Prostate CancerEarly Phase 1PIONEER PSMANCT07069465
Pilot Study: Androgen Deprivation Therapy Impact on PSMA-PET Sensitivity in Prostatectomy Staging
A Early Phase 1 study testing flotufolastat F 18, Relugolix 120 MG and Serum PSA and Testosterone in people with Prostate Cancer, run by Urology Clinics of North Texas at 1 site in United States.
Trial summary
This is a pilot, non-randomized, two-cohort interventional study in patients who meet the inclusion criteria, using an FDA- approved androgen deprivation agent for a 3 or 6-week course of treatment prior to standard-of-care RALP with PLND. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- flotufolastat F 18, Relugolix 120 MG and Serum PSA and Testosterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2024to 6 Nov 2024
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men diagnosed with unfavorable intermediate or high-risk prostate cancer where RALP and PLND is planned and consulted with primary urologist
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Determine the Effect of Androgen Deprivation Therapy on the Sensitivity of PSMA-PET Scanning for Patients Undergoing Initial Staging Prior to Robot-Assisted Laparoscopic Radical Prostatectomy and Pelvic Lymphadenectomy
This is a pilot, non-randomized, two-cohort interventional study in patients who meet the inclusion criteria, using an FDA- approved androgen deprivation agent for a 3 or 6-week course of treatment prior to standard-of-care RALP with PLND. The intent of the study is to determine the effect of ADT on PSMA expression as measured by PSMA-PET scan. A second PSMA-PET scan will be performed after ADT for either 3 or 6 weeks, depending on cohort, prior to RALP and PLND.
- Conditions
- Prostate Cancer
- Being tested
- flotufolastat F 18, Relugolix 120 MG, Serum PSA and Testosterone
- Keywords
- Prostate, Prostate Cancer, Androgen Deprivation Therapy, Posluma, Orgovyx, PSMA-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.
flotufolastat F 18Diagnostic test
Also called Posluma
PSMA-PET scan with Posluma agent (x2)
Relugolix 120 MGDrug
Also called Orgovyx
Administration of oral ADT for 3 and 6 weeks
Serum PSA and TestosteroneDiagnostic test
Serum PSA and testosterone at study initiation and again at 3 and 6 weeks after initiation of ADT
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Active comparator | 5 patients (Cohort A) undergo a second study PSMA-PET with POSLUMA® 3 weeks after initiation of ADT and discontinue ADT immediately after the scan is completed. Receives: Diagnostic Test: flotufolastat F 18; Drug: Relugolix 120 MG; Diagnostic Test: Serum PSA and Testosterone |
| Cohort B | Active comparator | 5 patients (Cohort B) undergo a second study PSMA-PET with POSLUMA® 6 weeks after initiation of ADT and discontinue ADT immediately after the scan is completed. Receives: Diagnostic Test: flotufolastat F 18; Drug: Relugolix 120 MG; Diagnostic Test: Serum PSA and Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Mean change in maximum standardized uptake value (SUVmax) per lesion as measured by PSMA-PET (POSLUMA®) from baseline to post-ADT
Time Frame: Baseline and 3-6 weeks after initiation of ADT Description: SUVmax will be measured on PSMA-PET for each lesion identified prior to ADT and again after 3 or 6 weeks of ADT (depending on cohort). The primary metric will be the mean change in SUVmax per lesion, per participant. Data will be summarized as mean ± SD, and analyzed using paired statistical testing to determine significance of change.
Measured: 3-6 weeks
New lesions not identified pre-treatment are detectable after ADT
Time Frame: Baseline and 3-6 weeks post-ADT initiation Description: PSMA-PET scans performed at 3 or 6 weeks after ADT will be compared to baseline scans to identify newly visible lesions. The outcome will be reported as the number and proportion of participants with new lesions. Descriptive statistics will be used to summarize findings.
Measured: 3-6 weeks
Establish the optimal duration of ADT necessary to achieve castrate level of testosteroneTime to castration-level testosterone (≤50 ng/dL) following initiation of oral ADT (relugolix 120 mg daily)
Time Frame: 0 to 6 weeks after initiation of ADT Description: Serum testosterone will be measured at baseline, 3 weeks, and 6 weeks. The time point at which testosterone ≤50 ng/dL is first achieved will be recorded for each participant. Data will be summarized by frequency, proportion, and median time to castration levels.
Measured: 3-6 weeks
Proportion of lesions visible on baseline PSMA-PET that remain detectable on post-ADT PSMA-PET
Time Frame: Baseline and 3-6 weeks after initiation of ADT Description: Lesions identified at baseline will be matched to post-ADT PSMA-PET scans. The number and proportion of lesions that remain visible after ADT will be recorded. This will help assess whether ADT obscures PSMA-positive disease on imaging.
Measured: 3-6 weeks
Secondary outcomes (2)
Correlation between PSMA-PET findings and surgical pathology
Time Frame: Surgery performed 6-10 weeks after enrollment Description: Lesions identified by PSMA-PET will be compared to histopathologic findings from prostatectomy and pelvic lymph node dissection specimens. Correlation statistics (e.g., sensitivity, specificity, positive predictive value) will be calculated.
Measured: 3-6 weeks
Concordance between study PSMA-PET and conventional imaging or alternative PSMA-PET agents (if available)
Time Frame: 3-6 weeks after ADT, when comparator imaging is available Description: In participants who undergo additional imaging (e.g., bone scan, CT, or alternative PSMA-PET tracers), lesions will be compared to those seen on study PSMA-PET. Concordance will be reported as number and proportion of lesions detected by both modalities.
Measured: 3-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start15 Jun 2024
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
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.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urology Clinics of North Texas
- Sponsor type
- Research network
- Collaborators
- Blue Earth Diagnostics, Texas Health Resources
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069465
- Sponsor's protocol ID
- STU-2023-1275
- Acronym
- PIONEER PSMA
- Status last verified
- Jun 2025
- First submitted
- 29 May 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Determine the Effect of Androgen Deprivation Therapy on the Sensitivity of PSMA-PET Scanning for Patients Undergoing Initial Staging Prior to Robot-Assisted Laparoscopic Radical Prostatectomy and Pelvic Lymphadenectomy
- ClinicalTrials.gov ID
- NCT07069465
- Acronym / sponsor ID
- PIONEER PSMA / STU-2023-1275
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Prostate Cancer, Androgen Deprivation Therapy, Posluma, Orgovyx, PSMA-PET
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Urology Clinics of North TexasResearch network
- Collaborators
- Blue Earth Diagnostics, Texas Health Resources
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 16 Jul 2025 (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 is a pilot, non-randomized, two-cohort interventional study in patients who meet the inclusion criteria, using an FDA- approved androgen deprivation agent for a 3 or 6-week course of treatment prior to standard-of-care RALP with PLND. The intent of the study is to determine the effect of ADT on PSMA expression as measured by PSMA-PET scan. A second PSMA-PET scan will be performed after ADT for either 3 or 6 weeks, depending on cohort, prior to RALP and PLND.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Active comparator | Diagnostic Test: flotufolastat F 18, Drug: Relugolix 120 MG, Diagnostic Test: Serum PSA and Testosterone5 patients (Cohort A) undergo a second study PSMA-PET with POSLUMA® 3 weeks after initiation of ADT and discontinue ADT immediately after the scan is completed. |
| Cohort B | Active comparator | Diagnostic Test: flotufolastat F 18, Drug: Relugolix 120 MG, Diagnostic Test: Serum PSA and Testosterone5 patients (Cohort B) undergo a second study PSMA-PET with POSLUMA® 6 weeks after initiation of ADT and discontinue ADT immediately after the scan is completed. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Men diagnosed with unfavorable intermediate or high-risk prostate cancer where RALP and PLND is planned and consulted with primary urologist
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| flotufolastat F 18Also: PoslumaPSMA-PET scan with Posluma agent (x2) | Diagnostic test | Cohort A, Cohort B |
| Relugolix 120 MGAlso: OrgovyxAdministration of oral ADT for 3 and 6 weeks | Drug | Cohort A, Cohort B |
| Serum PSA and TestosteroneSerum PSA and testosterone at study initiation and again at 3 and 6 weeks after initiation of ADT | Diagnostic test | Cohort A, Cohort B |
Primary outcome
1. Mean change in maximum standardized uptake value (SUVmax) per lesion as measured by PSMA-PET (POSLUMA®) from baseline to post-ADT
Time frame: 3-6 weeks
Time Frame: Baseline and 3-6 weeks after initiation of ADT Description: SUVmax will be measured on PSMA-PET for each lesion identified prior to ADT and again after 3 or 6 weeks of ADT (depending on cohort). The primary metric will be the mean change in SUVmax per lesion, per participant. Data will be summarized as mean ± SD, and analyzed using paired statistical testing to determine significance of change.
New lesions not identified pre-treatment are detectable after ADT
Time frame: 3-6 weeks
Time Frame: Baseline and 3-6 weeks post-ADT initiation Description: PSMA-PET scans performed at 3 or 6 weeks after ADT will be compared to baseline scans to identify newly visible lesions. The outcome will be reported as the number and proportion of participants with new lesions. Descriptive statistics will be used to summarize findings.
Establish the optimal duration of ADT necessary to achieve castrate level of testosteroneTime to castration-level testosterone (≤50 ng/dL) following initiation of oral ADT (relugolix 120 mg daily)
Time frame: 3-6 weeks
Time Frame: 0 to 6 weeks after initiation of ADT Description: Serum testosterone will be measured at baseline, 3 weeks, and 6 weeks. The time point at which testosterone ≤50 ng/dL is first achieved will be recorded for each participant. Data will be summarized by frequency, proportion, and median time to castration levels.
Proportion of lesions visible on baseline PSMA-PET that remain detectable on post-ADT PSMA-PET
Time frame: 3-6 weeks
Time Frame: Baseline and 3-6 weeks after initiation of ADT Description: Lesions identified at baseline will be matched to post-ADT PSMA-PET scans. The number and proportion of lesions that remain visible after ADT will be recorded. This will help assess whether ADT obscures PSMA-positive disease on imaging.
2 secondary outcomes
Correlation between PSMA-PET findings and surgical pathology
Time frame: 3-6 weeks
Concordance between study PSMA-PET and conventional imaging or alternative PSMA-PET agents (if available)
Time frame: 3-6 weeks
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 16 Jul 2025.
- Related InfoLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 flotufolastat F 18, Relugolix 120 MG and Serum PSA and Testosterone in people with Prostate Cancer, run by Urology Clinics of North Texas 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 1 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 16 Jul 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?
1. Mean change in maximum standardized uptake value (SUVmax) per lesion as measured by PSMA-PET (POSLUMA®) from baseline to post-ADT (time frame: 3-6 weeks). 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?
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 16 Jul 2025.