Prostate Boost Irradiation With Stereotactic Body RT (SBRT)
PBS
A Randomized Phase II Trial Investigating Stereotactic Body RadioTherapy (SBRT) for Prostate Boost Irradiation in the Treatment of High Risk Prostate Cancer (PrCa)
1 other identifier
interventional
100
1 country
2
Brief Summary
A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) boost to prostate or conventional radiotherapy boost to prostate in 1:1 ratio. Prostate radiotherapy boost will be administered after standard pelvic radiotherapy. Subjects will be followed for 24 months post radiation treatment for Quality of Life assessment and toxicity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Jan 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2017
CompletedFirst Posted
Study publicly available on registry
December 21, 2017
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedJune 4, 2020
June 1, 2020
3 years
December 13, 2017
June 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Short Term Quality of Life (QoL)
To compare early QoL (up to 6 months post RT) in patients with high risk adenocarcinoma of the prostate treated with ADT and RT in the form of pelvic nodal irradiation and prostate boost with standard fractionation, or pelvic nodal irradiation and prostate boost with SBRT using Cyberknife or VMAT. QoL, defined as bowel and bladder function and bother after PrCa treatment, will be measured prior to and at regular intervals after completion of radiotherapy using the established Prostate QoL (The Expanded Prostate cancer Index Composite (EPIC-26 instrument)). Higher EPIC score represent a better outcome
up to 6 months post radiation
Secondary Outcomes (3)
Long Term Quality of Life (QoL)
24 months
Urinary function assessment
24 months
Late Toxicity
12-24 months
Study Arms (2)
Arm 1
ACTIVE COMPARATORConventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist
Arm 2
EXPERIMENTALStereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist
Interventions
SBRT: 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days)
CRT: 33 - 35 Gy in 16 fractions (5 days per week - over 22 days)
Eligibility Criteria
You may qualify if:
- Histological and or clinical diagnosis of high risk adenocarcinoma of the prostate within six months of entry (stage T3 or higher and/or Gleason score 8 or higher and/or initial PSA level above 20;)
- No radiographic evidence of metastatic disease to the abdomen, lymph nodes, bone or other distant organs; determined by standard staging investigations (bone scan and CT-scan of the abdomen and pelvis) or incidental findings (localized N0, M0 disease)
- Patient is able to complete the quality of life questionnaires in English.
- Informed consent obtained
You may not qualify if:
- Histological diagnosis of carcinoma of the prostate more than six months prior to potential registration date;
- Previous treatment for carcinoma of the prostate (other than biopsy or TURP), including bilateral orchiectomy;
- Patients previously on more than twelve weeks of hormone therapy for their PrCa;
- Past history of other malignancies except: adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for more than 3 years;
- Contraindications to placement of gold seeds for daily prostate localization;
- Previous pelvic RT and/or significant pelvic surgery;
- Severe diverticular or inflammatory bowel disease (as determined by the treated radiation oncologist)
- Previous hip replacement
- PSA over 50
- IPSS 20 or higher
- TRUS-based prostate
- volume of \> 80 cc
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Juravinski Cancer Centerlead
- Sanoficollaborator
Study Sites (2)
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Walker Family Cancer Centre ,Niagara Health - St. Catharines Site
St. Catharines, Ontario, Canada
Related Publications (1)
Gouveia A, Mesci A, Isfahanian N, Dayes I, Quan K, Goldberg M, Schnarr KL, Lukka H, Cuthbert D, Hallock A, Douvi G, Wright J, Swaminath A, Chow T, Diamond K, Hajdok G, Maharaj L, Ewusie J, Tsakiridis T. Primary Analysis of (NCT03380806) a Phase II Randomized Trial of Stereotactic Body Radiotherapy Boost Versus Conventional Fractionation External Beam Radiotherapy Boost in Unfavorable-Intermediate and High-Risk Prostate Cancer. Prostate. 2025 Jul;85(10):977-985. doi: 10.1002/pros.24905. Epub 2025 Apr 27.
PMID: 40287937DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Theos Tsakiridis, Senior Principle Investigator, MD, FRCPC
CONTACT
Naghmeh Isfahanian, Junior Principle Investigator, MD, FRCPC
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Term Professional staff
Study Record Dates
First Submitted
December 13, 2017
First Posted
December 21, 2017
Study Start
January 1, 2019
Primary Completion
January 1, 2022
Study Completion
January 1, 2022
Last Updated
June 4, 2020
Record last verified: 2020-06