Prostatic NeoplasmsPhase 1PROPELLERNCT04839367
Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)
A Phase 1 study testing 64Cu-SAR-bisPSMA in people with Prostatic Neoplasms, run by Clarity Pharmaceuticals Ltd at 3 sites in Australia.
Trial summary
The aim of this study is to determine the safety and tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed 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
- 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
- 30 participants
- Where
- 3 sitesAustralia
- Study dates
- 13 Jul 2021to 19 Oct 2022
- Phase
- 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
- Signed informed consent;
- ≥18 years of age;
- Life expectancy >3 months;
- Confirmation of Prostate Cancer by histopathology and planned radical prostatectomy;
- Have ≥1 of the following intermediate- to high-risk features:
- PSA level greater than or equal to 10.0 ng/ml within 12 weeks prior to enrolment;
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- International Society of Urological Pathology (ISUP) Grade Group 3 (i.e. Gleason score of 7 (4+3) or above;
- Clinical stage greater than or equal to T2b;
- Participants must have adequate renal function;
- Sexually active participants who have female partners of childbearing potential: Partner and/or participant must agree to use an acceptable form of contraception. Further participants must refrain from donating sperm;
- A 68Ga-PSMA-11 PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SAR-bisPSMA.
Who cannot join
- Prior prostatectomy or any other treatment for Prostate Cancer, including Androgen Deprivation Therapy and radiation therapy;
- Previous treatment with PSMA-targeted therapy within 3 months prior to enrolment, and administration of other investigational agents within 4 weeks prior to entering the study (except 68Ga-PSMA-11);
- Known hypersensitivity to the components of 64Cu-SAR-bisPSMA;
- 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 serious medical condition which the Investigator feels may interfere with the procedures or evaluations of the study;
- Patients unwilling or unable to comply with protocol or with a history of noncompliance or inability to grant informed consent.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Nepean Hospital
Kingswood, New South Wales, 2751
GenesisCare CTA, SJOG Medical Clinic
Murdoch, Western Australia, 6150
St. Vincent's Hospital
Sydney, New South Wales, 2010
About this study
Official title: Positron Emission Tomography Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA: A Multi-Centre, Blinded Review, Dose Ranging Phase I Study
The aim of this study is to determine the safety and tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer.
Read the detailed description
This is a multi-centre, blinded review, dose ranging, non-randomized study of 64Cu-SAR-bisPSMA administered to participants with confirmed Prostate Cancer. 30 eligible participants will be allocated (1:1:3) to 1 of 3 dosing cohorts to be administered with 64Cu-SAR-bisPSMA 100 MBq, 150 MBq or 200 MBq. PET/CT scan images will be sent to blinded central readers to assess the capacity of 64Cu-SAR-bisPSMA to detect primary Prostate Cancer, to assess image quality of the various dose cohorts, and to assess the PET/CT scan features of 64Cu-SAR-bisPSMA in comparison standard of care.
- Conditions
- Prostatic Neoplasms
- Being tested
- 64Cu-SAR-bisPSMA
- 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
64Cu-SAR-bisPSMA
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA | Experimental | Participants will receive a single administration, a bolus injection of 100 MBq 64Cu-SAR-bisPSMA. Receives: Drug: 64Cu-SAR-bisPSMA |
| Cohort 2 - 150 MBq 64Cu-SAR-bisPSMA | Experimental | Participants will receive a single administration, a bolus injection of 150 MBq 64Cu-SAR-bisPSMA. Receives: Drug: 64Cu-SAR-bisPSMA |
| Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA | Experimental | Participants will receive a single administration, a bolus injection of 200 MBq 64Cu-SAR-bisPSMA. Receives: Drug: 64Cu-SAR-bisPSMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5
Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.
Measured: 11 weeks
Efficacy of 64Cu-SAR-bisPSMA in the Detection of Primary Prostate Caner Compared to Histopathology
Efficacy will be measured by the proportion of 64Cu-SAR-bisPSMA PET/CT scans assessed as True Positive or False Negative for primary Prostate Cancer, as confirmed by histopathology.
Measured: 11 weeks
Secondary outcomes (1)
Comparison of image quality at varying dose levels of 64CuSAR-bisPSMA for each dose cohort (100 MBq, 150 MBq and 200 MBq).
Image quality will be assessed by 2 blinded central readers.
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start13 Jul 2021
- Primary completion19 Oct 2022
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarity Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839367
- Sponsor's protocol ID
- CLP03
- Acronym
- PROPELLER
- Status last verified
- Jan 2023
- First submitted
- 7 Apr 2021
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lengyelova E, Patel M, Morrish G, Mittra E, Malaroda A, Gervasio O, Armor T. Optimization of Administered Activity for 64 Cu-SAR-bisPSMA PET Imaging in Primary Prostate Cancer: Results from a Phase I Retrospective Study (PROPELLER Sub-study). World J Nucl Med. 2026 Jun 23;25(2):107-114. doi: 10.1055/s-0046-1824335. eCollection 2026 Jun.
PubMed 42395167
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA: A Multi-Centre, Blinded Review, Dose Ranging Phase I Study
- ClinicalTrials.gov ID
- NCT04839367
- Acronym / sponsor ID
- PROPELLER / CLP03
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clarity Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 9 Apr 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 tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer.
Detailed description
This is a multi-centre, blinded review, dose ranging, non-randomized study of 64Cu-SAR-bisPSMA administered to participants with confirmed Prostate Cancer. 30 eligible participants will be allocated (1:1:3) to 1 of 3 dosing cohorts to be administered with 64Cu-SAR-bisPSMA 100 MBq, 150 MBq or 200 MBq. PET/CT scan images will be sent to blinded central readers to assess the capacity of 64Cu-SAR-bisPSMA to detect primary Prostate Cancer, to assess image quality of the various dose cohorts, and to assess the PET/CT scan features of 64Cu-SAR-bisPSMA in comparison standard of care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA | Experimental | Drug: 64Cu-SAR-bisPSMAParticipants will receive a single administration, a bolus injection of 100 MBq 64Cu-SAR-bisPSMA. |
| Cohort 2 - 150 MBq 64Cu-SAR-bisPSMA | Experimental | Drug: 64Cu-SAR-bisPSMAParticipants will receive a single administration, a bolus injection of 150 MBq 64Cu-SAR-bisPSMA. |
| Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA | Experimental | Drug: 64Cu-SAR-bisPSMAParticipants will receive a single administration, a bolus injection of 200 MBq 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 (11 listed)
- Signed informed consent;
- ≥18 years of age;
- Life expectancy >3 months;
- Confirmation of Prostate Cancer by histopathology and planned radical prostatectomy;
- Have ≥1 of the following intermediate- to high-risk features:
Key exclusion criteria (6 listed)
- Prior prostatectomy or any other treatment for Prostate Cancer, including Androgen Deprivation Therapy and radiation therapy;
- Previous treatment with PSMA-targeted therapy within 3 months prior to enrolment, and administration of other investigational agents within 4 weeks prior to entering the study (except 68Ga-PSMA-11);
- Known hypersensitivity to the components of 64Cu-SAR-bisPSMA;
- 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 serious medical condition which the Investigator feels may interfere with the procedures or evaluations of 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 | Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA, Cohort 2 - 150 MBq 64Cu-SAR-bisPSMA, Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA |
Primary outcome
Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5
Time frame: 11 weeks
Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.
Efficacy of 64Cu-SAR-bisPSMA in the Detection of Primary Prostate Caner Compared to Histopathology
Time frame: 11 weeks
Efficacy will be measured by the proportion of 64Cu-SAR-bisPSMA PET/CT scans assessed as True Positive or False Negative for primary Prostate Cancer, as confirmed by histopathology.
1 secondary outcome
Comparison of image quality at varying dose levels of 64CuSAR-bisPSMA for each dose cohort (100 MBq, 150 MBq and 200 MBq).
Time frame: 11 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 17 Jan 2023.
- Derived from this study: PubMed 42395167Lengyelova E, Patel M, Morrish G, Mittra E, Malaroda A, Gervasio O, Armor T. Optimization of Administered Activity for 64 Cu-SAR-bisPSMA PET Imaging in Primary Prostate Cancer: Results from a Phase I Retrospective Study (PROPELLER Sub-study). World J Nucl Med. 2026 Jun 23;25(2):107-114. doi: 10.1055/s-0046-1824335. eCollection 2026 Jun.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 64Cu-SAR-bisPSMA in people with Prostatic Neoplasms, run by Clarity Pharmaceuticals Ltd at 3 sites in Australia.
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 11 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 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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 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.
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?
Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5 (time frame: 11 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04839367, which also lists 1 linked publication.
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 17 Jan 2023.