Prostate Boost Irradiation With Stereotactic Body RT (SBRT)

Phase 2

• Conditions: Prostate Cancer
• Interventions: Drug: LHRH agonist; Radiation: Pelvic Radiation; Radiation: Conventional Radiotherapy (CRT) Prostate Boost; Radiation: Stereotactic Body Radiotherapy (SBRT)

• Registration Number: NCT03380806
• Lead Sponsor: Juravinski Cancer Center

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.

Study Timeline

• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-21
• Study Start: 2019-01-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Pelvic Radiation	Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist
Arm 1	Conventional Radiotherapy (CRT) Prostate Boost	Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist
Arm 2	Pelvic Radiation	Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist
Arm 1	LHRH agonist	Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist
Arm 2	LHRH agonist	Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist
Arm 2	Stereotactic Body Radiotherapy (SBRT)	Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist

Primary Outcome Measures

Name	Time	Method
Short Term Quality of Life (QoL)	up to 6 months post radiation	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

Name	Time	Method
Long Term Quality of Life (QoL)	24 months	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
Late Toxicity	12-24 months	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)
Urinary function assessment	24 months	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.

Trial Locations

Locations (2)

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Walker Family Cancer Centre ,Niagara Health - St. Catharines Site; 🇨🇦 St. Catharines, Ontario, Canada