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

Launched by CHU DE QUEBEC-UNIVERSITE LAVAL · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for localized prostate cancer: Stereotactic Body RadioTherapy (SBRT) and Low-Dose Rate Brachytherapy (LDRB). The primary goals are to find out if SBRT causes fewer side effects related to urinary and digestive health compared to LDRB, and whether patients receiving SBRT have a better quality of life. So far, no studies have directly compared these two treatments, which makes this trial important.

To be eligible for the trial, participants must be men aged 18 or older with a confirmed diagnosis of prostate cancer that is either low-risk or favorable intermediate-risk. This includes specific criteria about the stage of cancer and certain test results. Participants will need to complete some questionnaires about their health and quality of life during the study. If you or someone you know is interested in participating, it’s essential to discuss this with a healthcare provider to see if it’s a good fit.

Gender

MALE

Eligibility 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,