Prostate CancerPhase 3NCT05799248
Role of rhPSMA-7.3 PET/CT Imaging in Men With High-Risk Prostate Cancer Following Conventional Imaging and Associated Changes in Medical Management
A Phase 3 study testing rhPSMA-7.3 (18F) in people with Prostate Cancer, run by MidLantic Urology at 1 site in United States.
Trial summary
Study Title: Role of rhPSMA-7.3 PET/CT imaging in men with High-Risk prostate cancer following conventional imaging and associated changes in medical management Protocol number: BED-IIT-437 Phase: 3b Sponsor: MidLantic Urology Funding Organization: Blue Earth Diagnostics Ltd Study Design: This is a Phase 3b… 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?
- rhPSMA-7.3 (18F)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2023to 28 May 2024
- Phase
- Phase 3
- 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
- Patient willing to provide signed informed consent and willing to comply with all required study schedule events, where safe and feasible.
- Patient is male and aged >18 years old.
- Histologically confirmed adenocarcinoma of the prostate.
- High risk prostate cancer. High-risk patients will be defined as having any of the following criteria: primary Gleason grade 4, or any Gleason grade 5, PSA ≥20, or clinical stage T3a (per NCCN Guidelines Version 2.2019; PROS-2).
Who cannot join
- Patients with any medical condition or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
- Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
- Patients currently receiving, or with a prior history of, androgen deprivation therapy (ADT; defined as surgical orchidectomy; luteinizing hormone-releasing hormone [LHRH] agonist alone [continuous or intermittent]; LHRH antagonist alone [continuous or intermittent]; administration or use of a first generation or second generation anti-androgen alone or in combination with an LHRH agonist/antagonist).
- Patients participating in an interventional clinical trial within 30 days and having received an IP within five biological half-lives prior to administration of rhPSMA-7.3.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Cheryl Zinar, RN, BSN, 610-667-0458, czinar@midlanticurology.com
Laurence Belkoff, DO
About this study
Study Title: Role of rhPSMA-7.3 PET/CT imaging in men with High-Risk prostate cancer following conventional imaging and associated changes in medical management Protocol number: BED-IIT-437 Phase: 3b Sponsor: MidLantic Urology Funding Organization: Blue Earth Diagnostics Ltd Study Design: This is a Phase 3b, multi-center, single-arm, diagnostic imaging study designed to detect metastatic lesions in men diagnosed with high-risk prostate cancer.
Read the detailed description
Consented patients will be screened to determine eligibility for the study prior to investigational product (IP) administration. In addition to their routine clinical work-up, which will include 99mtechnetium-biphosphonate bone scan and abdominal/pelvic computed tomography (CT) or magnetic resonance imaging (MRI) and chest CT per local practice, and before the scheduled radical prostatectomy (RP) and pelvic lymph node dissection (PLND), or radical pelvic radiation therapy, patients will receive 8 mCi (296 MBq) ± 20% rhPSMA-7.3, delivered as an intravenous (IV) bolus injection, followed by PET imaging. For each patient, the PET imaging results will be reported to the responsible physician prior to the planned treatment. Imaging results and further procedures/treatment plan should be discussed with the patient within 7 days after rhPSMA-7.3 imaging (this may be conducted by telephone at the clinician's discretion). Within 45 days post-IP administration, the patient will receive treatment as follows:
- Standard of care surgical treatment of PCa, including PLND; or
- If the rhPSMA-7.3 PET scan detects M1 lesion(s):
- A biopsy/surgery and/or additional imaging to confirm M1 lesion(s) will be required prior to initiation of treatment.
The purpose of this study is to assess the accuracy of rhPSMA-7.3 PET/CT with conventional imaging for detecting metastatic disease in men with high-risk prostate cancer and the impact on medical management of these men. Accurate staging of newly diagnosed PCa assists in directing appropriate treatment strategies. In patients with high-risk PCa, the primary goal of imaging is to detect extra-prostatic disease. The identification of metastatic disease may significantly change the planned treatment regimen from locoregional to systemic therapy
- Conditions
- Prostate Cancer
- Being tested
- rhPSMA-7.3 (18F)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhPSMA-7.3 (18F)Drug
Also called radiohybrid PSMA-targeted PET imaging agent, Radioligand for PET CT scanning
Patients will receive a dose with an administered activity of 8 mCi (296 MBq) ± 20% of rhPSMA-7.3, delivered as an IV bolus injection with a 10 mL fast 0.9% sodium chloride flush, followed by PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| rhPSMA-7.3 | Experimental | Role of rhPSMA-7.3 PET/CT imaging in men with High-Risk prostate cancer following conventional imaging and associated changes in medical management Receives: Drug: rhPSMA-7.3 (18F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate cancer upstaging
Compare the accuracy of rhPSMA-7.3 PET/CT with conventional imaging for detecting metastatic disease and up-staging of disease in men with high-risk prostate cancer
Measured: 15 months
Secondary outcomes (5)
Verified Detection Rate of rhPSMA-7.3
To assess the Verified Detection Rate (VDR) for M1 disease of rhPSMA-7.3 PET/CT findings (as determined by central BIE) on a patient level in with high-risk prostate cancer
Measured: 15 months
Positive predictive value of rhPSMA-7.3
To assess the VDR and determine PPV for M1 disease of rhPSMA-7.3 PET/CT findings (as determined by central BIE) on a patient level in patients with negative conventional imaging
Measured: 15 months
Metastasis detection rate
Percentage of patients in which rhPSMA-7.3 PET/CT imaging detects at least one verified M1 metastasis, as determined by central BIE
Measured: 15 months
Metastasis detection rate with negative imaging
Percentage of patients with negative conventional imaging for M1 disease in whom rhPSMA-7.3 PET/CT detects at least one verified M1 metastasis, as determined by central BIE
Measured: 15 months
Positive predictive value of rhPSMA compared to biopsy
The PPV of rhPSMA-7.3 PET/CT to detect distant disease compared to biopsy in those patients who undergo a distant disease biopsy on the basis of a rhPSMA-7.3 PET/CT finding or in case of bony disease a correlation with MRI or biopsy
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start27 Apr 2023
- Primary completion28 May 2024 (estimated)
- Study completion28 May 2024 (estimated)
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
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- role of rhPSMA-7.3 in PET/CT
- Masking
- None (open label)
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MidLantic Urology
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor
- Investigators
- Laurence Belkoff, DO, FACOS, Principal investigator, MidLantic Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799248
- Sponsor's protocol ID
- BED-IIT-437
- Status last verified
- May 2024
- First submitted
- 21 Feb 2023
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of rhPSMA-7.3 PET/CT Imaging in Men With High-Risk Prostate Cancer Following Conventional Imaging and Associated Changes in Medical Management
- ClinicalTrials.gov ID
- NCT05799248
- Acronym / sponsor ID
- BED-IIT-437
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- MidLantic UrologyUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 28 May 2024 (estimated)
- Study completion
- 28 May 2024 (estimated)
- First posted
- 5 Apr 2023 (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.
Study Title: Role of rhPSMA-7.3 PET/CT imaging in men with High-Risk prostate cancer following conventional imaging and associated changes in medical management Protocol number: BED-IIT-437 Phase: 3b Sponsor: MidLantic Urology Funding Organization: Blue Earth Diagnostics Ltd Study Design: This is a Phase 3b, multi-center, single-arm, diagnostic imaging study designed to detect metastatic lesions in men diagnosed with high-risk prostate cancer.
Detailed description
Consented patients will be screened to determine eligibility for the study prior to investigational product (IP) administration. In addition to their routine clinical work-up, which will include 99mtechnetium-biphosphonate bone scan and abdominal/pelvic computed tomography (CT) or magnetic resonance imaging (MRI) and chest CT per local practice, and before the scheduled radical prostatectomy (RP) and pelvic lymph node dissection (PLND), or radical pelvic radiation therapy, patients will receive 8 mCi (296 MBq) ± 20% rhPSMA-7.3, delivered as an intravenous (IV) bolus injection, followed by PET imaging. For each patient, the PET imaging results will be reported to the responsible physician prior to the planned treatment. Imaging results and further procedures/treatment plan should be discussed with the patient within 7 days after rhPSMA-7.3 imaging (this may be conducted by telephone at the clinician's discretion). Within 45 days post-IP administration, the patient will receive treatment as follows:
- Standard of care surgical treatment of PCa, including PLND; or
- If the rhPSMA-7.3 PET scan detects M1 lesion(s):
- A biopsy/surgery and/or additional imaging to confirm M1 lesion(s) will be required prior to initiation of treatment.
The purpose of this study is to assess the accuracy of rhPSMA-7.3 PET/CT with conventional imaging for detecting metastatic disease in men with high-risk prostate cancer and the impact on medical management of these men. Accurate staging of newly diagnosed PCa assists in directing appropriate treatment strategies. In patients with high-risk PCa, the primary goal of imaging is to detect extra-prostatic disease. The identification of metastatic disease may significantly change the planned treatment regimen from locoregional to systemic therapy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- role of rhPSMA-7.3 in PET/CT
| Arm | Type | Receives |
|---|---|---|
| rhPSMA-7.3 | Experimental | Drug: rhPSMA-7.3 (18F)Role of rhPSMA-7.3 PET/CT imaging in men with High-Risk prostate cancer following conventional imaging and associated changes in medical management |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient willing to provide signed informed consent and willing to comply with all required study schedule events, where safe and feasible.
- Patient is male and aged >18 years old.
- Histologically confirmed adenocarcinoma of the prostate.
- High risk prostate cancer. High-risk patients will be defined as having any of the following criteria: primary Gleason grade 4, or any Gleason grade 5, PSA ≥20, or clinical stage T3a (per NCCN Guidelines Version 2.2019; PROS-2).
Key exclusion criteria (4 listed)
- Patients with any medical condition or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
- Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
- Patients currently receiving, or with a prior history of, androgen deprivation therapy (ADT; defined as surgical orchidectomy; luteinizing hormone-releasing hormone [LHRH] agonist alone [continuous or intermittent]; LHRH antagonist alone [continuous or intermittent]; administration or use of a first generation or second generation anti-androgen alone or in combination with an LHRH agonist/antagonist).
- Patients participating in an interventional clinical trial within 30 days and having received an IP within five biological half-lives prior to administration of rhPSMA-7.3.
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 |
|---|---|---|
| rhPSMA-7.3 (18F)Also: radiohybrid PSMA-targeted PET imaging agent, Radioligand for PET CT scanningPatients will receive a dose with an administered activity of 8 mCi (296 MBq) ± 20% of rhPSMA-7.3, delivered as an IV bolus injection with a 10 mL fast 0.9% sodium chloride flush, followed by PET imaging. | Drug | rhPSMA-7.3 |
Primary outcome
Prostate cancer upstaging
Time frame: 15 months
Compare the accuracy of rhPSMA-7.3 PET/CT with conventional imaging for detecting metastatic disease and up-staging of disease in men with high-risk prostate cancer
5 secondary outcomes
Verified Detection Rate of rhPSMA-7.3
Time frame: 15 months
Positive predictive value of rhPSMA-7.3
Time frame: 15 months
Metastasis detection rate
Time frame: 15 months
Metastasis detection rate with negative imaging
Time frame: 15 months
Positive predictive value of rhPSMA compared to biopsy
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
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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.
Laurence Belkoff, DO, FACOS principal investigator
MidLantic Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rhPSMA-7.3 (18F) in people with Prostate Cancer, run by MidLantic Urology 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheryl Zinar, RN,BSN (610-667-0458, czinar@midlanticurology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate cancer upstaging (time frame: 15 months). 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 24 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.