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Not yet recruiting NCT07300566

Focal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost to External Beam Radiotherapy in Localized Prostate Cancer: A Phase 2 Randomized Trial

Phase II Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost, Experimental Arm: Focal High Dose Rate Brachytherapy Boost.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

FOcal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost With ExternAl Beam Radiotherapy in LocalizeD Prostate Cancer: A Phase 2 Randomized Trial [FORWARD]

Overview

This project aims to compare the changes in the urinary quality of life (QoL) following focal high dose-rate brachytherapy (HDR-BT) boost to stereotactic ablative radiotherapy (SABR), compared to standard whole gland HDR-BT boost, in the treatment of men diagnosed with intermediate- and high-risk prostate cancer, with have an identifiable DIL on mpMRI.

Interventions

  • Radiation Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost
    Whole gland high dose rate brachytherapy (15 Gray/1 fraction) plus stereotactic ablative radiotherapy to the prostate +/- pelvis (25 Gray/5 fractions). Androgen deprivation therapy 6 to 24 months (physician discretion).
  • Radiation Experimental Arm: Focal High Dose Rate Brachytherapy Boost
    Focal high dose rate brachytherapy boost to the dominant intraprostatic lesion (15 Gray/1 fraction) plus stereotactic ablative radiotherapy to the prostate (30 Gray/5 fractions) +/- the pelvis (25 Gray/5 fractions). Androgen deprivation therapy 6 to 24 months (physician discretion).

Primary outcome measures

  • Changes in Urinary Quality of Life at 24 Months Measured by the Expanded Prostate Index Composite (EPIC-26) Questionnaire [Time frame: From enrollment to 24 months post radiation therapy]
Secondary outcome measures (6)
  • Acute Changes in Urinary, Bowel, and Sexual Quality of Life [Time frame: Less than or equal to 6 months post radiation therapy]
  • Long Term Changes in Bowel and Sexual Quality of Life Measured by Expanded Prostate Index Composite (EPIC-26) Questionnaire [Time frame: From enrollment to 24 months post radiation therapy]
  • Acute and Chronic Physician-Reported Toxicity Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [Time frame: From enrollment to 24 months post radiation therapy]
  • Prostate Specific Antigen (PSA) at 4 years [Time frame: 4 years post radiation therapy]
  • Biochemical Control Measure by Prostate Specific Antigen (PSA) Levels [Time frame: Enrollment to 5 years post radiation therapy]
  • Participant reported Symptoms Measured by the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Time frame: From enrollment to 24 months post radiation therapy]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate
  • Eastern Co-Operative Oncology Group (ECOG) 0-2
  • Intermediate and high-risk disease with localized unfavorable features:
  • defined as clinical stage tumor cT1 or cT2a, International Society of Urological Pathology (ISUP) grade group 2-4 in less than or equal to 50% of the cores, unilateral extracapsular extension (ECE), prostate specific antigen (PSA) less than or equal to 20 ng/mL
  • corresponding to an Identified dominant intraprostatic lesion (DIL) on multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging Reporting and Data System score (PI-RADs 3-5)
  • Prostate volume less than or equal to 60 cc is recommended. Transrectal ultrasound (TRUS) and magnetic resonance imaging (MRI) are accepted to assess prostate volume. Patients with a prostate volume between 60 and 80 cc can be included if the International Prostate Symptom Score (IPSS) is less than 15 and brachytherapy is deemed feasible by the treating physician.

Exclusion criteria

  • Contraindications to mpMRI
  • Documented nodal or distant metastases
  • Previous pelvic radiotherapy
  • Recent transurethral resection of prostate (less than or equal to 6 months), previous prostatectomy or high-intensity focused ultrasound (HIFU)
  • Poor baseline urinary function: International Prostate Symptom Score (IPSS) greater than 19
  • Connective tissue disease or inflammatory bowel disease
  • Patients deemed unsuitable for general anaesthetic by the Anaesthesia Department
  • Patient is unable to lie flat long enough for the Radiation Therapy (RT) Simulation and Treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • London Health Sciences Centre, Verspeeten Family Cancer Centre — London

Identifiers

NCT: NCT07300566 · FORWARD - ReDA 16623

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗