Completed

Tumor-Targeted Radiotherapy for Localized Prostate Cancer

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Study Aim

This study aims to determine the rates of local control after standard targeted boost radiotherapy in patients with localized prostate cancer.

What is being tested

Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy

+ No Active Treatment - completed Prior Radiation

RadiationOther
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorUniversity Health Network, Toronto
Last updated: June 22, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 23, 2012

Actual date on which the first participant was enrolled.

This is a prospective two arm phase 2 trial investigating the technical and clinical performance of tumor-targeted (rather than prostate targeted) radiotherapy. Cohort 1 (Control group): This group consists of patients who have had previous radiation. This group will not receive any active treatment but will have a biopsy at 3 years from the time they completed their radiation therapy. Patient in this group will also continue to have their PSA checked per standard practice Cohort 2 (Experimental group): Patients in this group will receive one of 2 treatment arms of their choice. In addition to the MRI-guided prostate biopsy at 3 years and regular standard of care PSA checks, this group will also complete a quality of life questionnaire and have regular imaging per standard practice. Both groups will be followed by the research team per protocol.

Principal SponsorUniversity Health Network, Toronto
Last updated: June 22, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

85 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms

Criteria

Inclusion Criteria \[applicable to both Cohorts 1 (control) and Cohort 2 (Experimental) unless otherwise specified\]: 1. Histological evidence of prostate adenocarcinoma. 2. Discrete intra-prostatic tumor that can be confidently visualized on MRI prior to radiotherapy (\>5mm maximum diameter but \<33% of prostate volume, biopsy confirmed from initial diagnosis or interventional Biopsy) ) 3. At least 18 years old 4. ECOG performance status 0 or 1 5. Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed (this does not include standard care laboratory tests or imaging studies). 6. Patients will be one of the following risk groups prior to therapy: * Low-risk disease (Gleason 6 and PSA \<10 and T1) AND \>50% of biopsy cores involved with tumor * Intermediate-risk disease (Gleason 7 or PSA 10-20 or T2) * High-risk disease (Gleason \>8 or T3 or PSA \>20) 7. Risk of LN involvement \<30% (Roach formula = 2/3PSA(\[G-6\]x10)) 8. Patients who received 78Gy RT to the prostate gland 3-4.5 years prior to enrollment (Cohort 1 only) Exclusion Criteria \[applicable to both Cohorts 1 (control) and Cohort 2(Experimental) unless otherwise specified\]: 1. Previous history of radiation therapy to the prostate (Cohort 2) 2. Diagnosis of another cancer not being skin cancer within the last 5 years (Cohort 2) 3. Patients weight as per MRI Technologist's discretion 4. Patients with contraindications to MRI: this includes patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI determination. Exceptions will be allowed if deemed sage and appropriate by the MRI technologist. 5. Severe claustrophobia 6. Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding biopsy 7. Current hormonal therapy (Cohort 1) or initiated \>2 weeks prior to enrollment (Cohort 2) 8. Radiological evidence of regional or distant metastases (Cohort 2) 9. Other urinary or medical conditions deemed by the PI or associates to make the patient ineligible for MRI-guided prostate biopsy 10. Contraindications to the endorectal coil, surgically absent rectum, severe hemorrhoids or previous colorectal surgery 11. Contraindications to conscious sedation 12. Latex allergy 13. History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE (Cohort 2) 14. Other medical conditions deemed by the PI to make patient ineligible for study intervention

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Patients who received 78Gy RT to the prostate gland 3-4.5 years prior to enrollment. This group will not be receiving any active treatment

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Health Network, The Princess Margaret

Toronto, CanadaOpen University Health Network, The Princess Margaret in Google Maps
CompletedOne Study Center