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Hormone Therapy

Hormone Therapy + SBRT + Enzalutamide for Prostate Cancer (PCS IX Trial)

Phase 2 & 3
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
Progressive disease at study entry as defined by specific criteria
No prior cytotoxic chemotherapy for prostate cancer
Must not have
Radiation or radionuclide therapy for treatment of metastasis
Radiation therapy for treatment of the primary tumour within 3 weeks of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is designed to test whether eradicating oligometastases (a small number of cancerous cells that have spread from the original tumor) with SBRT (a type of radiation therapy) can delay disease progression and postpone second-line systemic therapies in patients with castration-resistant prostate cancer.

Who is the study for?
Men aged 18+ with castration-resistant prostate cancer and oligometastatic recurrence, who are on or will continue androgen deprivation therapy. They must have a low testosterone level, up to 5 metastases amenable to SBRT, no prior chemotherapy for prostate cancer, an ECOG performance status of 0-2 or Karnofsky >70%, and agree to use contraception. Exclusions include severe cardiovascular conditions, recent seizures or strokes, certain blood pressure levels, absorption disorders, recent major surgery or opiate analgesic use.
What is being tested?
This trial is testing whether adding Stereotactic Body Radiation Therapy (SBRT) to the standard care (LHRH agonist plus Enzalutamide) can delay disease progression in men with oligometastatic castration-resistant prostate cancer. Participants will be randomly assigned to receive either the standard treatment alone or combined with SBRT.
What are the potential side effects?
Possible side effects include hot flashes from hormone therapy; fatigue; skin reactions at radiation sites; gastrointestinal symptoms like nausea; potential urinary issues due to radiation; increased risk of fractures if bone metastases are present.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is worsening despite treatment.
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I have not had chemotherapy for prostate cancer.
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I am mostly active and can care for myself.
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I can swallow pills whole and follow the study's requirements.
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My prostate cancer is confirmed and does not have certain aggressive features.
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I am currently on hormone therapy for cancer or have had surgery to remove my testicles.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received radiation therapy for cancer spread.
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I received radiation for my main cancer less than 3 weeks ago.
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My primary disease has not been treated.
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I have brain metastasis or active leptomeningeal disease.
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I have not had major surgery in the last 4 weeks.
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I have a digestive condition that affects how my body absorbs food.
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I am currently using herbal products or systemic corticosteroids.

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
Local Control
Overall Survival
PSA response
+8 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
87%
Fatigue
53%
Nausea
33%
Cough
27%
Pain
27%
Fall
27%
Dyspnea
27%
Depression
27%
Lymphocyte count decreased
27%
Platelet count decreased
27%
Anemia
20%
Dizziness
20%
Chills
20%
Edema limbs
20%
Chest pain
20%
Neutropenia
20%
Diarrhea
13%
Dysesthesia
13%
Edema
13%
Insomnia
13%
Constipation
13%
Delirium
13%
Dysgeusia
13%
Myalgia
13%
Skin infection
13%
Vomiting
13%
Tinnitus
13%
Rash
13%
Back pain
13%
Weakness (limb)
13%
Weight loss
7%
Bruising
7%
Hearing loss
7%
Anxiety
7%
Headaches
7%
Oral lesions
7%
Weakness (facial)
7%
Neutrophil count decreased
7%
Acute kidney injury
7%
Hypokalemia
7%
Lymphocytopenia
7%
Seizures
7%
Hearing impaired
7%
Hypernatremia
7%
Creatinine increased
7%
Headache
7%
Death NOS
7%
Gait disturbance
7%
Nasal congestion
7%
Fever
7%
Tremor
7%
Urinary urgency
7%
Hypoxic respiratory failure
7%
Amnesia
7%
Photophobia
7%
Pleural effusion
7%
Urinary frequency
7%
Dysphagia
7%
Low white blood count
7%
Sneezing
7%
Cognitive disturbance
7%
Erythema multitforme
7%
Lung infection
7%
Hypertension
7%
Allergy (seasonal)
7%
Muscle weakness
7%
Proteinuria
7%
Hypomagnesemia
7%
Parathesia (tingling)
7%
Febrile Neutropenia
7%
Anorexia
7%
Sleep apnea
7%
Encephalopathy
7%
Hypoxia
7%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy

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.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LHRH agonist + Enzalutamide + SBRTExperimental Treatment5 Interventions
Subjects will receive LHRH agonist in combination with the new generation of hormone therapy (enzalutamide, 40mg) plus the additional SBRT treatment
Group II: LHRH agonist + EnzalutamideActive Control4 Interventions
Subjects will receive LHRH agonist in combination with the new generation of hormonal therapy (enzalutamide, 40mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triptorelin
FDA approved
Enzalutamide
FDA approved
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
Goserelin
FDA approved
Leuprolide
FDA approved

Find a Location

Who is running the clinical trial?

Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
58 Previous Clinical Trials
21,086 Total Patients Enrolled
17 Trials studying Prostate Cancer
3,699 Patients Enrolled for Prostate Cancer
Tamim Niazi, MDPrincipal InvestigatorJewish General Hospital
7 Previous Clinical Trials
1,157 Total Patients Enrolled
4 Trials studying Prostate Cancer
945 Patients Enrolled for Prostate Cancer

Media Library

Enzalutamide (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02685397 — Phase 2 & 3
Prostate Cancer Research Study Groups: LHRH agonist + Enzalutamide, LHRH agonist + Enzalutamide + SBRT
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT02685397 — Phase 2 & 3
Enzalutamide (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02685397 — Phase 2 & 3
~5 spots leftby Apr 2025
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