Tumor-Targeted Radiotherapy for Localized Prostate Cancer
This study aims to determine the rates of local control after standard targeted boost radiotherapy in patients with localized prostate cancer.
Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy
+ No Active Treatment - completed Prior Radiation
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.85 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
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