Comparing two treatments for localized prostate cancer
A Randomized Trial Evaluating Toxicity of Stereotactic Body Radiotherapy (SBRT) and Low-dose Rate Brachytherapy (LDRB) in Localized Prostate Cancer.
NA · CHU de Quebec-Universite Laval · NCT06052683
This study is testing whether a new type of radiation therapy is safer and has fewer side effects than a different kind for men with early-stage prostate cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | CHU de Quebec-Universite Laval (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT06052683 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness and toxicity of Stereotactic Body RadioTherapy (SBRT) versus Low-Dose Rate Brachytherapy (LDRB) in patients with low and favorable intermediate-risk prostate cancer. The study will evaluate whether SBRT results in fewer genito-urinary and gastro-intestinal toxicities compared to LDRB, as well as assess the quality of life of patients receiving each treatment. By analyzing these factors, the trial seeks to provide valuable insights into the best treatment options for this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 18 and older with histologically confirmed low-risk or favorable intermediate-risk prostate cancer.
Not a fit: Patients with high-risk prostate cancer or those who have not been recently diagnosed may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options with fewer side effects for patients with localized prostate cancer.
How similar studies have performed: While there have been studies on SBRT and LDRB individually, this is the first randomized trial comparing the two treatments head to head.
Eligibility criteria
Show full inclusion / exclusion criteria
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,
Where this trial is running
Québec, Quebec
- Centre Intégré de Cancérologie, CHU de Québec-Université Laval — Québec, Quebec, Canada (RECRUITING)
Study contacts
- Study coordinator: Isabelle Thibault, MD, FRCPC
- Email: isabelle.thibault.med@ssss.gouv.qc.ca
- Phone: 418-525-4444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Low-dose rate brachytherapy, Stereotactic Body RadioTherapy