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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 :
No randomized trial has yet compared LDRB to SBRT head to head.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Stereotactic Body Radiation Therapy to the prostate | Experimental | Stereotactic Body Radiation Therapy to the prostate using 36.25 Gy in 5 fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, 3, 6, 9, 12, 18 and 24 months and then yearly after, up to 5 years. |
| Urinary function |
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Inclusion Criteria:
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]
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.
[EPIC-26: Expanded Prostate Cancer Index Composite score ; SHIM: Sexual Health Inventory for Men questionnaire].
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Thibault, MD, FRCPC | Contact | 418-525-4444 | 67296 | isabelle.thibault.med@ssss.gouv.qc.ca |
| Eric Vigneault, MD, FRCPC | Contact | 418-525-4444 | 67296 | eric.vigneault.med@ssss.gouv.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Isabelle Thibault, MD, FRCPC | CHU de Québec-Université Laval | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Intégré de Cancérologie, CHU de Québec-Université Laval | Recruiting | Québec | Quebec | G1J 1Z4 | Canada |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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
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| Stereotactic Body Radiation Therapy to the prostate | Radiation | Prostate Stereotactic Body Radiation Therapy using 36.25 Gy in 5 fractions |
|
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. |
| 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 | PSA measurement every 3 months after the procedure, during the first 3 years and then every 6 months, up to 5 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |