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Hormone Therapy

Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer (PBS Trial)

Phase 2
Waitlist Available
Research Sponsored by Juravinski Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-24 months
Awards & highlights

PBS Trial Summary

This trial is testing a new way to give radiation to prostate cancer patients who are at high risk. Half of the patients will get the new treatment and half will get the standard treatment. Researchers will follow the patients for 24 months to see how well they do.

Eligible Conditions
  • Prostate Cancer

PBS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Short Term Quality of Life (QoL)
Secondary outcome measures
Late Toxicity
Long Term Quality of Life (QoL)
Urinary function assessment

Side effects data

From 2022 Phase 3 trial • 27 Patients • NCT01926197
100%
Fatigue
100%
Aspartate aminotransferase increased
92%
Diarrhea
92%
Platelet count decreased
83%
Anemia
83%
Weight loss
83%
Alkaline phosphatase increased
83%
Nausea
75%
Pain, abdominal
67%
Decreased appetite (anorexia)
67%
Hypertension
58%
Hyperglycemia
58%
Nerve damage or injury (neuropathy)
58%
Hypokalemia
50%
Alanine aminotransferase increased
50%
White blood cell decreased
50%
Hypoalbuminemia
42%
White blood cell (WBC) count elevated (leukocytosis)
42%
Lymphocyte count decreased
33%
Bloating
33%
Edema, peripheral
25%
Vomiting
25%
Bad taste in mouth (dysgeusia)
25%
Hyponatremia
25%
Anxiety
25%
Pain
25%
Constipation
25%
Hypocalcemia
25%
Labored breathing (dyspnea)
17%
Muscle pain (myalgia)
17%
Indigestion (dyspepsia)
17%
Pain, back
17%
Flatulence
17%
General feeling of discomfort (malaise)
17%
Depression
17%
Hair loss, immune-realted (alopecia)
17%
Neutrophil count decreased
17%
Difficulty sleeping (insomnia)
17%
Oral inflammation (mucositis)
8%
Pain, flank
8%
Other, Creatinine decreased
8%
Lymphedema
8%
Hearing impaired
8%
Bleed (hemorrhage), gastrointestinal
8%
Edema, localized
8%
Thromboembolic event
8%
Allergic reaction
8%
Chills
8%
Fever
8%
Drowsiness, unusual (somnolence)
8%
Tiredness (fatigue)
8%
Muscle weakness lower limb
8%
Abdominal distention
8%
Abnormal sensation in the mouth (oral dysesthesia)
8%
Dry mouth
8%
Gastroesophageal reflux disease
8%
Pain, stomach
8%
Pain, chest, non-cardiac
8%
Lymphocyte count increased
8%
Other, Neutrophil count increase
8%
Other, Protein total decrease
8%
Thrombocytopenia
8%
Weight gain
8%
Hypercalcemia
8%
Hypernatremia
8%
Dizziness
8%
Nerve tingling (paresthesia)
8%
Slow or slurred speech (dysarthria)
8%
Tremor
8%
Rash
8%
Gastroparesis
8%
Flu-like symptoms
8%
Alkaline phosphatase decreased
8%
Blood bilirubin increased
8%
Dehydration
8%
Nerve damage or injury (neuropathy), peripheral sensory
8%
Confusion
8%
Other, axilla boil
8%
Other, hemoglobin decreased
8%
Infusion-related reaction
8%
Arthritis
8%
Generalized muscle weakness
8%
Memory impairment
8%
Movements involuntary
8%
Chronic kidney disease
8%
Cataract
8%
Other, excess in the stool (steatorrhea)
8%
Other, stool discolored, clay color
8%
Gamma-glutamyl transferase (GGT) increased
8%
Hypoglycemia
8%
Urinary incontinence
8%
Urinary urgency
8%
Urine discoloration
8%
Excessive sweating (hyperhidrosis)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Modified FOLFIRINOX
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy

PBS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2Experimental Treatment3 Interventions
Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist
Group II: Arm 1Active Control3 Interventions
Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leuprolide
FDA approved
Pelvic Radiation
2001
Completed Phase 2
~30
Stereotactic Body Radiotherapy (SBRT)
2016
Completed Phase 3
~580

Find a Location

Who is running the clinical trial?

Juravinski Cancer CenterLead Sponsor
12 Previous Clinical Trials
2,209 Total Patients Enrolled
1 Trials studying Prostate Cancer
21 Patients Enrolled for Prostate Cancer
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,880 Total Patients Enrolled
47 Trials studying Prostate Cancer
6,341 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Prostate Boost Irradiation With Stereotactic Body RT (SBRT)
Naghmeh Isfahanian 2019. "Prostate Boost Irradiation With Stereotactic Body RT (SBRT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03380806.
All > Sbrt
~16 spots leftby Apr 2025
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