing Computed Tomography, Gallium Ga 68 Gozetotide and Positron Emission Tomography in people with Biochemically Recurrent Prostate Carcinoma and Metastatic Castration-Resistant Prostate Carcinoma, run by University of Washington at 1 site in United States.
Trial summary
This trial studies how well 68Ga-PSMA-11 PET scan works in imaging patients with prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET may find and diagnose prostate cancer and improve monitoring of treatment response. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Biochemically Recurrent Prostate Carcinoma, Metastatic Castration-Resistant Prostate Carcinoma, Prostate Adenocarcinoma
- What is being tested?
- Computed Tomography, Gallium Ga 68 Gozetotide and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2021to 15 Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven prostate adenocarcinoma
- For the initial staging arm (initial staging cohort), high risk characteristics, including any of the following:
- Grade group 4-5 and/or
- PSA > 20 ng/mL
- For patients with biochemical recurrence (biochemical recurrence cohort):
- Rising PSA after definitive therapy with prostatectomy or targeted local therapy (including but not limited to external beam radiation therapy, brachytherapy, high-frequency ultrasound, and cryotherapy)
Show all 16Show fewer
- If post-radical prostatectomy, PSA > 0.2 ng/mL measured > 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (American Urological Association (AUA) definition for biochemical recurrence
- If post-radiation therapy, PSA that is equal to, or greater than, a 2 mg/mL rise above PSA nadir (American Society of Radiation Oncology (ASTRO) definition for biochemical recurrence)
- For patients undergoing systemic therapy (treatment monitoring cohort):
- Diagnosis of metastatic castration-resistant prostate cancer
- At least one or more measurable ( > 1 cm diameter in short axis) or evaluable lesions by any modality obtained within the past 60 days
- Planned for treatment with standard of care androgen receptor pathway inhibitor or chemotherapy
- This can include patients who have already undergone a standard of care Ga-68 PSMA PET/CT or PET/MR for determining eligibility for Lu-177 PSMA therapy, for whom the PET/CT or PET/MR did not confirm eligibility for treatment with Lu-177 PSMA, and who are planned to start treatment on chemotherapy or androgen receptor signaling inhibitor (ARSI) within 30 days of the Ga-68 PSMA PET. This can also include patients who have obtained a standard of care Ga-68 PSMA PET/CT or PET/MR for rising PSA to help with restaging prior to starting new treatment with ARSI or chemotherapy, even if Lu-177 PSMA is not being considered at that time. Scan 1 must be completed within 30 days of enrollment. Any patient with an equivocal lesion by conventional imaging, regardless of where they are in the course of evaluation or treatment (equivocal lesion cohort)
- No other malignancy within the past 2 years (with the exception of skin basal cell or cutaneous superficial squamous cell carcinoma, superficial bladder cancer, carcinoma in situ in any location, or Rai Stage 0 chronic lymphocytic leukemia, which are allowed)
- Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) performance status grades 0, 1, or 2
- Ability to understand and willingness to provide informed consent
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: 68Ga-PSMA-11 PET in Patients With Prostate Cancer
This trial studies how well 68Ga-PSMA-11 PET scan works in imaging patients with prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET may find and diagnose prostate cancer and improve monitoring of treatment response.
Read the detailed description
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 60-75 minutes then undergo PET/CT or PET/magnetic resonance (MR) scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
After the completion of study, patients are followed up at 60 days, 6 months, and annually up to 5 years or until time of first progression.
- Conditions
- Biochemically Recurrent Prostate Carcinoma, Metastatic Castration-Resistant Prostate Carcinoma, Prostate Adenocarcinoma, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
- Being tested
- Computed Tomography, Gallium Ga 68 Gozetotide, Positron Emission Tomography, Magnetic Resonance Imaging, Bone Scan
- Keywords
- Prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo PET/CT scan
Gallium Ga 68 GozetotideDrug
Also called (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/CT scan
Magnetic Resonance ImagingProcedure or surgery
Also called MRI, MR Imaging, NMRI, nuclear magnetic resonance imaging
Undergo PET/MR scan
Bone ScanProcedure or surgery
Undergo bone scan
Electronic Health Record ReviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR) | Experimental | Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study. Receives: Procedure: Computed Tomography; Drug: Gallium Ga 68 Gozetotide; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Bone Scan; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in planned management strategy
Assessed using conventional imaging with executed management strategy incorporating information from first (scan 1) 68Ga-prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT), regardless of treatment modality. Will be expressed as the percentage of total patients imaged in which change in management occurred, regardless of treatment modality. The rate of change in management will also be estimated within each group (initial staging, biochemical recurrence, and equivocal lesion cohorts). 95% confidence intervals (CIs) will be used to express precision of the estimates.
Measured: Baseline up to 1.5 years after the last scan
Secondary outcomes (9)
Major change in management
Defined as a change in treatment modality (e.g. change from systemic therapy to radiation therapy). Will compare by planned management strategy using conventional imaging and executed management strategy incorporating information from scan 1 68Ga-PSMA-11 PET/CT, regardless of treatment modality. 95% CIs will be used to express precision of the estimates. This analysis applies to the subjects enrolled in the initial staging (N=30), biochemical recurrence (N=30), and equivocal lesions cohorts (N=43).
Measured: Baseline up to 5 years post-scan
Minor change in management
Defined as changes within a treatment modality (e.g. change in planned radiation field or change in systemic therapy regimen to be used for a patient already planned to receive systemic therapy). Defined as a post-scan change within a treatment modality (e.g. alteration to salvage radiation field). 95% CIs will be used to express precision of the estimates.
Measured: Baseline up to 5 years post-scan
68Ga-PSMA-11 standardized uptake value maximum (SUVmax)
Changes in uptake will be compared among all groups using analysis of variance (ANOVA) or the Kruskal-Wallis test and between pairs of groups using the t-test or Wilcoxon rank-sum test.
Measured: Up to 6 weeks after systemic therapy initiation
68Ga-PSMA-11 standard uptake value normalized to lean body mass (SULpeak)
Changes in uptake will be compared among all groups using ANOVA or the Kruskal-Wallis test and between pairs of groups using the t-test or Wilcoxon rank-sum test.
Measured: Up to 6 weeks after systemic therapy initiation
Change in 68Ga-PSMA-11 SUVmax
Expressed as percent (%) change from scan 1. Will be determined and correlated with change in prostate specific antigen (PSA) level and Response Evaluation Criteria in Solid Tumors (RECIST) for measurable lesions, as assessed using Pearson's or Spearman's correlation coefficient. The relationship of changes in SUVmax and SULpeak with clinical response categories will also be assessed graphically and summarized overall with Spearman's rank correlation coefficient. Clinical response categories will be defined as complete response, partial response, stable disease, and progressive disease and determined by clinical assessment, conventional imaging, and biopsy (if available). The subgroup analysis of this group will be exploratory. Changes in uptake will be compared among all groups using ANOVA or the Kruskal-Wallis test and between pairs of groups using the t-test or Wilcoxon rank-sum test.
Measured: Baseline up to 6 weeks after systemic therapy initiation
Change in 68Ga-PSMA-11 SULpeak
Expressed as percent (%) change from scan 1. Will be determined and correlated with change in prostate specific antigen (PSA) level and Response Evaluation Criteria in Solid Tumors (RECIST) for measurable lesions, as assessed using Pearson's or Spearman's correlation coefficient. The relationship of changes in SUVmax and SULpeak with clinical response categories will also be assessed graphically and summarized overall with Spearman's rank correlation coefficient. Clinical response categories will be defined as complete response, partial response, stable disease, and progressive disease and determined by clinical assessment, conventional imaging, and biopsy (if available). The subgroup analysis of this group will be exploratory. Changes in uptake will be compared among all groups using ANOVA or the Kruskal-Wallis test and between pairs of groups using the t-test or Wilcoxon rank-sum test.
Measured: Baseline up to 6 weeks after systemic therapy initiation
Change in size of measurable metastatic lesions
Assessed by CT or magnetic resonance imaging (MRI) by RECIST 1.1 criteria.
Measured: Baseline up to 5 years post-scan
Histopathologic demonstration of prostate cancer within biopsy or surgical resection specimens
Will be performed only in patients with biopsy or surgical resection specimens. Lesions on each scan will be categorized as positive or negative. Pathology results will also be scored as positive or negative based on the clinical interpretation. These results will then be used to calculate accuracy with 95% CIs. CIs will be calculated using the non-parametric bootstrap with resampling by patient to account to dependence between lesions from the same patient.
Measured: Up to 5 years post-scan
Change in PSMA total tumor volume
Response defined by RECIST 1.1 criteria.
Measured: Baseline up to 5 years post-scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start17 May 2021
- Primary completion15 Jul 2025
- Study completion15 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biochemically Recurrent Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine L. Chen, M.D., Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777071
- Sponsor's protocol ID
- RG1007462
- Other IDs
- NCI-2020-02612, 10512
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2021
- Last updated
- 9 Jan 2026
- Results posted
- No
- 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-PSMA-11 PET in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT04777071
- Acronym / sponsor ID
- RG1007462
- Conditions
- Biochemically Recurrent Prostate Carcinoma, Metastatic Castration-Resistant Prostate Carcinoma, Prostate Adenocarcinoma, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
- Keywords
- Prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2030 (estimated)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies how well 68Ga-PSMA-11 PET scan works in imaging patients with prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET may find and diagnose prostate cancer and improve monitoring of treatment response.
Detailed description
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 60-75 minutes then undergo PET/CT or PET/magnetic resonance (MR) scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
After the completion of study, patients are followed up at 60 days, 6 months, and annually up to 5 years or until time of first progression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR) | Experimental | Procedure: Computed Tomography, Drug: Gallium Ga 68 Gozetotide, Procedure: Positron Emission Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Bone Scan, Other: Electronic Health Record ReviewPatients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study. |
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)
- Pathologically proven prostate adenocarcinoma
- For the initial staging arm (initial staging cohort), high risk characteristics, including any of the following:
- For patients with biochemical recurrence (biochemical recurrence cohort):
- For patients undergoing systemic therapy (treatment monitoring cohort):
- This can include patients who have already undergone a standard of care Ga-68 PSMA PET/CT or PET/MR for determining eligibility for Lu-177 PSMA therapy, for whom the PET/CT or PET/MR did not confirm eligibility for treatment with Lu-177 PSMA, and who are planned to start treatment on chemotherapy or androgen receptor signaling inhibitor (ARSI) within 30 days of the Ga-68 PSMA PET. This can also include patients who have obtained a standard of care Ga-68 PSMA PET/CT or PET/MR for rising PSA to help with restaging prior to starting new treatment with ARSI or chemotherapy, even if Lu-177 PSMA is not being considered at that time. Scan 1 must be completed within 30 days of enrollment. Any patient with an equivocal lesion by conventional imaging, regardless of where they are in the course of evaluation or treatment (equivocal lesion cohort)
Key exclusion criteria (1 listed)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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 |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo PET/CT scan | Procedure or surgery | Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR) |
| Gallium Ga 68 GozetotideAlso: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CCGiven IV | Drug | Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/CT scan | Procedure or surgery | Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR) |
| Magnetic Resonance ImagingAlso: MRI, MR Imaging, NMRI, nuclear magnetic resonance imagingUndergo PET/MR scan | Procedure or surgery | Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR) |
| Bone ScanUndergo bone scan | Procedure or surgery | Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR) |
| Electronic Health Record ReviewAncillary studies | Other | Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR) |
Primary outcome
Change in planned management strategy
Time frame: Baseline up to 1.5 years after the last scan
Assessed using conventional imaging with executed management strategy incorporating information from first (scan 1) 68Ga-prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT), regardless of treatment modality. Will be expressed as the percentage of total patients imaged in which change in management occurred, regardless of treatment modality. The rate of change in management will also be estimated within each group (initial staging, biochemical recurrence, and equivocal lesion cohorts). 95% confidence intervals (CIs) will be used to express precision of the estimates.
9 secondary outcomes
Major change in management
Time frame: Baseline up to 5 years post-scan
Minor change in management
Time frame: Baseline up to 5 years post-scan
68Ga-PSMA-11 standardized uptake value maximum (SUVmax)
Time frame: Up to 6 weeks after systemic therapy initiation
68Ga-PSMA-11 standard uptake value normalized to lean body mass (SULpeak)
Time frame: Up to 6 weeks after systemic therapy initiation
Change in 68Ga-PSMA-11 SUVmax
Time frame: Baseline up to 6 weeks after systemic therapy initiation
Change in 68Ga-PSMA-11 SULpeak
Time frame: Baseline up to 6 weeks after systemic therapy initiation
Change in size of measurable metastatic lesions
Time frame: Baseline up to 5 years post-scan
Histopathologic demonstration of prostate cancer within biopsy or surgical resection specimens
Time frame: Up to 5 years post-scan
Change in PSMA total tumor volume
Time frame: Baseline up to 5 years post-scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- 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.
Delphine L. Chen, M.D. principal investigator
Fred Hutch/University of Washington Cancer Consortium
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 Computed Tomography, Gallium Ga 68 Gozetotide and Positron Emission Tomography in people with Biochemically Recurrent Prostate Carcinoma and Metastatic Castration-Resistant Prostate Carcinoma, run by University of Washington 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 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: under way, not looking for participants, as of the sponsor's last update on 9 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in planned management strategy (time frame: Baseline up to 1.5 years after the last scan). 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 9 Jan 2026.