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New treatment option for High Risk Prostate Cancer
Official title Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-Risk Prostate Cancer
ClinicalTrials.gov ID: NCT07189598
What this study is testing
- What it's testing
- The aim of this clinical trial is to evaluate the efficacy of adaptive prostate Stereotatic Body RadioTherapy (SBRT), which integrates both Whole Pelvic RadioTherapy (WPRT) and dose escalation on the Dominant Intraprostatic Lesion (DIL), compared with standard radiotherapy. This will be assessed using a 5-year cost-utility analysis based on data from the clinical trial and the National Health Data System (NHDS).
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
- Male.
- Age ≥ 18 years
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Histologically proven prostate adenocarcinoma, not previously treated
- High-risk or very high-risk according to the National Comprehensive Cancer Network (NCCN) :
You likely can't join if
- Presence of nodal or distant metastases
- Stage T4.
- Prostate volume \> 80 cm3.
- IPSS \>19/35.
- Previous local treatment of prostate adenocarcinoma (HIFU (High-Intensity Focused Ultrasound), cryotherapy)
- Previous TransUrethral Resection of the prostate (PTUR)).
See the full eligibility criteria
- Male.
- Age ≥ 18 years
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Histologically proven prostate adenocarcinoma, not previously treated
- High-risk or very high-risk according to the National Comprehensive Cancer Network (NCCN) :
- T3a / T3b (proximal extension only),
- and/or ISUP (International Society of Urological Pathology) grade 4-5,
- and/or PSA (Prostate-Specific Antigen) 20ng/mL
- Non-metastatic, as proven by Prostate Specific Membrane Antigen (PSMA) positron emission tomography/computed tomography (PET/CT) and pelvic MRI (Magnetic Resonance Imaging) less than 2 months before starting hormone...
- Normal testosterone levels prior to hormone therapy
- Ability to give consent for inclusion in the study
- Acceptance of treatment and monitoring modalities
- Presence of nodal or distant metastases
- Stage T4.
- Prostate volume \> 80 cm3.
- IPSS \>19/35.
- Previous local treatment of prostate adenocarcinoma (HIFU (High-Intensity Focused Ultrasound), cryotherapy)
- Previous TransUrethral Resection of the prostate (PTUR)).
- Previous pelvic radiotherapy.
- Chronic inflammatory bowel disease.
- Active cardiovascular comorbidities (e.g. myocardial infarction or ischemic stroke within the last 6 months).
The study team makes the final eligibility decision.
Where it's taking place
- Rennes, France
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 Rennes, France. 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.