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

Joelle Helou

Status and phase

Not yet enrolling

Phase 2

Conditions

Prostate Cancer

Treatments

Radiation: Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost

Radiation: Experimental Arm: Focal High Dose Rate Brachytherapy Boost

Study type

Interventional

Funder types

Other

Identifiers

NCT07300566

FORWARD - ReDA 16623

Details and patient eligibility

About

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.

Enrollment

58 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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