← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

PCS IX Trial 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.Check my eligibility

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.See study design

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.

PCS IX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My condition is worsening despite treatment.

Select...

I have not had chemotherapy for prostate cancer.

Select...

I am mostly active and can care for myself.

Select...

I can swallow pills whole and follow the study's requirements.

Select...

My prostate cancer is confirmed and does not have certain aggressive features.

Select...

I am currently on hormone therapy for cancer or have had surgery to remove my testicles.

PCS IX Trial 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

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

Local Control

Overall Survival

PSA response

+8 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

79%

Cough

64%

Dyspnea

64%

Nausea

57%

Fatigue

43%

Constipation

36%

Pain

36%

Dizziness

29%

Anemia

29%

Back pain

29%

Vomiting

21%

Anorexia

21%

Chest pain

21%

Lymphocyte count decreased

21%

Death NOS

21%

Anxiety

21%

Fall

14%

Wheezing

14%

Dysphagia

14%

Hypotension

14%

Depression

14%

Diarrhea

14%

Platelet count decreased

14%

Abdominal Pain

14%

Edema

14%

Fever

14%

Headache

14%

Insomnia

14%

Palpitations

Alopecia

Dehydration

Blurred vision

Sinusitis

Otitis externa

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Creatinine increased

Dementia

Productive cough

Pneumonitis

Dysuria

White blood cell count decreased

Throat pain

Bone marrow biopsy

Hearing impaired

Rash

Hypernatremia

Eye pain

Hypertension

Tachycardia

Lung infection

Neuropathy

Pleuritic pain

Neutropenia

Hypoxia

Aspiration pneumonia

Blood bilirubin increased

Muscle weakness

Tremor

Weight loss

Thrombocytopenia

Floaters

Toothache

Esophagitis

Leukocytosis

Edema limbs

Gait disturbance

Parathesia (tingling)

Edema face

COPD

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Body Radiation Therapy

Maintenance Chemotherapy

PCS IX 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

Leuprolide

FDA approved

Goserelin

FDA approved

Triptorelin

FDA approved

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

Enzalutamide

FDA approved

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor

55 Previous Clinical Trials

21,030 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

1,157 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

Frequently Asked Questions

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

How many individuals are enrolled in this clinical trial?

"In order to move forward with this research, 130 individuals that fulfill the pre-determined conditions must agree to participate. This can be done from multiple locations, such as CancerCare Manitoba in Winnipeg or BC CANCER Vancouver in Vancouver."

Answered by AI

What type of cancer does Stereotactic Body Radiation Therapy usually help improve?

"Stereotactic Body Radiation Therapy can be used as a treatment for breast cancer, radiation therapy side effects, and endometrial thinning."

Answered by AI

What is the general efficacy of Stereotactic Body Radiation Therapy?

"Stereotactic Body Radiation Therapy was first investigated in 2000 at Centre de Recherche Clinique du CHUS. Since that time, there have been a total of 357 completed clinical trials. As of now, 213 different studies are still ongoing; many of these taking place in Winnipeg, Manitoba."

Answered by AI

Can patients still sign up for this experiment?

"That is correct. The clinical trial detailed on clinicaltrials.gov is recruiting patients as we speak. This specific study was posted on October 1st, 2016 and was edited for the last time on October 19th, 2020. In total, 130 people are needed for the 11 different locations associated with this project."

Answered by AI

Has this particular type of trial been conducted before?

"Stereotactic Body Radiation Therapy has been researched since the year 2000. The first study was funded by AstraZeneca and published in that same year. After this initial success, Stereotactic Body Radiation Therapy received drug approval for Phase 3 clinical trials. In total, there are 213 different ongoing studies involving this treatment across 2248 cities and 63 countries."

Answered by AI

across how many different sites is this clinical trial being conducted?

"There are 11 trial sites for this clinical study, which is based out of CancerCare Manitoba in Winnipeg, MB; BC CANCER Vancouver in Vancouver, BC; and London Regional Cancer Program - London Health Sciences Centre in London, ON."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Management of Castration-Resistant Prostate Cancer With Oligometastases

Dr. Tamim Niazi 2016. "Management of Castration-Resistant Prostate Cancer With Oligometastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02685397.

All > Bone Metastases