Prostate Cancer (Post Prostatectomy)Phase 2Co-PSMANCT06907641
Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy
A Phase 2 study testing 64Cu-SAR-bisPSMA in people with Prostate Cancer (Post Prostatectomy), run by St Vincent's Hospital, Sydney at 1 site in Australia.
Trial summary
The goal of this clinical trial is to compare 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT in men with biochemical failure following radical prostatectomy. The main questions it aims to answer are: Is there a difference in the number of lesions of prostate cancer recurrence detected between the 64Cu-SAR-bisPSMA… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Post Prostatectomy)
- What is being tested?
- 64Cu-SAR-bisPSMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- 21 Nov 2024to 3 Sep 2025
- Phase
- Phase 2
- 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
- Male patients aged 18 or above
- Ability to provide informed consent documentation indicating that they understand the purpose of, and procedures required for the study, and are willing to participate in the study.
- Prior radical prostatectomy for confirmed adenocarcinoma on histopathology.
- Rising PSA (0.20 - 0.75 ng/mL) following radical prostatectomy with no prior salvage radiotherapy.
- 68Ga PSMA-11 PET/CT within the last 4 weeks for prostate cancer biochemical recurrence.
Who cannot join
- Prior, or contraindication to, salvage radiotherapy for biochemically recurrent prostate cancer.
- History of current active malignancy as per investigator discretion other than prostate cancer.
- Known or expected hypersensitivity to 64Cu-SAR-bisPSMA
- Systemic therapy for metastatic prostate cancer including androgen deprivation therapy.
Trial locations and contacts
1 site in 1 country.
Australia1 site
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, 2010
About this study
The goal of this clinical trial is to compare 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT in men with biochemical failure following radical prostatectomy. The main questions it aims to answer are:
- Is there a difference in the number of lesions of prostate cancer recurrence detected between the 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT scans.
- What is the diagnostic accuracy of 64Cu-SAR-bisPSMA PET/CT compared to 68Ga PSMA-11 PET/CT using a standard of care comparator.
- Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11).
Read more
Participants will:
- have 3 visits: 1) standard of care 68Ga PSMA-11 dose and PET/CT scan; 2) 64Cu-SAR-bisPSMA dose and PET/CT; 3) 64Cu-SAR-bisPSMA PET/CT only
- have standard of care blood test either at Visit 1 or Visit 2
- Conditions
- Prostate Cancer (Post Prostatectomy)
- Being tested
- 64Cu-SAR-bisPSMA
- Keywords
- Prostate Cancer, Salvage Radiotherapy, Prostatectomy, Co-PSMA, CLP11, Prostate Cancer Recurrence, Biochemical Failure, Radical Prostatectomy, Copper, PET scan
- 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 participants will receive a single administration of 200 MBq of 64Cu-SAR-bisPSMA
| Study group | Role | What they receive |
|---|---|---|
| 64Cu-SAR-bisPSMA | Experimental | 200MBq 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.
Detection rate of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT
Compare the detection rate of sites of prostate cancer recurrence, as determined by number of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT in patients with biochemical recurrence following radical prostatectomy who are being considered for curative salvage radiotherapy.
Measured: 12 months
Secondary outcomes (6)
Compare the number of lesions outside of the prostatic fossa per patient between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT.
Measured: 12 months
Compare the diagnostic accuracy of 64Cu-SAR-bisPSMA versus 68Ga PSMA-11 PET/CT in the detection of recurrent or metastatic prostate cancer using a composite standard of truth
Compare the diagnostic accuracy of 64Cu-SAR-bisPSMA versus 68Ga PSMA-11 PET/CT in the detection of recurrent or metastatic prostate cancer using a composite standard of truth (biopsy, concurrent imaging and response to targeted therapy).
Measured: 12 months
Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11).
Measured: 12 months
Compare the total number of lesions between 1 to 4-hour, and 24-hour 64Cu-SAR-bisPSMA PET/CT imaging timepoints.
Measured: 12 months
Evaluate the frequency of prostatic fossa recurrence on the 24-hour 64Cu-SAR-bisPSMA images compared to the 1 to 4-hour 64Cu-SAR-bisPSMA and 1-hour 68Ga PSMA-11 PET/CT images
Measured: 12 months
Evaluate biochemical (PSA) response following salvage radiotherapy by 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT imaging parameters in the presence of normal testosterone levels.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start21 Nov 2024
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
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 Prostate Cancer (Post Prostatectomy)Studies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital, Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Clarity Pharmaceuticals Ltd
- Responsible party
- Principal investigator, Louise Emmett, St Vincent's Hospital, Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907641
- Sponsor's protocol ID
- CLP11 (Co-PSMA)
- Other IDs
- CT-2024-CTN-06035-1
- Acronym
- Co-PSMA
- Status last verified
- Aug 2026
- First submitted
- 26 Mar 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khan S, Papa N, Kneebone A, Eade T, Ayati N, Nguyen A, Wong K, Chen J, Ho B, Idiare J, Sidhom G, Roberts MJ, Thompson J, Sharma S, Weir S, Devitt K, Kooner R, Lieng H, Rasiah K, Olphert J, de Leon J, Hruby G, Stricker P, Emmett L. Prospective Comparison of 64Copper [64Cu]SAR-bisPSMA vs 68Gallium[68Ga] PSMA-11 PET/CT for Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy (Co-PSMA Trial). Eur Urol. 2026 Jun;89(6):512-520. doi: 10.1016/j.eururo.2026.03.001. Epub 2026 Mar 28.
PubMed 41904043
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT06907641
- Acronym / sponsor ID
- Co-PSMA / CLP11 (Co-PSMA)
- Conditions
- Prostate Cancer (Post Prostatectomy)
- Keywords
- Prostate Cancer, Salvage Radiotherapy, Prostatectomy, Co-PSMA, CLP11, Prostate Cancer Recurrence, Biochemical Failure, Radical Prostatectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- St Vincent's Hospital, SydneyUniversity, hospital or other
- Collaborators
- Clarity Pharmaceuticals Ltd
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 2 Apr 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 goal of this clinical trial is to compare 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT in men with biochemical failure following radical prostatectomy. The main questions it aims to answer are:
- Is there a difference in the number of lesions of prostate cancer recurrence detected between the 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT scans.
- What is the diagnostic accuracy of 64Cu-SAR-bisPSMA PET/CT compared to 68Ga PSMA-11 PET/CT using a standard of care comparator.
- Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11).
Participants will:
- have 3 visits: 1) standard of care 68Ga PSMA-11 dose and PET/CT scan; 2) 64Cu-SAR-bisPSMA dose and PET/CT; 3) 64Cu-SAR-bisPSMA PET/CT only
- have standard of care blood test either at Visit 1 or Visit 2
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 | Experimental | Drug: 64Cu-SAR-bisPSMA200MBq 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 (5 listed)
- Male patients aged 18 or above
- Ability to provide informed consent documentation indicating that they understand the purpose of, and procedures required for the study, and are willing to participate in the study.
- Prior radical prostatectomy for confirmed adenocarcinoma on histopathology.
- Rising PSA (0.20 - 0.75 ng/mL) following radical prostatectomy with no prior salvage radiotherapy.
- 68Ga PSMA-11 PET/CT within the last 4 weeks for prostate cancer biochemical recurrence.
Key exclusion criteria (4 listed)
- Prior, or contraindication to, salvage radiotherapy for biochemically recurrent prostate cancer.
- History of current active malignancy as per investigator discretion other than prostate cancer.
- Known or expected hypersensitivity to 64Cu-SAR-bisPSMA
- Systemic therapy for metastatic prostate cancer including androgen deprivation therapy.
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 participants will receive a single administration of 200 MBq of 64Cu-SAR-bisPSMA | Drug | 64Cu-SAR-bisPSMA |
Primary outcome
Detection rate of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT
Time frame: 12 months
Compare the detection rate of sites of prostate cancer recurrence, as determined by number of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT in patients with biochemical recurrence following radical prostatectomy who are being considered for curative salvage radiotherapy.
6 secondary outcomes
Compare the number of lesions outside of the prostatic fossa per patient between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT.
Time frame: 12 months
Compare the diagnostic accuracy of 64Cu-SAR-bisPSMA versus 68Ga PSMA-11 PET/CT in the detection of recurrent or metastatic prostate cancer using a composite standard of truth
Time frame: 12 months
Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11).
Time frame: 12 months
Compare the total number of lesions between 1 to 4-hour, and 24-hour 64Cu-SAR-bisPSMA PET/CT imaging timepoints.
Time frame: 12 months
Evaluate the frequency of prostatic fossa recurrence on the 24-hour 64Cu-SAR-bisPSMA images compared to the 1 to 4-hour 64Cu-SAR-bisPSMA and 1-hour 68Ga PSMA-11 PET/CT images
Time frame: 12 months
Evaluate biochemical (PSA) response following salvage radiotherapy by 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT imaging parameters in the presence of normal testosterone levels.
Time frame: 12 months
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 14 Aug 2026.
- Derived from this study: PubMed 41904043Khan S, Papa N, Kneebone A, Eade T, Ayati N, Nguyen A, Wong K, Chen J, Ho B, Idiare J, Sidhom G, Roberts MJ, Thompson J, Sharma S, Weir S, Devitt K, Kooner R, Lieng H, Rasiah K, Olphert J, de Leon J, Hruby G, Stricker P, Emmett L. Prospective Comparison of 64Copper [64Cu]SAR-bisPSMA vs 68Gallium[68Ga] PSMA-11 PET/CT for Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy (Co-PSMA Trial). Eur Urol. 2026 Jun;89(6):512-520. doi: 10.1016/j.eururo.2026.03.001. Epub 2026 Mar 28.
Related trials for Prostate Cancer (Post Prostatectomy)
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Not yet recruiting
SURPASS: Stereotactic Ultra-hypofractionated Radiotherapy for Post-prostatectomy Patients: Adaptive Salvage SBRT
Prostate Adenocarcinoma
Active, not recruitingPhase 2
Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy
Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8
Not yet recruiting
Non-inferiority Trial Omitting Drainage After Robot-assisted Radical prostatectomY
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. 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 Phase 2 study testing 64Cu-SAR-bisPSMA in people with Prostate Cancer (Post Prostatectomy), run by St Vincent's Hospital, Sydney at 1 site 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 5 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: finished, as of the sponsor's last update on 14 Aug 2026. 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 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 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?
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?
Detection rate of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT (time frame: 12 months). 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 NCT06907641, 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 14 Aug 2026.