NCT03380806: PBS

Prostate Boost Irradiation With Stereotactic Body RT (SBRT)

Status unknown Phase 2 Last updated 4 June 2020

What this trial tests

Phase 2 trial testing LHRH agonist in Prostate Cancer in 100 participants. Status unknown.

Timeline

1 January 2019

Primary endpoint
1 January 2022

1 January 2022

Quick facts

Lead sponsor	Juravinski Cancer Center
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 January 2019
Primary completion	1 January 2022
Estimated completion	1 January 2022
Sites	2 locations across Canada

Drugs / interventions tested

• LHRH agonist (lhrh-agonist) — full drug profile →
• Pelvic Radiation
• Stereotactic Body Radiotherapy (SBRT) — full drug profile →
• Conventional Radiotherapy (CRT) Prostate Boost

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Juravinski Cancer Center

Who can join

Adults 18 to 85, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extreme Hypofractionation with SBRT in Localized Prostate Cancer.
   Gómez-Aparicio MA, Valero J, Caballero B, García R, et al · · 2021 · cited 22× · PMID 34436023 · DOI 10.3390/curroncol28040257
2. Stereotactic Body Radiotherapy: Hitting Harder, Faster, and Smarter in High-Risk Prostate Cancer.
   Correa RJM, Loblaw A. · · 2022 · cited 14× · PMID 35875062 · DOI 10.3389/fonc.2022.889132
3. Stereotactic Body Radiotherapy for Prostate Cancer.
   Parikh NR, Kishan AU. · · 2020 · cited 12× · PMID 32500805 · DOI 10.1177/1557988320927241
4. Stereotactic Radiation Therapy versus Brachytherapy: Relative Strengths of Two Highly Efficient Options for the Treatment of Localized Prostate Cancer.
   Kissel M, Créhange G, Graff P. · · 2022 · cited 8× · PMID 35565355 · DOI 10.3390/cancers14092226
5. A Randomized Phase II Trial of Prostate Boost Irradiation With Stereotactic Body Radiotherapy (SBRT) or Conventional Fractionation (CF) External Beam Radiotherapy (EBRT) in Locally Advanced Prostate Cancer: The PBS Trial (NCT03380806).
   Isfahanian N, Lukka H, Dayes I, Quan K, et al · · 2020 · cited 6× · PMID 32265129 · DOI 10.1016/j.clgc.2019.12.020
6. Enhancing Androgen Deprivation Therapy (ADT) integration in prostate cancer: Insights for Stereotactic Body Radiotherapy (SBRT) and brachytherapy modalities.
   Gomez-Iturriaga A, Büchser D, Lopez-Campos F, Maldonado X. · · 2024 · cited 5× · PMID 38322544 · DOI 10.1016/j.ctro.2024.100733
7. Primary Analysis of (NCT03380806) a Phase II Randomized Trial of Stereotactic Body Radiotherapy Boost Versus Conventional Fractionation External Beam Radiotherapy Boost in Unfavorable-Intermediate and High-Risk Prostate Cancer.
   Gouveia A, Mesci A, Isfahanian N, Dayes I, et al · · 2025 · cited 2× · PMID 40287937 · DOI 10.1002/pros.24905
8. Virtual HDR Boost for Prostate Cancer: Rebooting a Classic Treatment Using Modern Tech.
   Wegener E, Samuels J, Sidhom M, Trada Y, et al · · 2023 · cited 1× · PMID 37046680 · DOI 10.3390/cancers15072018