Pelvic Nodes Ultra-Hypo vs Conventionally Fractionated IMRT With HDR Boost in Prostate Cancer.

Summary

Randomized Phase III study, comparing pelvic ultra-hypo fractionated radiotherapy (UHF: 5Gy/fraction) to a standard or moderate hypo-fractionation (1.8-2.15Gy/fraction), both associated to an HDR prostate +/- adjacent seminal vesicles brachytherapy boost (HDR-BT)+ ADT according to NCCN guidelines. Considering that the calculated bio-equivalent doses to the tumor are similar for all treatment options, the UHF technique is deemed to be non-inferior to the standard approach. Treatment acceptability, tolerance and adverse events will be reported and compared for non-inferiority as the primary objective. Secondary objectives are biochemical control, metastasis-free, disease specific and overall survival.

Conditions

• Prostate Cancer
• Node; Prostate
• Radiotherapy Side Effect

Interventions

RADIATION

Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS)

Assess early and late genito-urinary (GU) toxicities induced assessed via the International Prostate Symptom Score (I-PSS) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).

RADIATION

Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):

Assess early and late genito-urinary (GU) and gastro-intestinal (GI) toxicities induced and quality of life assessed via expanded prostate cancer index composite (EPIC-26) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).

RADIATION

Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM)

Assess early and late sexual health in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).

RADIATION

Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE)

Assess early and late toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).

RADIATION

Report and compare the biochemical disease free survival (bDFS)

Assess the 5 and 10 years biochemical disease-free survival (bDFS) in the UHF group and compare them for non-inferiority to those of the control group.

RADIATION

Report and compare the disease free survival (DFS)

Assess the 5 and 10 years disease-free survival (DFS) in the UHF group and compare them for non-inferiority to those of the control group.

RADIATION

Report and compare the metastase free survival (MFS)

Assess the 5 and 10 years metastasis-free survival (MFS) in the UHF group and compare them for non-inferiority to those of the control group.

RADIATION

Report and compare the overall survival (OS)

Assess the 5 and 10 years overall survival (OS) in the UHF group and compare them for non-inferiority to those of the control group.

Sponsors & Collaborators

• TerSera Therapeutics LLC

  collaborator INDUSTRY

• CHU de Quebec-Universite Laval

  lead OTHER

Principal Investigators

• Andre-Guy Martin, MD MSc FRCPC · Andre-Guy Martin MD Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

95 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2026-11-30

Completion

2035-12-31

Countries

• Canada

Study Locations