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)

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: LHRH agonist; Radiation: Pelvic Radiation; Radiation: Conventional Radiotherapy (CRT) Prostate Boost; Radiation: Stereotactic Body Radiotherapy (SBRT)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Recruiting
      • Juravinski Cancer Centre
      • Principal Investigator: Theodorous Tsakiridis, MD, FRPC
      • Principal Investigator: Naghmeh Isfahanian, MD, FRCPC
    • St. Catharines, Ontario, Canada
      • Recruiting
      • Walker Family Cancer Centre ,Niagara Health - St. Catharines Site
      • Contact: Theodoros Tsakiridis, MD, FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist	Drug: LHRH agonist; Standard LHRH agonist for 3 years; Other Names: Eligard; Radiation: Pelvic Radiation; Pelvic Radiation; Radiation: Conventional Radiotherapy (CRT) Prostate Boost; CRT: 33 - 35 Gy in 16 fractions (5 days per week - over 22 days)
Experimental: Arm 2; Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist	Drug: LHRH agonist; Standard LHRH agonist for 3 years; Other Names: Eligard; Radiation: Pelvic Radiation; Pelvic Radiation; Radiation: Stereotactic Body Radiotherapy (SBRT); SBRT: 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months
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.	24 months
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)	12-24 months

Collaborators and Investigators

• Sponsor: Juravinski Cancer Center
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• 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)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 4178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No