64Cu-SAR-bisPSMA PET/CT for Prostate Cancer

(AMPLIFY Trial)

Recruiting at 2 trial locations

Overseen By Clarity Pharmaceuticals Clarity Clinical Trials Contact

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Clarity Pharmaceuticals Ltd

Must not be taking: Androgen-deprivation, Antiandrogen, Chemotherapy, others

Disqualifiers: Investigational agents, Systemic therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method called 64Cu-SAR-bisPSMA PET/CT to evaluate its effectiveness in detecting returning prostate cancer. The goal is to enhance the detection of cancer recurrence after initial treatment. This trial suits individuals who have undergone prostate cancer treatment, such as surgery or radiation, and now experience rising PSA levels, a protein in the blood that may indicate cancer presence. Participants should be willing to undergo additional tests, like a biopsy, if necessary. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking advancement in cancer detection.

Will I have to stop taking my current medications?

The trial requires that you stop any ongoing treatment or treatment within 6 months with systemic therapies for prostate cancer, such as hormone therapies or chemotherapy. If you're on these medications, you may need to stop them to participate.

What prior data suggests that 64Cu-SAR-bisPSMA PET/CT is safe for detecting prostate cancer recurrence?

Research has shown that 64Cu-SAR-bisPSMA is safe for humans. Studies have found that this treatment effectively identifies prostate cancer spots in patients and is well-tolerated, with no serious side effects reported. The FDA granted it a Fast Track Designation, highlighting its potential value and safety. Currently, this treatment is in a phase 3 trial, indicating it has already passed earlier safety tests. ^{1 2 3 4 5}

Why are researchers excited about this trial?

64Cu-SAR-bisPSMA is unique because it uses a novel radioactive tracer, copper-64, to target prostate-specific membrane antigen (PSMA) in prostate cancer cells. Most current treatments for prostate cancer involve hormonal therapies or chemotherapy, which work by slowing the growth of cancer cells or killing them directly. However, 64Cu-SAR-bisPSMA offers a different approach by highlighting cancer cells in PET/CT scans, potentially improving diagnostic accuracy and helping to tailor more effective treatment plans. Researchers are excited about this because it could lead to earlier detection and more personalized treatment strategies, improving outcomes for patients with prostate cancer.

What evidence suggests that 64Cu-SAR-bisPSMA PET/CT is effective for detecting prostate cancer recurrence?

Research has shown that 64Cu-SAR-bisPSMA, the investigational imaging agent studied in this trial, effectively identifies recurrent prostate cancer. It detects cancer cells 2 to 3 times better than some other methods. One study found cancer in up to 80% of participants who previously received negative results with standard imaging tests. This imaging agent also identifies more prostate cancer spots compared to the commonly used 68Ga-PSMA-11 PET/CT, particularly in patients with low PSA levels, which indicate prostate cancer activity. These findings support the use of 64Cu-SAR-bisPSMA for improved detection and understanding of prostate cancer. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for men who've had prostate cancer treatment but now have signs it might be coming back. They need a rising PSA level after surgery or radiation, cryotherapy, or brachytherapy. They should be healthy enough to live at least another 6 months and able to potentially undergo more treatment if needed.

Inclusion Criteria

I have signed the consent form.

My doctor believes I have at least 6 months to live.

1. 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 2. 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).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 64Cu-SAR-bisPSMA

Trial Overview

The study tests a new PET/CT scan using the tracer 64Cu-SAR-bisPSMA to find where prostate cancer might be returning in the body. Participants may also need a biopsy of any areas that light up on the scan to confirm if it's really cancer.

How Is the Trial Designed?

Group I: 64Cu-SAR-bisPSMA 200MBq 64Cu-SAR-bisPSMA. Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Clarity Pharmaceuticals Ltd

Lead Sponsor

Trials

11

Recruited

720+

Citations

1.

urotoday.com

urotoday.com/conference-highlights/asco-2025/asco-2025-prostate-cancer/161085-asco-2025-cobra-assessment-of-the-efficacy-of-64cu-sar-bispsma-using-histopathology-and-standard-of-care-imaging-as-reference-standard-in-patients-with-biochemical-recurrence-of-prostate-cancer-following-definitive-therapy.html

Assessment of the Efficacy of 64Cu-SAR-bisPSMA Using ...

Clinical evidence has shown that ⁶⁴Cu-SAR-bisPSMA achieves 2- to 3-fold higher tumor uptake on same-day imaging and enables detection of ...

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.5102

COBRA: Assessment of the efficacy of 64Cu-SAR-bisPSMA ...

Conclusions: 64Cu-SAR-bisPSMA is effective in detecting PC in BCR of PC, with lesions identified in up to 80% of participants with negative/ ...

3.

claritypharmaceuticals.com

claritypharmaceuticals.com/news/co-psma-endpoint/

Co-PSMA trial achieves primary endpoint

This result supports the hypothesis that 64Cu-SAR-bisPSMA can improve early detection of recurrence and staging of prostate cancer in patients ...

4.

cancernetwork.com

cancernetwork.com/view/64cu-sar-bispsma-pet-detects-more-prostate-cancer-lesions-vs-soc

64Cu-SAR-bisPSMA PET Detects More Prostate Cancer ...

The novel PET imaging agent detected significantly more PSMA-positive prostate cancer lesions vs SOC in patients with low PSA levels.

5.

onclive.com

onclive.com/view/64cu-sar-bispsma-bests-soc-68ga-psma-11-pet-ct-in-detecting-psma-positive-prostate-cancer-lesions

64Cu-SAR-bisPSMA Bests SOC 68Ga-PSMA-11 PET/CT ...

64Cu-SAR-bisPSMA outperformed 68Ga-PSMA-11 PET/CT in detecting PSMA-positive lesions in low PSA level patients, achieving the Co-PSMA trial's ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06970847

Study Details | NCT06970847 | 64Cu-SAR-bisPSMA ...

Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... Ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer.

7.

claritypharmaceuticals.com

claritypharmaceuticals.com/news/ftd-2/

Clarity receives U.S. FDA Fast Track Designation for Cu-64 ...

The US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 64 Cu-SAR-bisPSMA for positron emission tomography (PET) imaging.

8.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5100

Assessment of safety and efficacy of 64 Cu-SAR-bisPSMA ...

This study showed that 64 Cu-SAR-bisPSMA is safe and effective in detecting PC lesions in patients with BCR.

9.

urotoday.com

urotoday.com/conference-highlights/snmmi-2024/152784-snmmi-2024-cobra-assessment-of-safety-and-efficacy-of-64cu-sar-bispsma-in-patients-with-biochemical-recurrence-of-prostate-cancer-following-definitive-therapy.html

Assessment of Safety and Efficacy of 64Cu-SAR-bisPSMA ...

The COBRA study was a phase I/II study assessing the safety and efficacy of 64 Cu-SAR-bisPSMA (200 MBq) in prostate cancer patients with biochemical recurrence.