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New treatment option for Prostate Cancer
Official title A Trial Evaluating Toxicity of SBRT and LDRB in Localized Prostate Cancer.
ClinicalTrials.gov ID: NCT06052683
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 8 months. Patients on active surveillance with evidence of disease...
- Low-risk and favourable intermediate-risk prostate cancer patients are eligible according to the following definitions: Low-risk disease defined as...
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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, 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].
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Québec, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.