132 Participants Needed

Enzalutamide + Standard Therapy for Prostate Cancer

(DIRECT Trial)

Recruiting at 1 trial location
RG
AM
Overseen ByAndrew McPartlin, MD
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: University Health Network, Toronto
Must be taking: Hormone therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if adding enzalutamide, a pill that blocks male hormones, to standard radiation and hormone treatments can improve the quality of life for prostate cancer patients. Participants will receive treatments and be monitored over several months and years to see how they do. Enzalutamide is an antiandrogen used to treat both metastatic and nonmetastatic prostate cancer.

Will I have to stop taking my current medications?

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 the combination of Enzalutamide and standard therapy for prostate cancer safe?

Enzalutamide, used in prostate cancer treatment, has been associated with severe thrombocytopenia (low platelet count) and seizures in some cases. Additionally, there are cardiovascular risks linked to androgen deprivation therapy (ADT), which is often part of the treatment.12345

How is the treatment with Enzalutamide and Standard Therapy unique for prostate cancer?

This treatment is unique because it combines enzalutamide, a newer androgen receptor-targeting drug, with standard therapies to improve survival in men with metastatic hormone-sensitive prostate cancer, outperforming older nonsteroidal antiandrogen drugs.34678

What data supports the effectiveness of the drug enzalutamide in treating prostate cancer?

Research shows that adding enzalutamide to standard treatment for men with metastatic hormone-sensitive prostate cancer helps them live longer compared to older drugs. Additionally, enzalutamide combined with androgen deprivation therapy (ADT) improves the time patients live without the cancer getting worse.134910

Are You a Good Fit for This Trial?

Men over 18 with a specific type of prostate cancer that has spread only slightly (oligometastatic) and who haven't had certain other cancers or treatments in the last 5 years. They should be relatively healthy, able to consent, and not on continuous hormone therapy for their cancer.

Inclusion Criteria

I have been diagnosed with prostate cancer.
Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR)
I choose not to use hormone therapy continuously.
See 6 more

Exclusion Criteria

I have had treatment to control cancer after the first treatment failed.
I haven't had any cancer except for non-melanoma skin cancer or in-situ cancer in the last 5 years.
I have health issues that make me unsuitable for certain prostate cancer treatments.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care radiation and hormone (ADT) therapy, with or without oral abiraterone for 8-9 months

8-9 months
2-5 sessions of radiation daily or every other day

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Routine follow-up in clinic or remotely

What Are the Treatments Tested in This Trial?

Interventions

  • ADT
  • Enzalutamide
  • Standard of Care SBRT
Trial Overview The trial is testing if adding a drug called Enzalutamide to standard radiation and hormone therapy improves life quality for men with limited-spread prostate cancer. Participants are randomly chosen to receive either just the standard treatment or the standard plus Enzalutamide for eight months.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm 3 - Study TreatmentExperimental Treatment2 Interventions
Group II: Arm 1 - Standard of CareExperimental Treatment1 Intervention

ADT is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Androgen Deprivation Therapy for:
🇺🇸
Approved in United States as Androgen Deprivation Therapy for:
🇨🇦
Approved in Canada as Androgen Deprivation Therapy for:
🇯🇵
Approved in Japan as Androgen Deprivation Therapy for:
🇨🇳
Approved in China as Androgen Deprivation Therapy for:
🇨🇭
Approved in Switzerland as Androgen Deprivation Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Astellas Pharma Inc

Industry Sponsor

Trials
700
Recruited
236,000+
Headquarters
Tokyo, Japan
Top Products
- Xtandi (enzalutamide) for prostate cancer, - Xospata (gilteritinib) for AML, - Padcev (enfortumab vedotin) for bladder cancer, - Prograf (tacrolimus) for organ rejection prevention
Tadaaki Taniguchi profile image

Tadaaki Taniguchi

Astellas Pharma Inc

Chief Medical Officer since 2023

MD, PhD

Naoki Okamura profile image

Naoki Okamura

Astellas Pharma Inc

Chief Executive Officer since 2023

University of Tokyo, Faculty of Pharmacy

Published Research Related to This Trial

The ENZAMET phase III trial demonstrated that adding enzalutamide to standard treatment significantly prolongs survival in men with metastatic hormone-sensitive prostate cancer.
Enzalutamide is more effective than older nonsteroidal antiandrogen drugs, highlighting its potential as a superior treatment option for this patient population.
Enzalutamide Bests Older NSAAs in mHSPC.[2021]
In the ARCHES study involving 1150 patients with metastatic hormone-sensitive prostate cancer, the addition of enzalutamide to androgen deprivation therapy (ADT) significantly delayed the worsening of pain and maintained health-related quality of life (HRQoL) compared to placebo.
While there were no significant differences in overall HRQoL scores between the enzalutamide and placebo groups, enzalutamide specifically delayed the time to first deterioration in pain severity and quality of life measures, indicating its potential to improve patient comfort during treatment.
Effect of Enzalutamide plus Androgen Deprivation Therapy on Health-related Quality of Life in Patients with Metastatic Hormone-sensitive Prostate Cancer: An Analysis of the ARCHES Randomised, Placebo-controlled, Phase 3 Study.Stenzl, A., Dunshee, C., De Giorgi, U., et al.[2021]
In the phase 3 ARCHES trial involving 1150 patients with metastatic hormone-sensitive prostate cancer (mHSPC), enzalutamide combined with androgen deprivation therapy (ADT) significantly improved radiographic progression-free survival (rPFS) with a hazard ratio of 0.39, indicating a strong reduction in the risk of disease progression.
The efficacy of enzalutamide plus ADT was consistent across various patient subgroups, including those with different prior treatments, disease volumes, and risk levels, demonstrating its broad clinical benefit for mHSPC patients.
Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk.Azad, AA., Armstrong, AJ., Alcaraz, A., et al.[2022]

Citations

Enzalutamide Bests Older NSAAs in mHSPC. [2021]
Effect of Enzalutamide plus Androgen Deprivation Therapy on Health-related Quality of Life in Patients with Metastatic Hormone-sensitive Prostate Cancer: An Analysis of the ARCHES Randomised, Placebo-controlled, Phase 3 Study. [2021]
Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk. [2022]
Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol. [2023]
PSA declines and survival in patients with metastatic castration-resistant prostate cancer treated with enzalutamide: A retrospective case-report study. [2022]
Enzalutamide-induced severe thrombocytopenia complicated by a seizure in a 76-year-old man with castration-resistant prostate cancer. [2022]
Cardiovascular toxicities associated with abiraterone compared to enzalutamide-A pharmacovigilance study. [2022]
Current androgen receptor antagonists under investigation for resistant prostate cancer. [2022]
The Effect of Time to Castration Resistance on Outcomes With Abiraterone and Enzalutamide in Metastatic Prostate Cancer. [2021]
Clinical and immunologic impact of short-course enzalutamide alone and with immunotherapy in non-metastatic castration sensitive prostate cancer. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security