Recruiting

SBRT vs. LDRB

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT06052683

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant

Stereotactic Body Radiation Therapy to the prostate

Study Details

Brief summary:

The goal of this clinical trial is to compare SBRT (Stereotactic Body RadioTherapy) to LDRB (Low-Dose Rate Brachytherapy with Iodine-125 seed implant) in patients with low and favourable intermediate-risk prostate cancer. The two main questions it aims to answer are :

1. Does SBRT (Stereotactic Body RadioTherapy) for low and intermediate risk prostate cancer patients will result in less genito-urinary (GU) and gastro-intestinal (GI) toxicities than LDRB (Low-Dose Rate Brachytherapy)?
2. Does prostate cancer patients treated by SBRT have a better quality of life than patients treated by LDRB

No randomized trial has yet compared LDRB to SBRT head to head.

Conditions

Prostate Cancer

Study ID

NCT06052683

Start date

Sep 30, 2019

Status verified date

Feb, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 8 months. Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the eligibility criteria and have a recent prostate biopsy (within 8 months).
  • Low-risk and favourable intermediate-risk prostate cancer patients are eligible according to the following definitions:

Low-risk disease defined as: Clinical stage T1-T2a and Gleason 6 and PSA ≤ 10 ng/mL

Favourable intermediate-risk cancer defined by a single NCCN intermediate risk factor:

\[NCCN : National Comprehensive Cancer Network\]

1. Clinical stage T2b
2. PSA > 10 but ≤ 20 ng/mL
3. Gleason 7 (3+4)

Lymph node evaluation by either computed tomography (CT) or magnetic resonance imaging (MRI) is optional and is left at the discretion of the treating physician.

  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group performance status 0-1
  • Patient considered medically fit for LDR brachytherapy
  • Prostate volume ≤ 60 cc, measured by Trans-Rectal UltraSound (TRUS), CT or MRI, within the last 6 months.
  • International Prostate Symptom Score (IPSS) ≤ 20 (alpha blockers allowed)
  • No alpha reductase inhibitors use within two weeks of randomization
  • No hormonal therapy is accepted
  • Patients must provide a study-specified informed consent form prior to study entry.
  • Patients must be willing and able to complete the EPIC-26, IPSS and SHIM questionnaires.

\[EPIC-26: Expanded Prostate Cancer Index Composite score ; SHIM: Sexual Health Inventory for Men questionnaire\].

Exclusion Criteria:

  • Clinical or radiological evidence of metastatic disease or nodal involvement.
  • Clinical stage ≥ T2b.
  • Gleason score ≥ 4 + 3.
  • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years.
  • Prior radical surgery for carcinoma of the prostate, or prior TURP (Trans-Urethral Resection of the Prostate).
  • Prior pelvic radiotherapy or prior radiotherapy that would result in overlap of radiation fields.
  • Prior chemotherapy for prostate cancer, or prior chemotherapy within the last 3 years.
  • Prior cryosurgery of the prostate.
  • Prior or current bleeding diathesis making fiducial placement or brachytherapy procedure unsafe.
  • Previous androgen deprivation therapy within 6 months of the registration.
  • Bilateral hip prostheses
  • Any severe active comorbidity, laboratory abnormality, psychiatric illnesses, active or uncontrolled infections, serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision). Such examples includes active inflammatory bowel disease, significant urinary symptoms,

Study Design

Enrollment

208 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant

Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant to a total dose of 144 Gy.

experimental: Stereotactic Body Radiation Therapy to the prostate

Stereotactic Body Radiation Therapy to the prostate using 36.25 Gy in 5 fractions.

Interventions

Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant

Low-dose rate brachytherapy with Iodine-125 to a total dose of 144 Gy

Stereotactic Body Radiation Therapy to the prostate

Prostate Stereotactic Body Radiation Therapy using 36.25 Gy in 5 fractions

Primary outcome measure

  • Adverse Event Evaluation according to the CTCAE version 4 to assess non-inferiority of SBRT compared to LDRB. [ Time Frame: 1, 3, 6, 9, 12, 18, 24 months after end of treatment and yearly after, up to 5 years. ]

Central Contacts and Locations

Central contacts

Isabelle Thibault, MD, FRCPC

418-525-4444isabelle.thibault.med@ssss.gouv.qc.ca

Eric Vigneault, MD, FRCPC

418-525-4444eric.vigneault.med@ssss.gouv.qc.ca

Locations

Centre Intégré de Cancérologie, CHU de Québec-Université Laval

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Contacts

Isabelle Thibault, MD, FRCPC

418-525-4444isabelle.thibault.med@ssss.gouv.qc.ca

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Low-dose rate brachytherapy (LDRB)
  • Stereotactic Body RadioTherapy (SBRT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2026-02-17.