Recruiting
Phase 2

SBRT

Sponsor:

Juravinski Cancer Center

Code:

NCT03380806

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LHRH agonist

Pelvic Radiation

Stereotactic Body Radiotherapy (SBRT)

Conventional Radiotherapy (CRT) Prostate Boost

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT03380806

Start date

Jan 1, 2019

Status verified date

Jun, 2020

Completion date

Jan 1, 2022

Anticipated

Primary completion date

Jan 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1

Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist

experimental: Arm 2

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

Interventions

LHRH agonist

Standard LHRH agonist for 3 years

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)

Primary outcome measure

  • Short Term Quality of Life (QoL) [ Time Frame: up to 6 months post radiation ]

Central Contacts and Locations

Central contacts

Theos Tsakiridis, Senior Principle Investigator, MD, FRCPC

905-387-9495theos.tsakiridis@hhsc.ca

Naghmeh Isfahanian, Junior Principle Investigator, MD, FRCPC

289-707-4883isfahanian@hhsc.ca , naghmeh_isf@hotmail.com

Locations

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada

Principal Investigator:

Theodorous Tsakiridis, MD, FRPC

Walker Family Cancer Centre ,Niagara Health - St. Catharines Site

Recruiting

St. Catharines, Ontario, Canada

More Information

Sponsor

Juravinski Cancer Center

Last update posted

Jun 4, 2020

Last verified

Jun, 2020

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)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Juravinski Cancer Center on 2020-06-04.