What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly those involving targeted radiotherapy using PSMA-binding ligands like 67Cu-SAR-bisPSMA, often have side effects such as fatigue, nausea, anemia, and bone marrow suppression. Other radioligand therapies, such as lutetium Lu 177 vipivotide tetraxetan, can also cause nephrotoxicity, salivary gland toxicity (dry mouth), and myelosuppression. Androgen deprivation therapy (ADT) may lead to hot flashes, decreased libido, and osteoporosis. Chemotherapy agents like docetaxel and cabazitaxel are associated with neuropathy, alopecia, and increased risk of infections due to immunosuppression.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that involve targeted radiotherapy using PSMA-binding ligands. One notable example is lutetium Lu 177 vipivotide tetraxetan, which targets PSMA-positive metastatic castration-resistant prostate cancer (CRPC). This treatment has shown significant improvements in radiographic progression-free survival and overall survival in clinical trials. Additionally, other treatments like radium-223 (Ra-223) have been used for bone metastases in CRPC, although they target bone rather than PSMA specifically. These approvals highlight the potential of targeted radiotherapy in managing advanced prostate cancer.

What other types of research exist?

Promising alternatives to 67Cu-SAR-bisPSMA for prostate cancer treatment include: <ol> <li>Lutetium Lu 177 vipivotide tetraxetan: A radioligand therapy that has shown higher likelihood of PSA decline and fewer adverse events compared to cabazitaxel in clinical trials.</li> <li></li> </ol> P-PSMA-101 CAR-T cells: An investigational immunotherapy targeting PSMA-expressing prostate cancer cells. 3. Beta-emitting radioisotopes like strontium-89 and samarium-153: These have been used clinically for bone metastases and may provide pain palliation. 4. BAT (Bipolar Androgen Therapy): Shown to restore sensitivity to abiraterone and enzalutamide in some patients with metastatic castration-resistant prostate cancer.

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Radioisotope Therapy

Cu-SAR-bisPSMA for Prostate Cancer (SECuRE Trial)

Q: What is the mechanism of action of this treatment?

Prostate cancer treatments, particularly targeted radiotherapies like 67Cu-SAR-bisPSMA, work by binding to Prostate-Specific Membrane Antigen (PSMA) expressed on cancer cells. This allows for the delivery of radioactive isotopes directly to the tumor, minimizing damage to surrounding healthy tissue. Other common treatments include androgen receptor inhibitors (e.g., enzalutamide) that block the effects of androgens, and chemotherapy agents (e.g., docetaxel) that kill rapidly dividing cells. These mechanisms are crucial as they offer targeted, effective options for managing prostate cancer, especially in advanced stages where traditional therapies may be less effective.

Phase 1 & 2

Recruiting

Research Sponsored by Clarity Pharmaceuticals Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L)

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

Must not have

Participants in whom it is known that external beam radiation therapy is scheduled after enrollment into the study.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new radioactive treatment called 67Cu-SAR-bisPSMA in patients with advanced prostate cancer that has spread and does not respond to hormone treatments. The treatment works by sticking to cancer cells and using radioactivity to destroy them.

Who is the study for?

Men over 18 with metastatic castrate resistant prostate cancer that's gotten worse despite treatment, and who have a certain level of organ function. They must not have brain metastases, small cell or neuroendocrine prostate cancer, recent major surgery, or other serious health issues. Participants need to use birth control if applicable.

What is being tested?

The trial is testing the safety and effectiveness of two radioactive drugs called 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA in targeting and treating advanced prostate cancer that shows up on special PET/CT scans.

What are the potential side effects?

Potential side effects may include reactions at the injection site, nausea, fatigue, blood count changes which could lead to increased infection risk or bleeding problems. There might also be kidney function changes due to the drug's radioactivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My testosterone levels are very low.

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My PET/CT scan shows a lesion with higher activity than my liver.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer has grown by 20% or more, or I have new cancer spots since my last treatment.

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My prostate cancer is worsening despite hormone therapy and treatments like enzalutamide or abiraterone.

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My prostate cancer diagnosis was confirmed through lab tests.

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My cancer has spread to my bones or gotten worse.

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My kidneys are functioning well.

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My liver enzymes are within the required limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for external beam radiation therapy after joining the study.

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I haven't had certain radioactive treatments in the last 3-6 months.

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I have a severe blockage in my urinary tract that can't be easily treated.

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I have not received a transfusion just to qualify for this study.

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I have cancer that has spread to my brain.

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I have had leukemia or Myelodysplastic Syndrome in the past.

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My prostate cancer is of the small cell or neuroendocrine type.

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My scans show my cancer is growing and does not show up on a specific PET/CT scan.

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I was diagnosed with a blood clot in my leg or lung in the last 4 weeks.

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I have cancer spread to my spine causing or threatening to cause spinal cord pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biodistribution of 64Cu-SAR-bisPSMA

Dosimetry of 64Cu-SAR-bisPSMA

Efficacy of 67Cu-SAR-bisPSMA in terms of Prostate specific Antigen (PSA) response

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 67Cu-SAR-bisPSMAExperimental Treatment2 Interventions

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 2 administrations of 67Cu-SAR-bisPSMA (dose will be determined based on cohort allocation). In the cohort expansion phase patients will receive 2 administrations of 67Cu-SAR-bisPSMA at the recommended dose level determined through dose escalation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

64Cu-SAR-bisPSMA

2022

Completed Phase 2

~90

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments, particularly targeted radiotherapies like 67Cu-SAR-bisPSMA, work by binding to Prostate-Specific Membrane Antigen (PSMA) expressed on cancer cells. This allows for the delivery of radioactive isotopes directly to the tumor, minimizing damage to surrounding healthy tissue. Other common treatments include androgen receptor inhibitors (e.g., enzalutamide) that block the effects of androgens, and chemotherapy agents (e.g., docetaxel) that kill rapidly dividing cells. These mechanisms are crucial as they offer targeted, effective options for managing prostate cancer, especially in advanced stages where traditional therapies may be less effective.

Biomarkers to personalize treatment with 177Lu-PSMA-617 in men with metastatic castration-resistant prostate cancer - a state of the art review.