Prostate CancerPhase 3AMPLIFYNCT06970847
64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer
A Phase 3 study testing 64Cu-SAR-bisPSMA in people with Prostate Cancer and Prostate Cancer Patients With Detectable PSA Following Prostatectomy, run by Clarity Pharmaceuticals Ltd at 22 sites in 2 countries.
Trial summary
The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Patients With Detectable PSA Following Prostatectomy, Prostate Cancer Recurrent
- What is being tested?
- 64Cu-SAR-bisPSMA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 16 May 2025to 31 Dec 2026
- Phase
- Phase 3
- 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
- At least 18 years of age.
- Signed informed consent.
- Life expectancy ≥ 6 months as determined by the Investigator.
- Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
- Participant potentially eligible for salvage therapy with curative intent (i.e. aligns with the definition of loco-regional therapy as described in protocol Section 7.2).
- PSA level after definitive therapy:
Show all 10Show fewer
- Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per AUA recommendation) or
- Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per ASTRO-Phoenix consensus definition).
- Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of PC, where this is safe and feasible.
- An Eastern Cooperative Oncology performance status of 0-2.
Who cannot join
- Participants who received investigational agent within 5 biological half-lives prior to Day 1.
- Participants administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
- Participants with known predominant small cell or neuroendocrine PC.
- Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy and/or salvage therapy with radiation).
- Ongoing treatment or treatment within 6 months of Day 1 with any systemic therapy (e.g. any investigational therapy, androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist, chemotherapy, immunotherapy or radiotherapy) for PC.
- Participants for whom there is an intent to initiate a prohibited medication(s)/treatment(s) (refer to Section 7.3) during the course of the participant's involvement in the study.
- Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
- Any serious medical condition or extenuating circumstance (including receiving the investigational product or not capable of having a PET scan) which the investigator feels may interfere with the procedures or evaluations of the study.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States18 sites
Albany Medical College
Albany, New York, 12208
Urology Clinics of North Texas
Dallas, Texas, 75231
Endeavor Health- Glenbrook Hospital
Glenview, Illinois, 60201
Indiana University Health-IU Simon Cancer Center
Indianapolis, Indiana, 46202
UC Irvine
Irvine, California, 92697
Comprehensive Urology Medical Group
Los Angeles, California, 90048
XCancer Research Network / LCMC Health EJGH
Metairie, Louisiana, 700006
Biogenix Molecular
Miami, Florida, 33165
M. Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Alarcon Urology Center
Montebello, California, 90640
Summit Urology
Murray, Utah, 84107
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Urology Associates, P.C.
Nashville, Tennessee, 37209
XCancer
Omaha, Nebraska, 68130
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15260
Intermountain Medical Center
Salt Lake City, Utah, 84111
The Urology Place
San Antonio, Texas, 78240
St. Louis University
St Louis, Missouri, 63103
Australia4 sites
St. Vincent's Hospital, Sydney
Darlinghurst, New South Wales, 2010
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076
Westmead Private Hosptial
Westmead, New South Wales, 2145
About this study
The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
- Conditions
- Prostate Cancer, Prostate Cancer Patients With Detectable PSA Following Prostatectomy, Prostate Cancer Recurrent, Prostate Cancer Patients Who Have Brachytherapy Seed Implant, Prostate Cancer Patients Treated by Radiotherapy, Cryotherapy
- Being tested
- 64Cu-SAR-bisPSMA
- Keywords
- Prostate Cancer, Prostate, Biochemical Recurrence
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-SAR-bisPSMADrug
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA
| Study group | Role | What they receive |
|---|---|---|
| 64Cu-SAR-bisPSMA 200MBq 64Cu-SAR-bisPSMA. | Experimental | Not described Receives: Drug: 64Cu-SAR-bisPSMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
Co-primary endpoints of participant-level CDR and region level PPV assessed independently for Day 1 and Day 2:
- Participant-level CDR, defined as the proportion of TP participants scan out of all participants
- Region-level PPV, defined as the proportion of TP regions out of all positive regions.
Measured: Up to 52 Weeks
Secondary outcomes (9)
To investigate the safety and tolerability of 64-CuSAR-bisPSMA
Incidence and severity of TEAEs and SAEs following the administration of 64CuSARbisPSMA
Measured: Up to 52 Weeks
To assess the participants-level PPV of 64Cu-SAR-bisPSMA PET/CT
Participant-level PPV, defined as the proportion of participants with a TP scan out of all participants with a true or false positive scan.
Measured: Up to 52 Weeks
To assess the participant-level DR of 64Cu-SAR-bisPSMA PET/CT
Participant-level DR, defined as the proportion of participants with a positive scan out of all participants.
Measured: Up to 52 Weeks
To determine the efficacy of 64Cu-SAR-bisPSMA PET/CT in participants with negative or equivocal conventional imaging at baseline
Detection Rate in participants with a negative or equivocal conventional imaging at baseline.
Measured: Up to 52 Weeks
To determine the effect of the composition of Reference Standard on the performance of 64Cu-SAR-bisPSMA PET/CT
Positive Predictive Value (participant- and region-level) assessed in subgroups based on the type of evidence and with/without histopathology.
Measured: Up to 52 Weeks
To evaluate the consistency among readers and the reproducibility of the 64Cu-SAR-bisPSMA PET/CT readings
Inter-reader variability expressed with kappa statistics for the 64Cu-SAR-bisPSMA PET/CT interpretation by the three central readers.
Measured: Up to 52 Weeks
To evaluate the consistency among readers and the reproducibility of the 64Cu-SAR-bisPSMA PET/CT readings
Intra-reader variability expressed with kappa statistics for the 64Cu-SAR-bisPSMA PET/CT interpretation by the three central readers.
Measured: Up to 52 Weeks
To determine the efficacy of 64Cu-SAR-bisPSMA PET/CT in participants with negative or equivocal conventional imaging at baseline
Positive Predictive Values (participant and region level) in participants with a negative or equivocal conventional imaging at baseline.
Measured: Up to 52 Weeks
To determine the effect of the composition of Reference Standard on the performance of 64Cu-SAR-bisPSMA PET/CT
Correct Detection Rate assessed in subgroups based on the type of evidence and with/without histopathology.
Measured: Up to 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start16 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clarity Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970847
- Sponsor's protocol ID
- CLP10
- Acronym
- AMPLIFY
- Status last verified
- May 2026
- First submitted
- 29 Apr 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Concerns related to confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer
- ClinicalTrials.gov ID
- NCT06970847
- Acronym / sponsor ID
- AMPLIFY / CLP10
- Conditions
- Prostate Cancer, Prostate Cancer Patients With Detectable PSA Following Prostatectomy, Prostate Cancer Recurrent, Prostate Cancer Patients Who Have Brachytherapy Seed Implant, Prostate Cancer Patients Treated by Radiotherapy, Cryotherapy
- Keywords
- Prostate Cancer, Prostate, Biochemical Recurrence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Clarity Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- 16 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 May 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.
The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 64Cu-SAR-bisPSMA 200MBq 64Cu-SAR-bisPSMA. | Experimental | Drug: 64Cu-SAR-bisPSMA |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 18 years of age.
- Signed informed consent.
- Life expectancy ≥ 6 months as determined by the Investigator.
- Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
- Participant potentially eligible for salvage therapy with curative intent (i.e. aligns with the definition of loco-regional therapy as described in protocol Section 7.2).
Key exclusion criteria (8 listed)
- Participants who received investigational agent within 5 biological half-lives prior to Day 1.
- Participants administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
- Participants with known predominant small cell or neuroendocrine PC.
- Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy and/or salvage therapy with radiation).
- Ongoing treatment or treatment within 6 months of Day 1 with any systemic therapy (e.g. any investigational therapy, androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist, chemotherapy, immunotherapy or radiotherapy) for PC.
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 |
|---|---|---|
| 64Cu-SAR-bisPSMAAll Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA | Drug | 64Cu-SAR-bisPSMA 200MBq 64Cu-SAR-bisPSMA. |
Primary outcome
Ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
Time frame: Up to 52 Weeks
Co-primary endpoints of participant-level CDR and region level PPV assessed independently for Day 1 and Day 2: * Participant-level CDR, defined as the proportion of TP participants scan out of all participants * Region-level PPV, defined as the proportion of TP regions out of all positive regions.
9 secondary outcomes
To investigate the safety and tolerability of 64-CuSAR-bisPSMA
Time frame: Up to 52 Weeks
To assess the participants-level PPV of 64Cu-SAR-bisPSMA PET/CT
Time frame: Up to 52 Weeks
To assess the participant-level DR of 64Cu-SAR-bisPSMA PET/CT
Time frame: Up to 52 Weeks
To determine the efficacy of 64Cu-SAR-bisPSMA PET/CT in participants with negative or equivocal conventional imaging at baseline
Time frame: Up to 52 Weeks
To determine the effect of the composition of Reference Standard on the performance of 64Cu-SAR-bisPSMA PET/CT
Time frame: Up to 52 Weeks
To evaluate the consistency among readers and the reproducibility of the 64Cu-SAR-bisPSMA PET/CT readings
Time frame: Up to 52 Weeks
To evaluate the consistency among readers and the reproducibility of the 64Cu-SAR-bisPSMA PET/CT readings
Time frame: Up to 52 Weeks
To determine the efficacy of 64Cu-SAR-bisPSMA PET/CT in participants with negative or equivocal conventional imaging at baseline
Time frame: Up to 52 Weeks
To determine the effect of the composition of Reference Standard on the performance of 64Cu-SAR-bisPSMA PET/CT
Time frame: Up to 52 Weeks
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 14 May 2026.
- Individual participant dataSharing planned: No. Concerns related to confidentiality.
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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.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 64Cu-SAR-bisPSMA in people with Prostate Cancer and Prostate Cancer Patients With Detectable PSA Following Prostatectomy, run by Clarity Pharmaceuticals Ltd at 22 sites in 2 countries.
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 10 inclusion and 8 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 14 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 22 sites in United States, Australia. 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?
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?
Ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer (time frame: Up to 52 Weeks). 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 14 May 2026.