Prostatic Neoplasms, Castration-ResistantPhase 1/2SECuRENCT04868604
64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)
A Phase 1/2 study testing 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA in people with Prostatic Neoplasms, Castration-Resistant, run by Clarity Pharmaceuticals Ltd at 7 sites in United States.
Trial summary
The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Castration-Resistant
- What is being tested?
- 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Aug 2021to Sep 2026
- Phase
- Phase 1/2
- 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
- Signed informed consent;
- ≥18 years of age;
- Eastern Cooperative Oncology Group performance status of 0 to 2;
- Life expectancy >6 months;
- Histological, pathological, and/or cytological confirmation of Prostate cancer (PCa);
- Positive 64Cu-SAR-bisPSMA PET/CT scan, where 64Cu-SAR-bisPSMA uptake (standardized uptake value [SUV] max) of at least 1 known lesion is higher than that of the liver on the 1 hour positron emission tomography (PET)/computed tomography (CT) scan;
Show all 28Show fewer
- Castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L);
- Have progressive metastatic castration-resistant prostate cancer (mCRPC) despite prior androgen deprivation therapy and:
- Dose Escalation: at least either enzalutamide and/or abiraterone (or other such androgen receptor pathway inhibitors [androgen receptor pathway inhibitorsARPIs]).
- Cohort Expansion Main Group: Participant has progressed once or twice on a prior second generation ARPI (abiraterone, enzalutamide, darolutamide, or apalutamide). No concomitant ARPI on study. Note: First generation ARPI is allowed but not considered as prior ARPI. Second generation ARPI must be the most recent therapy received.
- Cohort Expansion Concomitant Enzalutamide Group: Participant has progressed only once on prior second generation ARPI (prior abiraterone, darolutamide, or apalutamide is allowed, prior treatment with enzalutamide is not allowed). Note: First generation ARPI is allowed but not considered as prior ARPI. Second generation ARPI must be the most recent therapy received.
- Documented progressive mCRPC will be based on at least 1 of the following criteria:
- Serum/plasma prostate specific antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal value for study enrollment is 2.0 ng/mL;
- Soft-tissue progression defined as a ≥20% increase in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since the last treatment directed at the metastatic cancer has started (not including hormonal therapy) or the appearance of 1 or more new lesions;
- Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan.
- ≥1 metastatic lesion that is present at screening CT, magnetic resonance imaging (MRI), or bone scan imaging obtained ≤28 days prior to enrollment into the study;
- Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (prior chemotherapy, radiation, immunotherapy, etc.);
- Participants must have adequate organ function:
- Bone marrow reserve:
- White blood cell (WBC) count ≥2.5 x 109/L (2.5 x 109/L is equivalent to 2.5 x 103/μL and 2.5 x K/μL and 2.5 x 103/cc and 2500/μL) OR
- Absolute neutrophil count (ANC) ≥1.5 x 109 /L (1.5 x 109 /L is equivalent to 1.5 x 103 /μL and 1.5 x K/μL and 1.5 x 103 /cc and 1500/μL);
- Platelets ≥100 x 109 /L (100 x 109 /L is equivalent to 100 x 103 /μL and 100 x K/μL and 100 x 103 /cc and 100,000/μL);
- Hemoglobin ≥9 g/dL (5.59 mmol/L);
- Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted;
- Alanine aminotransferase or aspartate aminotransferase ≤3.0 x ULN OR ≤5.0 x ULN for participants with liver metastases;
- Creatinine clearance or estimated glomerular filtration rate ≥50 mL/min
- For participants who are human immunodeficiency virus infected: Participant must be healthy and have a low risk of Acquired Immune Deficiency Syndrome related outcomes in the opinion of the Investigator;
- For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.
Who cannot join
- Major surgery within 12 weeks prior to enrollment into the study;
- Brain metastasis;
- Histologic diagnosis of small cell or neuroendocrine prostate cancer;
- Prior history of leukemia or Myelodysplastic Syndrome;
- Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to enrollment into the study;
- Unmanageable urinary tract obstruction;
Show all 26Show fewer
- Evidence of progressive lesion(s) on MRI and/or CT (according to Response Evaluation Criteria in Solid Tumors V1.1) that is prostate-specific membrane antigen (PSMA) negative on the 1 hour 64Cu-SAR-bisPSMA PET/CT scan as determined at screening. NOTE: THIS CRITERION IS NOT APPLICABLE TO PARTICIPANTS IN THE 64Cu-SAR-bisPSMA DOSIMETRY PHASE AND DOSE ESCALATION PHASE.
- Previous treatment with a systemic radionuclide:
- Dose Escalation: Previous treatment with a systemic radionuclide, including 177Lu, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor;
- Cohort Expansion: Previous treatment with a systemic radionuclide, including Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor; Any previous PSMA targeted radionuclide therapy (including 177Lu and Actinium-225) is also excluded.
- Previous treatment with any systemic anti-cancer therapy (e.g. immunotherapy or biological therapy [including monoclonal antibodies]) within 4 weeks prior to treatment on study with the exception of Luteinizing Hormone Releasing Hormone (LHRH), any other androgen deprivation therapy (ADT) or low dose corticosteroids.
- Dose Escalation: prior treatment with chemotherapy within 4 weeks of first administration of 67Cu-SAR-bisPSMA is also excluded.
- Cohort Expansion: Prior treatment with cytotoxic chemotherapy for castration resistant PCa (e.g. taxanes, platinum, estramustine, vincristine, methotrexate, etc) is also excluded. Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with any poly (adenosine diphosphate-ribose) polymerase inhibitors (PARPi) is also excluded. NOTE: THIS CRITERION IS NOT APPLICABLE TO PARTICIPANTS IN THE 64Cu-SAR-bisPSMA DOSIMETRY PHASE;
- Previous treatment with any investigational agents within 4 weeks prior enrollment into the study;
- Known hypersensitivity to the components of the investigational products or its analogues;
- Transfusion for the sole purpose of making a participant eligible for study inclusion;
- Spinal metastasis with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression;
- Concurrent serious medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation;
- Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer;
- Any condition or personal situation that would pose an unacceptable radiation safety risk (as per institution guidelines, state and/or national regulations) to the participant or carer at the time of release following the completion of therapy (e.g. uncontrolled urinary incontinence, high dependency care);
- Participants in whom it is known that external beam radiation therapy is scheduled after enrollment into the study. NOTE: THIS CRITERION IS NOT APPLICABLE TO PARTICIPANTS IN THE 64Cu-SAR-bisPSMA DOSIMETRY PHASE.
- Participants in the Cohort Expansion Concomitant Enzalutamide Group:
- Participants with known hypersensitivity to enzalutamide or any of its ingredients.
- Participants with a history of seizures.
- Participants with a history of loss of consciousness (unless of cardiac origin) or transient ischemic attack within 12 months prior to enrolment into the study.
- Participants with conditions that increase the risk of seizures include those with a history of traumatic brain injury, stroke or cerebrovascular disease, arteriovenous malformations in the brain, neurodegenerative diseases, primary or metastatic brain tumors, active leptomeningeal disease, uncontrolled hypertension (systolic >179 or diastolic >105), patients undergoing alcohol withdrawal.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
BAMF Health
Grand Rapids, Michigan, 49503
Brandon Mancini
- Recruiting
Weill Cornell Medicine at New York-Presbyterian
New York, New York, 10021
Scott Tagawa, MD
- Recruiting
XCancer
Omaha, Nebraska, 68130
Tony Romero, 402-690-3716, tromero@gucancer.com
Luke Nordquist, MD
- Recruiting
East Jefferson General Hospital
River Ridge, Louisiana, 70123
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Geoffrey Johnson, MD
- Recruiting
Washington University School of Medicine at Barnes-Jewish Hospital
St Louis, Missouri, 63110
Vikas Prasad, MD
- Recruiting
Stanford Cancer Institute
Stanford, California, 94305
David Marcellus
Hong Song, MD
About this study
Official title: A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer
The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
- Being tested
- 64Cu-SAR-bisPSMA, 67Cu-SAR-bisPSMA
- Medical subject headings
- Prostatic Neoplasms, Castration-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-SAR-bisPSMADrug
64Cu-SAR-bisPSMA
67Cu-SAR-bisPSMADrug
67Cu-SAR-bisPSMA
| Study group | Role | What they receive |
|---|---|---|
| 67Cu-SAR-bisPSMA | Experimental | In the dosimetry phase patients will receive a single 200 MBq administration of 64Cu-SAR-bisPSMA.
In the dose escalation phase patients will receive up to 2 administrations of 200 MBq of 64Cu-SAR-bisPSMA.
In the cohort expansion phase patients will receive up to 3 administrations of 200 MBq of 64Cu-SAR-bisPSMA.
In the dose escalation phase patients will receive up to 4 administrations of 67Cu-SAR-bisPSMA (dose will be determined based on cohort allocation).
In the cohort expansion phase patients will receive up to 6 administrations of 67Cu-SAR-bisPSMA at the recommended dose level determined through dose escalation. Receives: Drug: 64Cu-SAR-bisPSMA; Drug: 67Cu-SAR-bisPSMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodistribution of 64Cu-SAR-bisPSMA
Biodistribution will be calculated by utilizing the PET/CT scans.
Measured: 48 hours
Dosimetry of 64Cu-SAR-bisPSMA
Dosimetry will be calculated by utilizing the PET/CT scans.
Measured: 48 hours
Modelling of 67Cu-SAR-bisPSMA dosimetry utilizing the 64Cu-SAR-bisPSMA PET/CT scans
Dosimetry will be calculated by utilizing the PET/CT scans.
Measured: 48 hours
Maximum Tolerated Dose (MTD) or Maximum Feasible Dose of a single dose of 67Cu-SAR-bisPSMA
MDT as determined by cohort observations of dose limiting toxicities (DLT)
Measured: 8 weeks
Recommended dose of two doses of 67Cu-SAR-bisPSMA
Recommended dose as determined by cohort observations of DLTs
Measured: 14 weeks
Efficacy of 67Cu-SAR-bisPSMA in terms of Prostate specific Antigen (PSA) response
Proportion of participants with ≥50% decline in PSA
Measured: Up to 5 years
Efficacy of 67Cu-SAR-bisPSMA in terms of radiographic response
Efficacy will be assessed via the overall response rate according to RECIST V1.1 for soft tissue disease and according PCWG3 for bone lesions
Measured: Up to 5 years
Incidence of 67Cu-SAR-bisPSMA Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events will be as assessed by CTCAE version 5.00
Measured: Up to 5 years
Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in Vital Signs
Change from baseline in vital signs
Measured: Up to 1 year
Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in electrocardiogram (ECG) parameters
Change from baseline in ECG parameters
Measured: Up to 24 weeks
Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in laboratory results
Change from baseline in laboratory results
Measured: Up to 22 weeks
Incidence of 64Cu-SAR-bisPSMA Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events will be as assessed by CTCAE version 5.00
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start11 Aug 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Neoplasms, Castration-ResistantStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is to be conducted in 3 phases, a dosimetry phase, a dose escalation phase and a cohort expansion phase.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clarity Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clarity Pharmaceuticals, Study director, Clarity Pharmaceuticals Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868604
- Sponsor's protocol ID
- CLP05
- Acronym
- SECuRE
- Status last verified
- May 2026
- First submitted
- 15 Apr 2021
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT04868604
- Acronym / sponsor ID
- SECuRE / CLP05
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Clarity Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 3 May 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.
The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is to be conducted in 3 phases, a dosimetry phase, a dose escalation phase and a cohort expansion phase.
| Arm | Type | Receives |
|---|---|---|
| 67Cu-SAR-bisPSMA | Experimental | Drug: 64Cu-SAR-bisPSMA, Drug: 67Cu-SAR-bisPSMAIn the dosimetry phase patients will receive a single 200 MBq administration of 64Cu-SAR-bisPSMA. In the dose escalation phase patients will receive up to 2 administrations of 200 MBq of 64Cu-SAR-bisPSMA. In the cohort expansion phase patients will receive up to 3 administrations of 200 MBq of 64Cu-SAR-bisPSMA. In the dose escalation phase patients will receive up to 4 administrations of 67Cu-SAR-bisPSMA (dose will be determined based on cohort allocation). In the cohort expansion phase patients will receive up to 6 administrations of 67Cu-SAR-bisPSMA at the recommended dose level determined through dose escalation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Signed informed consent;
- ≥18 years of age;
- Eastern Cooperative Oncology Group performance status of 0 to 2;
- Life expectancy >6 months;
- Histological, pathological, and/or cytological confirmation of Prostate cancer (PCa);
Key exclusion criteria (26 listed)
- Major surgery within 12 weeks prior to enrollment into the study;
- Brain metastasis;
- Histologic diagnosis of small cell or neuroendocrine prostate cancer;
- Prior history of leukemia or Myelodysplastic Syndrome;
- Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to enrollment into the study;
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-bisPSMA64Cu-SAR-bisPSMA | Drug | 67Cu-SAR-bisPSMA |
| 67Cu-SAR-bisPSMA67Cu-SAR-bisPSMA | Drug | 67Cu-SAR-bisPSMA |
Primary outcome
Biodistribution of 64Cu-SAR-bisPSMA
Time frame: 48 hours
Biodistribution will be calculated by utilizing the PET/CT scans.
Dosimetry of 64Cu-SAR-bisPSMA
Time frame: 48 hours
Dosimetry will be calculated by utilizing the PET/CT scans.
Modelling of 67Cu-SAR-bisPSMA dosimetry utilizing the 64Cu-SAR-bisPSMA PET/CT scans
Time frame: 48 hours
Dosimetry will be calculated by utilizing the PET/CT scans.
Maximum Tolerated Dose (MTD) or Maximum Feasible Dose of a single dose of 67Cu-SAR-bisPSMA
Time frame: 8 weeks
MDT as determined by cohort observations of dose limiting toxicities (DLT)
Recommended dose of two doses of 67Cu-SAR-bisPSMA
Time frame: 14 weeks
Recommended dose as determined by cohort observations of DLTs
Efficacy of 67Cu-SAR-bisPSMA in terms of Prostate specific Antigen (PSA) response
Time frame: Up to 5 years
Proportion of participants with ≥50% decline in PSA
Efficacy of 67Cu-SAR-bisPSMA in terms of radiographic response
Time frame: Up to 5 years
Efficacy will be assessed via the overall response rate according to RECIST V1.1 for soft tissue disease and according PCWG3 for bone lesions
Incidence of 67Cu-SAR-bisPSMA Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 5 years
Adverse Events will be as assessed by CTCAE version 5.00
Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in Vital Signs
Time frame: Up to 1 year
Change from baseline in vital signs
Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in electrocardiogram (ECG) parameters
Time frame: Up to 24 weeks
Change from baseline in ECG parameters
Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in laboratory results
Time frame: Up to 22 weeks
Change from baseline in laboratory results
Incidence of 64Cu-SAR-bisPSMA Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 5 years
Adverse Events will be as assessed by CTCAE version 5.00
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 6 May 2026.
Related trials for Prostatic Neoplasms, Castration-Resistant
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 2
Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Prostate Cancer
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.
Clarity Pharmaceuticals study director
Clarity Pharmaceuticals Ltd
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA in people with Prostatic Neoplasms, Castration-Resistant, run by Clarity Pharmaceuticals Ltd at 7 sites 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 28 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 6 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 7 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Clarity Pharmaceuticals (+61 (0) 2 9209 4037, clinicaltrials@claritypharmaceuticals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of 64Cu-SAR-bisPSMA (time frame: 48 hours). The study lists 12 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 6 May 2026.