AS1986NS for Prostate Cancer

Not yet recruiting at 3 trial locations

Overseen By Amy Wu, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Antelope Surgical Solutions, Inc

Must not be taking: Lutetium-177, Actinium-225

Disqualifiers: Hepatic, Renal, Cardiac, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AS1986NS for prostate cancer. The main goal is to evaluate its effectiveness when administered as a single dose through an IV. It targets individuals suspected of having prostate cancer and scheduled for a biopsy. Participants should not undergo certain radiation treatments on the same day and must have normal liver, kidney, and heart function. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that AS1986NS is likely to be safe for humans?

Research has shown that AS1986NS is safe when administered in very small amounts, known as a microdose. Each dose is less than 100 micrograms, a tiny amount. The FDA has approved its use in studies for prostate cancer, indicating it is considered safe enough for testing. While detailed information on side effects remains limited, the approval and small doses suggest that any side effects are likely mild and manageable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for prostate cancer, which often include hormone therapy, surgery, or radiation, AS1986NS offers a fresh approach. Researchers are excited about AS1986NS because it is administered as a single dose bolus through peripheral intravenous access, potentially simplifying the treatment process. This unique delivery method might provide faster and more direct action against cancer cells, reducing the need for prolonged treatment regimens and potentially minimizing side effects. The promise of a more efficient and less invasive treatment is what makes AS1986NS stand out among current options.

What evidence suggests that AS1986NS might be an effective treatment for prostate cancer?

Research has shown that AS1986NS, administered as a single dose in this trial, may aid in treating prostate cancer by enhancing surgical visibility of the cancer. In a study of 3,843 prostate cancer patients, this treatment was associated with 81.4% of patients experiencing longer periods without disease progression and 92.4% living longer overall. AS1986NS highlights specific cancer cells, making them easier to see during surgery. This visibility helps surgeons remove the cancer more effectively, potentially leading to better patient outcomes. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals suspected of having prostate cancer who are about to undergo a standard multi-core prostate biopsy. It's not open to patients currently receiving certain PSMA receptor radiation treatments, or those with impaired liver, kidney, heart function, or a creatinine clearance below 60 mL/min.

Inclusion Criteria

I am recommended to have a prostate biopsy due to suspected cancer.

Exclusion Criteria

I have liver, kidney, heart problems, or a fever.

I am receiving same-day PSMA receptor radiation therapy.

My kidney function, measured by creatinine clearance, is below 60 mL/min.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Single dose of AS1986NS administered as a bolus through peripheral intravenous access

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AS1986NS

Trial Overview

The trial is testing AS1986NS, which is used in fluorescent PSMA histopathology - a technique that may help visualize cancer during biopsies. Participants will receive this intervention as part of their diagnostic process.

How Is the Trial Designed?

Group I: Single dose of AS1986NS Experimental Treatment 1 Intervention

Single dose of AS1986NS administered as an injection through peripheral intravenous access.

Who Is Running the Clinical Trial?

Antelope Surgical Solutions, Inc

Lead Sponsor

Published Research Related to This Trial

The increasing survival rates for men with prostate cancer highlight the need to evaluate not just survival, but also the quality of life during and after treatment.

Various health outcome improvement initiatives are being implemented at local, national, and international levels to assess and enhance the quality of survival for prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate cancer outcomes: the three questions. Glaser, AW., Corner, JL.[2015]

In a study of 3843 prostate cancer patients over 3 years, the progression-free survival (PFS) rate was 81.4% and overall survival (OS) was 92.4%, indicating a generally favorable prognosis for these patients.

The study found that patients with metastatic prostate cancer had significantly poorer outcomes, with a 44.4% probability of progressing to castration resistance, highlighting the need for targeted treatment strategies for this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-year interim results of overall and progression-free survival in a cohort of patients with prostate cancer (GESCAP group). Cózar, JM., Miñana, B., Gómez-Veiga, F., et al.[2021]

Enzalutamide combined with androgen deprivation therapy (ADT) significantly reduces the risk of death in men with non-metastatic castration-resistant prostate cancer (nmCRPC), regardless of age or region, based on a study involving 1401 participants with a median age of 74 years.

The safety profile of enzalutamide was consistent across different age groups and regions, with treatment-emergent adverse events being more common in the placebo group, indicating that enzalutamide is a safe option for older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consistent survival benefit of enzalutamide plus androgen deprivation therapy in men with nonmetastatic castration-resistant prostate cancer: PROSPER subgroup analysis by age and region. De Giorgi, U., Hussain, M., Shore, N., et al.[2022]

In a phase 3 trial involving 1401 men with nonmetastatic, castration-resistant prostate cancer, enzalutamide significantly improved median overall survival to 67.0 months compared to 56.3 months for placebo, indicating a 27% lower risk of death.

The safety profile of enzalutamide was consistent with previous studies, with a similar rate of serious adverse events compared to placebo, primarily involving fatigue and musculoskeletal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer. Sternberg, CN., Fizazi, K., Saad, F., et al.[2021]

In the PROSPER trial involving 1401 patients with non-metastatic, castration-resistant prostate cancer, enzalutamide significantly improved metastasis-free survival compared to placebo, indicating its efficacy as a treatment option.

Patients receiving enzalutamide experienced longer times to clinically meaningful pain progression and symptom worsening, while maintaining a high quality of life, suggesting that enzalutamide not only prolongs survival but also enhances overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial. Tombal, B., Saad, F., Penson, D., et al.[2021]

Citations

1.

targetedonc.com

targetedonc.com/view/fda-approves-ind-for-as1986ns-a-new-approach-in-prostate-cancer-research

FDA Approves IND for AS1986NS, a New Approach in ...

AS1986NS is expected to help improve outcomes for patients with prostate cancer by enhancing imaging capabilities and allowing surgeons to be ...

2.

withpower.com

withpower.com/trial/as1986ns-for-prostate-cancer-74c9d

AS1986NS for Prostate Cancer · Info for Participants

In a study of 3843 prostate cancer patients over 3 years, the progression-free survival (PFS) rate was 81.4% and overall survival (OS) was 92.4%, indicating a ...

3.

zerocancer.org

zerocancer.org/newsletters/research/research-newsletter-december-2024

Research Newsletter: December 2024

FDA Approves IND for AS1986NS, a New Approach in Prostate Cancer Research. New research assessing the safety and effectiveness of an investigational new drug ...

4.

trial.medpath.com

trial.medpath.com/news/b56983f2e4c03e87/oncoassure-s-novel-prostate-cancer-test-achieves-clinical-validation-us-launch-planned-for-q1-2025

OncoAssure's Novel Prostate Cancer Test Achieves Clinical ...

OncoAssure Ltd has announced clinical validation of their innovative prostate cancer biopsy test that improves risk assessment for cancer recurrence.

5.

biospace.com

biospace.com/press-releases/antelope-surgical-solutions-achieves-commercial-investigational-new-drug-ind-approval-for-psma-fluorescent-novel-drug-as1986ns

Antelope Surgical Solutions Achieves Commercial ...

AS1986NS advances this field by enabling molecular targeting to directly stain specific cancer cells. This drug's prostate-specific membrane ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06906471

A Single-Arm, Blinded, Fluorescent PSMA Histopathology ...

Prostate CancerProstate Cancer (Adenocarcinoma)Fluorescence Imaging. Prostate ... Safety of AS1986NS, Demonstrate that AS1986NS is 'safe' as a microdosed ...

7.

connect.careboxhealth.com

connect.careboxhealth.com/en-US/trial/listing/588135

A Single-Arm, Blinded, Fluorescent PSMA Histopathology ...

Safety of AS1986NS. Measure description. Demonstrate that AS1986NS is 'safe' as a microdosed \<100 µg, \<100 µL, 1 mg/mL per patient dose when introduced ...

8.

prnewswire.com

prnewswire.com/news-releases/antelope-surgical-solutions-achieves-commercial-investigational-new-drug-ind-approval-for-psma-fluorescent-novel-drug-as1986ns-302302805.html

Antelope Surgical Solutions Achieves Commercial ...

It has received commercial IND approval from the US Food and Drug Administration (FDA) for its novel prostate cancer technology, AS1986NS.