NCT04100174RecruitingPhase 2
Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy
Centre hospitalier de l'Université de Montréal (CHUM)2 sites in 1 country150 target enrollmentStarted: July 1, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Urinary Quality of Life
Study Overview
Brief Summary
To determine if fBT+sRT is superior to standard care in terms of urinary toxicity by having fewer patients experience a minimal important decline (MID) in urinary irritation/obstructive QoL
Detailed Description
In this Phase IIR trial investigators primarily seek to determine if fBT boost (15Gy) to SBRT (35Gy/5) can be shown to be superior to standard care (whole-gland BT boost 15Gy to RT 37.5Gy/15) in terms of urinary toxicity by having fewer patients experience a minimal important decline (MID) in urinary irritation/obstructive QoL as measured by ePRO (EPIC-26) at 12 and 24 months post completion of therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histological diagnosis of prostate cancer planned for curative-intent HDR brachytherapy boost to external beam radiotherapy to the prostate gland.
- •Charlson Comorbidity Index ≤ 4
- •Imaging visible disease encompassing < 50% of the prostate gland and consistent with biopsy findings.
- •Exclusion - none
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Urinary Quality of Life
Time Frame: 12-24 months
EPIC
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Terminated
Phase 2
Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine MetastasisPrimary TumorMetastatic CancerNCT01525745Beth Israel Deaconess Medical Center6
Recruiting
Not Applicable
Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different SitesSafety and EfficacyRadiotherapyThoracic CancerNCT05349552Peking University Third Hospital120
Unknown
Phase 2
SBRT Compared With IMRT Concurrently With Chemotherapy in Treating Patients With LS-SCLCSmall Cell Lung CancerNCT02738723Third Military Medical University50
Recruiting
Not Applicable
VIBE - Virtual Image Guided Brachytherapy Emulation for Locally Advanced Cervical Cancer (LACC)Cervical CancerNCT06394297Fundacao Champalimaud30
Active, not recruiting
Phase 3
SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate AdenocarcinomaBiochemically Recurrent Prostate CarcinomaRecurrent Prostate AdenocarcinomaOligometastatic Prostate CarcinomaStage IV Prostate Cancer AJCC v8Stage IIB Prostate Cancer AJCC v8Stage IIC Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8NCT06205316Mayo Clinic118