Last updated: September 21, 2023
Sponsor: CHU de Quebec-Universite Laval
Overall Status: Active - Recruiting
Phase
N/A
Condition
Prostate Cancer
Prostate Cancer, Early, Recurrent
Urologic Cancer
Treatment
Stereotactic Body Radiation Therapy to the prostate
Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant
Clinical Study ID
NCT06052683
SBRT vs LDR-BT
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 8months. Patients on active surveillance with evidence of disease progression areeligible to the protocol as long as they meet the eligibility criteria and have arecent prostate biopsy (within 8 months).
- Low-risk and favourable intermediate-risk prostate cancer patients are eligibleaccording 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, withinthe 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 SHIMquestionnaires.
[EPIC-26: Expanded Prostate Cancer Index Composite score ; SHIM: Sexual Health Inventoryfor Men questionnaire].
Exclusion
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-melanomaskin 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-UrethralResection of the Prostate).
- Prior pelvic radiotherapy or prior radiotherapy that would result in overlap ofradiation 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 brachytherapyprocedure unsafe.
- Previous androgen deprivation therapy within 6 months of the registration.
- Bilateral hip prostheses
- Any severe active comorbidity, laboratory abnormality, psychiatric illnesses, activeor uncontrolled infections, serious illnesses or medical conditions that would preventthe patient from participating or to be managed according to the protocol (accordingto investigator's decision). Such examples includes active inflammatory bowel disease,significant urinary symptoms,
Study Design
Total Participants: 208
Treatment Group(s): 2
Primary Treatment: Stereotactic Body Radiation Therapy to the prostate
Phase:
Study Start date:
September 30, 2019
Estimated Completion Date:
September 30, 2026
Study Description
Connect with a study center
Centre Intégré de Cancérologie, CHU de Québec-Université Laval
Québec, G1J 1Z4
CanadaActive - Recruiting
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