AS1986NS for Prostate Cancer

Recruiting at 1 trial location

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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS

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.

What data supports the effectiveness of the drug AS1986NS for prostate cancer?

The research on enzalutamide, a drug used in similar prostate cancer conditions, shows it significantly improves the time patients live without the cancer spreading. This suggests that AS1986NS, if similar to enzalutamide, might also be effective in treating prostate cancer. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Single dose of AS1986NS Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Antelope Surgical Solutions, Inc

Lead Sponsor

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Prostate cancer outcomes: the three questions. [2015]

2. Spain 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). [2021]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer. [2021]

5. England 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. [2021]