Prostate CancerNCT06052683
A Trial Evaluating Toxicity of SBRT and LDRB in Localized Prostate Cancer.
A study testing Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant and Stereotactic Body Radiation Therapy to the prostate in people with Prostate Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant and Stereotactic Body Radiation Therapy to the prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2019to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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].
Who cannot join
- 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.
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- 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,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Intégré de Cancérologie, CHU de Québec-Université Laval
Québec, Quebec, G1J 1Z4
Isabelle Thibault, MD, FRCPC, 418-525-4444 ext. 67296, isabelle.thibault.med@ssss.gouv.qc.ca
About this study
Official title: A Randomized Trial Evaluating Toxicity of Stereotactic Body Radiotherapy (SBRT) and Low-dose Rate Brachytherapy (LDRB) in Localized Prostate Cancer.
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 :
- 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)?
- 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.
Read the detailed description
Low-dose rate brachytherapy (LDRB) using Iodine-125 seed implant is known to be an effective definitive treatment for patients with low and favourable intermediate-risk prostate cancer. Mature data from Canadian institutions reported a biochemical progression-free survival as high as 90-95% at 5-10 years for patients with low and intermediate risk disease.
Prostate Stereotactic Body Radiotherapy (SBRT) as a single modality is a promising alternative to LDRB in low and favourable intermediate-risk prostate cancer. Some studies have shown the feasibility and efficacy of SBRT with low to intermediate risk-prostate cancer with 5-7 years PSA-progression-free survival really high (89,8% to 97,1% at a median follow-up of 5-7 years) [PSA: Prostate-Specific Antigen]. No randomized trial has yet compared LDRB to SBRT head to head.
Acute urinary toxicity is not trivial: a few studies have shown correlation between late urinary toxicity and the presence of acute urinary toxicity in patients treated with LDRB. Our research hypothesis is that SBRT for low and intermediate risk will result in fewer toxicities at the genito-urinary and the gastro-intestinal levels after 3 months of treatment.
- Conditions
- Prostate Cancer
- Being tested
- Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant, Stereotactic Body Radiation Therapy to the prostate
- Keywords
- Low-dose rate brachytherapy (LDRB), Stereotactic Body RadioTherapy (SBRT)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implantRadiation
Low-dose rate brachytherapy with Iodine-125 to a total dose of 144 Gy
Stereotactic Body Radiation Therapy to the prostateRadiation
Prostate Stereotactic Body Radiation Therapy using 36.25 Gy in 5 fractions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: Stereotactic Body Radiation Therapy to the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Evaluation according to the CTCAE version 4 to assess non-inferiority of SBRT compared to LDRB.
Number of toxicities events assessed
Measured: 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
Expanded Prostate Cancer Index Composite score (EPIC-26 questionnaire). In general terms, a higher score represents a better health-related quality of life.
Measured: At baseline, 3, 6, 9, 12, 18 and 24 months and then yearly after, up to 5 years.
Urinary function
International Prostate Symptom Score (IPSS score). The IPSS score is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Measured: 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 measurements
Measured: PSA measurement every 3 months after the procedure, during the first 3 years and then every 6 months, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start30 Sep 2019
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Thibault, MD, FRCPC, Study chair, CHU de Québec-Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052683
- Sponsor's protocol ID
- SBRT vs LDR-BT
- Status last verified
- Feb 2026
- First submitted
- 8 Sep 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Evaluating Toxicity of Stereotactic Body Radiotherapy (SBRT) and Low-dose Rate Brachytherapy (LDRB) in Localized Prostate Cancer.
- ClinicalTrials.gov ID
- NCT06052683
- Acronym / sponsor ID
- SBRT vs LDR-BT
- Conditions
- Prostate Cancer
- Keywords
- Low-dose rate brachytherapy (LDRB), Stereotactic Body RadioTherapy (SBRT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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)?
- 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.
Detailed description
Low-dose rate brachytherapy (LDRB) using Iodine-125 seed implant is known to be an effective definitive treatment for patients with low and favourable intermediate-risk prostate cancer. Mature data from Canadian institutions reported a biochemical progression-free survival as high as 90-95% at 5-10 years for patients with low and intermediate risk disease.
Prostate Stereotactic Body Radiotherapy (SBRT) as a single modality is a promising alternative to LDRB in low and favourable intermediate-risk prostate cancer. Some studies have shown the feasibility and efficacy of SBRT with low to intermediate risk-prostate cancer with 5-7 years PSA-progression-free survival really high (89,8% to 97,1% at a median follow-up of 5-7 years) [PSA: Prostate-Specific Antigen]. No randomized trial has yet compared LDRB to SBRT head to head.
Acute urinary toxicity is not trivial: a few studies have shown correlation between late urinary toxicity and the presence of acute urinary toxicity in patients treated with LDRB. Our research hypothesis is that SBRT for low and intermediate risk will result in fewer toxicities at the genito-urinary and the gastro-intestinal levels after 3 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant | Active comparator | Radiation: Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implantLow-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant to a total dose of 144 Gy. |
| Stereotactic Body Radiation Therapy to the prostate | Experimental | Radiation: Stereotactic Body Radiation Therapy to the prostateStereotactic Body Radiation Therapy to the prostate using 36.25 Gy in 5 fractions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
- [NCCN : National Comprehensive Cancer Network]
- Clinical stage T2b
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implantLow-dose rate brachytherapy with Iodine-125 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 prostateProstate Stereotactic Body Radiation Therapy using 36.25 Gy in 5 fractions | Radiation | Stereotactic Body Radiation Therapy to the prostate |
Primary outcome
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.
Number of toxicities events assessed
3 secondary outcomes
Quality of life issues in patients with prostate cancer
Time frame: At baseline, 3, 6, 9, 12, 18 and 24 months and then yearly after, up to 5 years.
Urinary function
Time frame: At baseline, 1, 3, 6. 9, 12, 18, 24 and 36 months after the procedure
Absolute PSA nadir to evaluate biochemical disease free survival.
Time frame: PSA measurement every 3 months after the procedure, during the first 3 years and then every 6 months, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle Thibault, MD, FRCPC study chair
CHU de Québec-Université Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant and Stereotactic Body Radiation Therapy to the prostate in people with Prostate Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Thibault, MD, FRCPC (418-525-4444 ext. 67296, isabelle.thibault.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.