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Radiation Therapy

Reduced margin for Prostate Cancer (PROTRACT Trial)

N/A
Waitlist Available
Led By Beibei Zhang, PhD
Research Sponsored by Southlake Regional Health Centre
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 6 months
Awards & highlights
No Placebo-Only Group

Summary

The objectives of this study are: 1. Retrospectively validate a reduced margin schema for intermediate risk prostate hypofractionated VMAT treatments 2. Demonstrate in a prospective pilot clinical trial that patients planned and treated with the reduced margin schema will have reduced acute rectal toxicity

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduced acute rectal toxicity from reduced PTV margin

Side effects data

From 2020 Phase 2 & 3 trial • 399 Patients • NCT00922974
32%
Fatigue
31%
Back pain
21%
Nausea
20%
Hemoglobin decreased
16%
Constipation
16%
Dyspnea
16%
Hyperglycemia
15%
Hypoalbuminemia
15%
Hypocalcemia
14%
Anorexia
14%
Abdominal pain
12%
Leukopenia
12%
Pain in extremity
12%
Platelet count decreased
12%
Alkaline phosphatase increased
12%
Muscle weakness
11%
Vomiting
11%
Diarrhea
11%
Edema limbs
10%
Lymphopenia
10%
Aspartate aminotransferase increased
9%
Hypokalemia
9%
Hyponatremia
9%
Peripheral sensory neuropathy
9%
Alanine aminotransferase increased
9%
Cough
8%
Joint pain
8%
Pain [other]
7%
Dizziness
7%
Thrombosis
7%
Fever
7%
Weight loss
7%
Neck pain
7%
Hypotension
6%
Muscle weakness lower limb
6%
Musculoskeletal disorder
6%
Urogenital disorder
6%
Headache
6%
Anxiety
6%
Chest pain
6%
Pain [NOS]
6%
Dehydration
5%
Hypoxia
5%
Hyperbilirubinemia
5%
Pleural effusion
5%
Confusion
5%
Fracture
5%
Creatinine increased
4%
Bone pain
4%
Dysphagia
3%
General symptom
3%
Rash desquamating
2%
Peripheral motor neuropathy
1%
Soft tissue infection [with unknown ANC]
1%
Respiratory disorder
1%
Hypercalcemia
1%
Pneumonia [with unknown ANC]
1%
Neutrophil count decreased
1%
Lower gastrointestinal hemorrhage
1%
Duodenal ulcer
1%
Oral pain
1%
Mucositis oral
1%
Blood disorder
1%
Chills
1%
Disease progression
1%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Radiosurgery/SBRT (Phase III)
External Beam Radiation Therapy
Radiosurgery/SBRT (Phase II)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Reduced marginExperimental Treatment1 Intervention
Patient cohort planned with the reduced margin validated from the retrospective study
Group II: Standard marginActive Control1 Intervention
Patient cohort planned with the current standard PTV margin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External beam radiation therapy
2009
Completed Phase 3
~520

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreOTHER
674 Previous Clinical Trials
1,565,805 Total Patients Enrolled
31 Trials studying Prostate Cancer
12,031 Patients Enrolled for Prostate Cancer
Southlake Regional Health CentreLead Sponsor
17 Previous Clinical Trials
5,638 Total Patients Enrolled
1 Trials studying Prostate Cancer
38 Patients Enrolled for Prostate Cancer
University Health Network, TorontoOTHER
1,520 Previous Clinical Trials
503,194 Total Patients Enrolled
65 Trials studying Prostate Cancer
15,542 Patients Enrolled for Prostate Cancer
~8 spots leftby Nov 2025
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