Enzalutamide for Prostate Cancer

Overseen By Elyse Watkins

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: Androgen deprivation therapy

Must not be taking: CYP2C8, CYP3A4 inducers/inhibitors

Disqualifiers: Metastatic castration-resistant prostate cancer, others

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

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

Compensation: Varies

Number of Visits: 29

Duration: 32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best dose of enzalutamide for treating advanced prostate cancer in older men. Enzalutamide manages prostate cancer by blocking male hormones. The study targets men aged 75 and older with advanced prostate cancer who have not yet started enzalutamide. Participants will assist researchers in determining the optimal dose for this age group. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

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

Previous studies have generally shown that enzalutamide is well-tolerated by patients with prostate cancer. For example, research involving 2,275 patients demonstrated that enzalutamide reduced the risk of death and had a safety profile similar to other treatments. Another study suggested that a lower dose of enzalutamide can maintain its effectiveness while potentially improving safety for some patients, particularly older ones. Additionally, long-term studies have consistently shown that enzalutamide remains safe for treating prostate cancer, even in older patients. While some side effects can occur, they are usually manageable. This evidence suggests that enzalutamide is relatively safe for treating prostate cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Enzalutamide is unique because it targets prostate cancer cells by inhibiting androgen receptors, which are crucial for the growth of cancer cells. Unlike traditional hormone therapies that might affect the production of androgens, enzalutamide works directly at the cellular level to block the cancer-fueling signals. Researchers are excited about this treatment because it offers a more direct approach to halting cancer progression, potentially leading to improved outcomes for patients with advanced prostate cancer. This novel mechanism of action sets it apart from existing therapies, providing hope for better management of the disease.

What is the effectiveness track record for enzalutamide in treating prostate cancer?

Studies have shown that enzalutamide effectively treats advanced prostate cancer. Research indicates that patients taking enzalutamide have a better chance of living longer and experiencing slower cancer growth compared to other treatments. For example, one study found that after 96 months, 50% of patients on enzalutamide were still alive, compared to 40% of those on a different treatment. Additionally, after five years, men treated with enzalutamide and ADT (androgen deprivation therapy) had a 66% survival rate, while those on hormone therapy alone had a 53% rate. These findings suggest that enzalutamide can help extend life and improve outcomes for men with advanced prostate cancer. Participants in this trial will be divided into two cohorts: the Main Cohort, which includes participants 75 years and older who have not yet started enzalutamide, and the Control Cohort, which includes participants under 70 years old who have been receiving enzalutamide for more than 29 days. ^{3 4 6 7 8}

Who Is on the Research Team?

Daniel Khalaf, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

Inclusion Criteria

I am a man who is 75 years old or older.

Signed Informed Consent Form

Signed Informed Consent Form

Exclusion Criteria

Main Cohort:

My cancer has spread to my spine and is about to compress my spinal cord.

I have a history of seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive enzalutamide at various dose levels to evaluate optimal dosing in elderly patients

32 weeks

Visits at day 29 and 57 for each dose level

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enzalutamide

How Is the Trial Designed?

Group I: Main Cohort Experimental Treatment 1 Intervention

Participants 75 years and older who have have a confirmed diagnosis of advanced prostate cancer, and are suitable candidates to receive enzalutamide but have not started treatment with the drug yet.

Group II: Control Cohort Active Control 1 Intervention

The control cohort will enroll participants that are under 70 years old, and are currently receiving enzalutamide for a period of more than 29 days.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6215909/

Enzalutamide therapy for advanced prostate cancer - PMC - NIH

PSA declines of at least 30% after 4 weeks and >30% or >50% after 12 weeks of treatment have been shown to correlate with a survival advantage especially in ...

2.

pfizer.com

pfizer.com/news/press-release/press-release-detail/astellas-and-pfizers-xtanditm-enzalutamide-shows-long-term

Astellas and Pfizer's XTANDI™ (enzalutamide) Shows ...

OS at 96 months was 50% with XTANDI and 40% for NSAA; progression-free survival (PFS) also favored XTANDI over NSAA (HR: 0.49; 95% CI, 0.42-0.57) ...

3.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2510310

Improved Survival with Enzalutamide in Biochemically ...

Overall survival was significantly longer with the combination of enzalutamide and leuprolide than with leuprolide alone among patients with ...

4.

xtandi.com

xtandi.com/clinical-trials

Clinical Trial Results | XTANDI® (enzalutamide)

In multiple clinical studies, XTANDI was proven to delay cancer progression and helped men live longer. Metastatic castration-sensitive prostate cancer (mCSPC).

5.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.10527

Efficacy and toxicity of low-doses versus standard- ...

This study evaluates the efficacy and safety of low/intermediate dose vs standard-dose enzalutamide in advanced PCa in a real-world Italian cohort.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40660075/

The efficacy and safety of enzalutamide in metastatic ...

Results: The data of 2275 patients were analyzed eventually. Enzalutamide reduced the risk of death by 33% compared to the control. Specifically ...

7.

mdpi.com

mdpi.com/1424-8247/18/5/732

Safety and Efficacy of Reduced Dose of Enzalutamide in ...

Conclusions: This systematic review suggests that reduced doses of Enzalutamide in CRPC may maintain therapeutic efficacy in selected patients while improving ...

8.

xtandihcp.com

xtandihcp.com/crpc/efficacy

Efficacy Results in CRPC

XTANDI + GnRH therapy* demonstrated consistent metastasis-free survival results in prespecified and stratified patient subgroups of PSA doubling time (< 6 ...