Prostate CancerEarly Phase 1NCT03768349
PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer
A Early Phase 1 study testing Ga-68 PSMA11 and F-18 PSMA 1007 in people with Prostate Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
Imaging and staging of prostate cancer is critical for surgical and treatment planning. In this protocol we will image patients with suspected metastatic prostate cancer using 11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 labeled PSMA 1007 in order to demonstrate their… 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 PSMA11 and F-18 PSMA 1007
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 21 Jul 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathological proven prostate adenocarcinoma.
- Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- Post radical prostatectomy (RP) - with or without radiation. i. PSA greater than or equal to 0.2 ng/mL measured more than 12 weeks after RP. ii. > 3 months post-surgery b. Post-radiation therapy ASTRO-Phoenix consensus definition c. May or may not be castrate resistant (list prior therapies)
- Karnofsky performance status of 50 (or ECOG/WHO equivalent).
- CT or as part of the PET study or performed within one month of PSMA PET.
- Age > 18.
- Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- Undergoing investigational therapy for prostate cancer.
- Other ongoing treatments for prostate cancer including radiation therapy, chemotherapy or androgen deprivation. Androgen deprivation within the last 4 months excluding finasteride, dutasteride or other 5 alpha reductase inhibitors (excluding castrate resistant subjects).
- Unable to lie flat, still or tolerate a PET scan.
- Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
- Absence of PSA and total testosterone tests within 4 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Imaging and staging of prostate cancer is critical for surgical and treatment planning. In this protocol we will image patients with suspected metastatic prostate cancer using 11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Ga-68 PSMA11, F-18 PSMA 1007
- Keywords
- Prostate Cancer, PET/CT, PSMA, C-11 Choline
- 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 PSMA11Drug
Ga-68 PSMA11 PET/CT for detection of tumor location
F-18 PSMA 1007Drug
F-18 PSMA 1007 PET/CT for detection of tumor location
| Study group | Role | What they receive |
|---|---|---|
| PET/CT Ga-68 PSMA | Experimental | Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT Receives: Drug: Ga-68 PSMA11 |
| PET/CT F-18 Labeled PSMA 1007 | Experimental | F-18 Labeled PSMA 1007 PET/CT Receives: Drug: F-18 PSMA 1007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Detection on PET/CT
Positive predictive value on a per-patient and per-region-basis of PSMA and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up.
Measured: 12 Months post PET/CT
Secondary outcomes (2)
Impact of PSMA and C-11 choline PET on clinical management
Descriptive statistics will be used to evaluate the impact of PSMA and C-11 choline PET on clinical management
Measured: 12 Months
Incidence of adverse events attributable to PSMA
Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start3 Jan 2019
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Val Lowe, Mayo Clinic
- Investigators
- Val Lowe, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768349
- Sponsor's protocol ID
- 18-006159
- Other IDs
- NCI-2019-07001, 18-006159, MC1952
- Status last verified
- Apr 2025
- First submitted
- 4 Dec 2018
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD data from this trial will be available to other researchers that will collate similar data from multiple sites to provide data to the FDA.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer
- ClinicalTrials.gov ID
- NCT03768349
- Acronym / sponsor ID
- 18-006159
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, PET/CT, PSMA, C-11 Choline
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 7 Dec 2018 (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.
Imaging and staging of prostate cancer is critical for surgical and treatment planning. In this protocol we will image patients with suspected metastatic prostate cancer using 11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PET/CT Ga-68 PSMA | Experimental | Drug: Ga-68 PSMA11Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT |
| PET/CT F-18 Labeled PSMA 1007 | Experimental | Drug: F-18 PSMA 1007F-18 Labeled PSMA 1007 PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histopathological proven prostate adenocarcinoma.
- Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- Karnofsky performance status of 50 (or ECOG/WHO equivalent).
- CT or as part of the PET study or performed within one month of PSMA PET.
- Age > 18.
Key exclusion criteria (6 listed)
- Undergoing investigational therapy for prostate cancer.
- Other ongoing treatments for prostate cancer including radiation therapy, chemotherapy or androgen deprivation. Androgen deprivation within the last 4 months excluding finasteride, dutasteride or other 5 alpha reductase inhibitors (excluding castrate resistant subjects).
- Unable to lie flat, still or tolerate a PET scan.
- Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ga-68 PSMA11Ga-68 PSMA11 PET/CT for detection of tumor location | Drug | PET/CT Ga-68 PSMA |
| F-18 PSMA 1007F-18 PSMA 1007 PET/CT for detection of tumor location | Drug | PET/CT F-18 Labeled PSMA 1007 |
Primary outcome
Tumor Detection on PET/CT
Time frame: 12 Months post PET/CT
Positive predictive value on a per-patient and per-region-basis of PSMA and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up.
2 secondary outcomes
Impact of PSMA and C-11 choline PET on clinical management
Time frame: 12 Months
Incidence of adverse events attributable to PSMA
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The IPD data from this trial will be available to other researchers that will collate similar data from multiple sites to provide data to the FDA.
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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.
Val Lowe, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ga-68 PSMA11 and F-18 PSMA 1007 in people with Prostate Cancer, run by Mayo Clinic 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 7 inclusion and 6 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 6 Apr 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tumor Detection on PET/CT (time frame: 12 Months post PET/CT). 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 6 Apr 2025.