A Randomized Phase II Trial Investigating Stereotactic Body RadioTherapy (SBRT) for Prostate Boost Irradiation in the Treatment of High Risk Prostate Cancer (PrCa)
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Short Term Quality of Life (QoL)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 1
Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist
Intervention: LHRH agonist (Drug)
Arm 1
Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist
Intervention: Pelvic Radiation (Radiation)
Arm 1
Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist
Intervention: Conventional Radiotherapy (CRT) Prostate Boost (Radiation)
Arm 2
Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist
Intervention: LHRH agonist (Drug)
Arm 2
Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist
Intervention: Pelvic Radiation (Radiation)
Arm 2
Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist
Intervention: Stereotactic Body Radiotherapy (SBRT) (Radiation)
Outcomes
Primary Outcomes
Short Term Quality of Life (QoL)
Time Frame: 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 Outcomes
- Long Term Quality of Life (QoL)(24 months)
- Late Toxicity(12-24 months)
- Urinary function assessment(24 months)
Investigators
Naghmeh Isfahanian
Term Professional staff
Juravinski Cancer Center