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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)
≤ 5 metastatic sites (on conventional imaging); ≤ 4 tumors within any given organ system, excluding brain (e.g. up to 4 bone metastases, or 4 lung metastases); All sites of disease must be amenable to SBRT with no history of the metastases being irradiated (radiation exposure prior to the development of the metastases is permitted as long as the radiation exposure was not intended for the metastases. For example, if there is prior pelvic radiation to the prostate and a subsequent iliac metastasis develops within the previously irradiated pelvic radiation field, then the iliac metastasis would be eligible per the institution policy and practice); In the case of a suspicious lesion in an unusual location such as lung or thoracic lymph nodes (without other abdominal lymph nodes), a confirmatory imaging or biopsy is strongly recommended
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing whether a new combination therapy of SBRT and Darolutamide can help improve progression-free survival in men with metastatic prostate cancer who have not yet received systemic therapy.

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.Check my eligibility
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.See study design
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...
I have 5 or fewer cancer spread sites, and none have been treated with radiation.
Select...
My prostate cancer is confirmed and does not have certain aggressive features.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiographic Progression-free Survival
Secondary outcome measures
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%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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

Find a Location

Who is running the clinical trial?

Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
55 Previous Clinical Trials
21,094 Total Patients Enrolled
15 Trials studying Prostate Cancer
3,679 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this trial at present?

"Affirmative. According to the information held on clinicaltrials.gov, this medical trial is actively engaging patients in recruitment; it was initially posted on October 19th 2020 and most recently revised on September 20th 2021. Sixty-six individuals are needed for enrolment across 1 centre."

Answered by AI

Are there any other experiments that have utilized stereotactic body radiotherapy (SBRT)?

"Currently, 24 investigations are running into the effectiveness of Stereotactic Body Radiation Therapy (SBRT). Of those studies 9 have progressed to Phase 3. Although Toronto is a major research hub for SBRT, there exists over 1400 active trial locations around the world."

Answered by AI

What is the cap for participants in this experiment?

"Affirmative, according to the clinicaltrials.gov portal this medical trial commenced recruitment on October 19th 2020 and was last updated in September 2021; with 66 patients needed across 1 site."

Answered by AI

Is this research protocol an innovative approach to treating the condition?

"Presently, 24 clinical trials for stereotactic body radiation therapy are live in 557 cities and 44 countries. The initial study began in 2016 through the sponsorship of Orion Corporation, involving 1,303 participants who reached Phase 3 drug approval stage before its completion. Since then, 30 additional experiments have been concluded."

Answered by AI

Has the U.S. Food and Drug Administration authorized SBRT for medical use?

"The safety of SBRT was evaluated as a 2 based on the existing evidence in Phase 2 trials, which indicate some affirmation for its security but lack data to verify efficacy."

Answered by AI
~34 spots leftby Nov 2027