A Trial Evaluating Toxicity of SBRT and LDRB in Localized Prostate Cancer.

NCT06052683 | Recruiting

• 1 other identifier: SBRT vs LDR-BT
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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. 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. 2.Does prostate cancer patients treated by SBRT have a better quality of life than patients treated by LDRB

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Adverse Event Evaluation according to the CTCAE version 4 to assess non-inferiority of SBRT compared to LDRB.

  Number of toxicities events assessed

  1, 3, 6, 9, 12, 18, 24 months after end of treatment and yearly after, up to 5 years.

Secondary Outcomes (3)

• Quality of life issues in patients with prostate cancer

  At baseline, 3, 6, 9, 12, 18 and 24 months and then yearly after, up to 5 years.

• Urinary function

  At baseline, 1, 3, 6. 9, 12, 18, 24 and 36 months after the procedure

• Absolute PSA nadir to evaluate biochemical disease free survival.

  PSA measurement every 3 months after the procedure, during the first 3 years and then every 6 months, up to 5 years

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

Stereotactic Body Radiation Therapy to the prostate

EXPERIMENTAL

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

Radiation: Stereotactic Body Radiation Therapy to the prostate

Interventions

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

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

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

Stereotactic Body Radiation Therapy to the prostate RADIATION

Prostate Stereotactic Body Radiation Therapy using 36.25 Gy in 5 fractions

Stereotactic Body Radiation Therapy to the prostate

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \[NCCN : National Comprehensive Cancer Network\]
• Clinical stage T2b
• PSA \> 10 but ≤ 20 ng/mL
• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

Centre Intégré de Cancérologie, CHU de Québec-Université Laval

Québec, Quebec, G1J 1Z4, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Isabelle Thibault, MD, FRCPC

  CHU de Québec-Université Laval

  STUDY CHAIR

Central Study Contacts

Isabelle Thibault, MD, FRCPC

CONTACT

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

Eric Vigneault, MD, FRCPC

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For the pilot study, patients will be randomized to receive one of the following treatments to a planned sample size of 48 patients. 24 patients will be randomized in each treatment arms. Once the pilot study will be completed, the investigators will conduct the large-scale research study enrolling 208 patients

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 25, 2023
• Study Start: September 30, 2019
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)