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Prostate Boost Irradiation With Stereotactic Body RT (SBRT) (PBS)

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
LHRH agonist
Pelvic Radiation
Stereotactic Body Radiotherapy (SBRT)
Conventional Radiotherapy (CRT) Prostate Boost
Sponsored by
Juravinski Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stereotactic body radiotherapy (SBRT), conventional radiotherapy (CRT), High risk prostate cancer, quality of life (QoL), The Expanded Prostate cancer Index Composite (EPIC-26), International Prostate Symptom Score (IPSS)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • • 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

Sites / Locations

  • Juravinski Cancer CentreRecruiting
  • Walker Family Cancer Centre ,Niagara Health - St. Catharines SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist

Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Long Term Quality of Life (QoL)
long term QoL QoL, defined as bowel and bladder function and bother after PrCa treatment, will be measured prior to and at regular intervals up to 24 months month 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
Urinary function assessment
short and long term quality of urinary function (The International Prostate Symptom Score (IPSS)). Total IPSS is between 1-35 / lower score shows better function.
Late Toxicity
Grade 2-4 treatment related late (12-24 months), bladder and bowel related toxicity evaluated by the Expanded Common Toxicity Criteria of the National Cancer Institute of Canada (NCI)

Full Information

First Posted
December 13, 2017
Last Updated
June 2, 2020
Sponsor
Juravinski Cancer Center
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03380806
Brief Title
Prostate Boost Irradiation With Stereotactic Body RT (SBRT)
Acronym
PBS
Official Title
A Randomized Phase II Trial Investigating Stereotactic Body RadioTherapy (SBRT) for Prostate Boost Irradiation in the Treatment of High Risk Prostate Cancer (PrCa)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Juravinski Cancer Center
Collaborators
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
In this study we investigate stereotactic body radiotherapy (SBRT) as a boost radiotherapy treatment, following pelvic radiotherapy, in patients with high risk prostate cancer (PrCa) treated with Androgen Deprivation Therapy (ADT). One hundred patients with localized high risk PrCa will receive ADT for a total of 3 years. Three months after initiation of ADT all patients will receive pelvic (lymph node and prostate) treatment of 45Gy in 25 fractions (5 days per week). Then patients will be randomized to receive either The conventional radiotherapy (CRT) of 33 - 35 Gy in 16 fractions (5 days per week - over 22 days) (comparator arm) or SBRT boost treatment of 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days) (experimental arm). SBRT boost treatment will be delivered with either cyberknife or VMAT technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stereotactic body radiotherapy (SBRT), conventional radiotherapy (CRT), High risk prostate cancer, quality of life (QoL), The Expanded Prostate cancer Index Composite (EPIC-26), International Prostate Symptom Score (IPSS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist
Intervention Type
Drug
Intervention Name(s)
LHRH agonist
Other Intervention Name(s)
Eligard
Intervention Description
Standard LHRH agonist for 3 years
Intervention Type
Radiation
Intervention Name(s)
Pelvic Radiation
Intervention Description
Pelvic Radiation
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiotherapy (SBRT)
Intervention Description
SBRT: 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days)
Intervention Type
Radiation
Intervention Name(s)
Conventional Radiotherapy (CRT) Prostate Boost
Intervention Description
CRT: 33 - 35 Gy in 16 fractions (5 days per week - over 22 days)
Primary Outcome Measure Information:
Title
Short Term Quality of Life (QoL)
Description
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
Time Frame
up to 6 months post radiation
Secondary Outcome Measure Information:
Title
Long Term Quality of Life (QoL)
Description
long term QoL QoL, defined as bowel and bladder function and bother after PrCa treatment, will be measured prior to and at regular intervals up to 24 months month 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
Time Frame
24 months
Title
Urinary function assessment
Description
short and long term quality of urinary function (The International Prostate Symptom Score (IPSS)). Total IPSS is between 1-35 / lower score shows better function.
Time Frame
24 months
Title
Late Toxicity
Description
Grade 2-4 treatment related late (12-24 months), bladder and bowel related toxicity evaluated by the Expanded Common Toxicity Criteria of the National Cancer Institute of Canada (NCI)
Time Frame
12-24 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: • 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Theos Tsakiridis, Senior Principle Investigator, MD, FRCPC
Phone
905-387-9495
Email
theos.tsakiridis@hhsc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Naghmeh Isfahanian, Junior Principle Investigator, MD, FRCPC
Phone
289-707-4883
Email
isfahanian@hhsc.ca , naghmeh_isf@hotmail.com
Facility Information:
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theodorous Tsakiridis, MD, FRPC
First Name & Middle Initial & Last Name & Degree
Naghmeh Isfahanian, MD, FRCPC
Facility Name
Walker Family Cancer Centre ,Niagara Health - St. Catharines Site
City
St. Catharines
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theodoros Tsakiridis, MD, FRCPC

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Prostate Boost Irradiation With Stereotactic Body RT (SBRT)

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