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Androgen Receptor Inhibitor

Darolutamide + SBRT for Prostate Cancer

Phase 2
Recruiting
Led By Tamim Niazi, MD
Research Sponsored by Sir Mortimer B. Davis - Jewish General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
M0CRPC at study entry defined as follows: Ongoing androgen deprivation therapy with a LHRH agonist or bilateral orchiectomy (i.e., surgical or medical castration); Serum testosterone level ≤ 1.7 nmol/L (50 ng/dL) at the Screening visit; PSA progression defined by a minimum of two subsequent rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen must have progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since last bicalutamide or nilutamide). The PSA value at the Screening visit should be ≥ 2 μg/L (2 ng/mL) PSA doubling time of 10 months or less, M0 assessed by conventional imaging (CT/MRI + bone scan). Prior cytotoxic chemotherapy for prostate cancer in adjuvant setting post radical therapy is allowed; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 or Karnofsky performance status of > 80% or higher; Estimated life expectancy of ≥ 6 months; Ability to swallow the study drug whole and comply with study. Patients should not have been previously exposed to other ARATs (Abiraterone, Enzalutamide, Apalutamide)
Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
Must not have
Known or suspected brain metastasis or active leptomeningeal disease; > 5 metastasis; More than 4 metastasis in the same organ; Patients considered for SBRT in previous history of radiation therapy to the same area.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial tests a combination of precise radiation therapy and a hormone-blocking drug in prostate cancer patients with limited spread. It aims to control the disease and delay more toxic treatments. The approach targets small areas of cancer spread and blocks the cancer's growth signals. The hormone-blocking drug is a novel treatment approved for specific prostate cancer cases.

Who is the study for?
Men with advanced prostate cancer that hasn't spread widely (≤5 sites, ≤4 in one organ excluding the brain) and is resistant to hormone therapy but has not metastasized according to standard scans. Participants must have a good performance status, be able to take oral medication, and have no recent other cancers or severe diseases. They should not have had certain previous treatments for prostate cancer.
What is being tested?
The trial tests if adding SBRT (a type of precise radiation therapy) to Darolutamide (a drug blocking male hormones that can fuel prostate cancer growth) can delay the need for more aggressive therapies in men whose prostate cancer is progressing despite treatment but hasn't spread extensively.
What are the potential side effects?
Possible side effects include fatigue, skin reactions from radiation, gastrointestinal issues like nausea or diarrhea from Darolutamide, as well as potential liver function changes and blood count alterations due to the medications used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer is confirmed and does not have certain aggressive features.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have more than 5 cancer spread sites or had radiation in the same area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Radiographic Progression-free Survival
Secondary study objectives
Disease Specific Survival
Functional Assessment of Cancer Therapy-Prostate
Local Control
+7 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Darolutamide (BAY1841788)+ SBRTExperimental Treatment2 Interventions
CRPC subjects will receive LHRH agonist in combination with the new generation of hormonal therapy Darolutamide (300mg). Subjects who progress on LHRH + Darolutamide and develop oligometastases will receive SBRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darolutamide
FDA approved
SBRT
2014
Completed Phase 2
~1060

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 often target the androgen receptor pathway, crucial for cancer cell growth. Androgen deprivation therapy (ADT) reduces androgen levels, slowing cancer progression. Androgen receptor inhibitors like darolutamide block androgen receptors, preventing cancer cells from using androgens. Precise high-dose radiation therapy (SBRT) targets and destroys cancer cells with minimal damage to surrounding tissues. These mechanisms are vital as they offer targeted approaches to control and potentially eradicate prostate cancer, improving patient outcomes.

Find a Location

Who is running the clinical trial?

Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
58 Previous Clinical Trials
21,150 Total Patients Enrolled
9 Trials studying Prostate Cancer
2,639 Patients Enrolled for Prostate Cancer
Tamim Niazi, MDPrincipal InvestigatorJewish General Hospital
7 Previous Clinical Trials
1,221 Total Patients Enrolled
4 Trials studying Prostate Cancer
945 Patients Enrolled for Prostate Cancer

Media Library

Darolutamide (BAY1841788) (Androgen Receptor Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04070209 — Phase 2
Prostate Cancer Research Study Groups: Darolutamide (BAY1841788)+ SBRT
Prostate Cancer Clinical Trial 2023: Darolutamide (BAY1841788) Highlights & Side Effects. Trial Name: NCT04070209 — Phase 2
Darolutamide (BAY1841788) (Androgen Receptor Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04070209 — Phase 2
~28 spots leftby Nov 2027
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