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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

PROTRACT Trial Summary

The objectives of this study are: Retrospectively validate a reduced margin schema for intermediate risk prostate hypofractionated VMAT treatments 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

PROTRACT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Pain in extremity
12%
Leukopenia
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%
Peripheral sensory neuropathy
9%
Hypokalemia
9%
Hyponatremia
9%
Alanine aminotransferase increased
9%
Cough
8%
Joint pain
8%
Pain [other]
7%
Neck pain
7%
Dizziness
7%
Thrombosis
7%
Weight loss
7%
Fever
7%
Hypotension
6%
Musculoskeletal disorder
6%
Muscle weakness lower limb
6%
Urogenital disorder
6%
Headache
6%
Anxiety
6%
Chest pain
6%
Pain [NOS]
6%
Dehydration
5%
Hypoxia
5%
Pleural effusion
5%
Hyperbilirubinemia
5%
Confusion
5%
Fracture
5%
Creatinine increased
4%
Bone pain
4%
Dysphagia
3%
General symptom
3%
Rash desquamating
2%
Peripheral motor neuropathy
1%
Hypercalcemia
1%
Pneumonia [with unknown ANC]
1%
Neutrophil count decreased
1%
Respiratory disorder
1%
Lower gastrointestinal hemorrhage
1%
Duodenal ulcer
1%
Oral pain
1%
Soft tissue infection [with unknown ANC]
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)

PROTRACT 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
656 Previous Clinical Trials
1,551,257 Total Patients Enrolled
34 Trials studying Prostate Cancer
12,588 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
1,476 Previous Clinical Trials
485,130 Total Patients Enrolled
63 Trials studying Prostate Cancer
15,350 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
Journal of Clinical OncologyJournal
Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer
Catton, Charles N., Himu Lukka, Chu-Shu Gu, Jarad M. Martin, Stéphane Supiot, Peter W.M. Chung, Glenn S. Bauman, et al.. 2017. “Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2016.71.7397.
The Lancet OncologyJournal
Conventional Versus Hypofractionated High-dose Intensity-modulated Radiotherapy for Prostate Cancer: 5-year Outcomes of the Randomised, Non-inferiority, Phase 3 Chhip Trial
Dearnaley, David, Isabel Syndikus, Helen Mossop, Vincent Khoo, Alison Birtle, David Bloomfield, John Graham, et al.. 2016. “Conventional Versus Hypofractionated High-dose Intensity-modulated Radiotherapy for Prostate Cancer: 5-year Outcomes of the Randomised, Non-inferiority, Phase 3 Chhip Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(16)30102-4.
Journal of UrologyJournal
Expanded Prostate Cancer Index Composite for Clinical Practice: Development and Validation of a Practical Health Related Quality of Life Instrument for Use in the Routine Clinical Care of Patients with Prostate Cancer
Chang, Peter, Konrad M. Szymanski, Rodney L. Dunn, Jonathan J. Chipman, Mark S. Litwin, Paul L. Nguyen, Christopher J. Sweeney, et al.. 2011. “Expanded Prostate Cancer Index Composite for Clinical Practice: Development and Validation of a Practical Health Related Quality of Life Instrument for Use in the Routine Clinical Care of Patients with Prostate Cancer”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2011.04.085.
clinicaltrials.govStudy
Prostate Margin Reduction to Reduce Acute Rectal Toxicity (PROTRACT)
Beibei Zhang 2019. "Prostate Margin Reduction to Reduce Acute Rectal Toxicity (PROTRACT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04004858.
All > Toxicity
~9 spots leftby May 2025
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