Prostate Boost Irradiation With Stereotactic Body RT (SBRT)

Prostate Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03380806
• Other study ID #: 4178
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: June 2020
• Source: Juravinski Cancer Center
• Contact: Theos Tsakiridis, Senior Principle Investigator, MD, FRCPC
• Phone: 905-387-9495
• Email: theos.tsakiridis[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• LHRH agonist
Standard LHRH agonist for 3 years

Radiation:
• Pelvic Radiation
Pelvic Radiation
• Stereotactic Body Radiotherapy (SBRT)
SBRT: 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days)
• Conventional Radiotherapy (CRT) Prostate Boost
CRT: 33 - 35 Gy in 16 fractions (5 days per week - over 22 days)

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Walker Family Cancer Centre ,Niagara Health - St. Catharines Site	St. Catharines	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Juravinski Cancer Center	Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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