What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as SBRT and Darolutamide, have specific side effects. SBRT often leads to fatigue, urinary issues (including frequency and urgency), and rectal irritation. Darolutamide, an androgen receptor inhibitor, generally has fewer central nervous system side effects but can still cause fatigue, pain in extremities, and rash. These side effects are important to consider when discussing treatment options with your doctor.

What prior FDA approvals exist?

The FDA has approved several androgen receptor inhibitors for the treatment of prostate cancer, including enzalutamide, apalutamide, and darolutamide. These drugs work by blocking the androgen receptor signaling pathway, which is crucial for the growth of prostate cancer cells. Enzalutamide and apalutamide have been approved for both metastatic and nonmetastatic castration-resistant prostate cancer (CRPC). Darolutamide, with its distinct structure and potentially fewer side effects, has also been approved for nonmetastatic CRPC. Additionally, precise high-dose radiation therapies, such as stereotactic body radiation therapy (SBRT), are used to target and treat localized prostate cancer with high precision.

What other types of research exist?

Promising novel alternatives for prostate cancer treatment in 2024 include: <ol> <li>Combination of Abiraterone and Olaparib: This combination has shown improved radiographic progression-free survival in patients with homologous recombination repair (HRR) deficiencies.</li> <li>Enzalutamide: When combined with androgen deprivation therapy (ADT), enzalutamide has demonstrated improved survival outcomes in metastatic hormone-sensitive prostate cancer.</li> <li>Platinum-based Chemotherapy: Particularly for patients with HRR gene alterations, platinum-based chemotherapy is a reasonable option due to its efficacy in HRR-deficient cells.</li> <li>Bipolar Androgen Therapy (BAT): BAT has shown potential in restoring sensitivity to androgen receptor-targeting therapies like abiraterone and enzalutamide in castration-resistant prostate cancer (CRPC).</li> </ol>

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Diarrhea

Anemia

Shortness of Breath

Abdominal pain

Kidney Injury and/or Infection

Pneumonia

Weight Loss

Dyspnea

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Atrial fibrillation with rapid ventricular response

Pleural effusion

colitis

Thrombocytopenia

Respiratory failure

Skin rash

100%

80%

60%

40%

20%

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

0 / 3Eligibility criteria met

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.