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New treatment option for Localized Prostate Carcinoma
Official title 24 Gy in One Fraction Urethral-sparing "HDR Like" SBRT for Prostate Cancer
ClinicalTrials.gov ID: NCT05936736
What this study is testing
- What it's testing
- Patients with prostate cancer who are candidates for stereotactic radiotherapy to the prostate and seminal vesicles will undergo staging exams, which will include prostate specific membrane antigen (PSMA) positron emission tomography-computed tomography (PET-CT). If the PET scan is negative and the uroflowmetry is acceptable, the patients will perform the treatment, after fiducial implantation, simulation CT and magnetic resonance (MR), in a single fraction, delivered with a high-dose-rate (HDR)-like urethral sparing technique.
- 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
- Histological diagnosis of prostate adenocarcinoma, International Society of Urological Pathology (ISUP) grade groups 1-5
- Patients over 18 years of age
- Signed informed consent
- Negative lymph nodes confirmed by imaging (PSMA PET/CT and/or pelvic MRI with and without contrast medium) where recommended by guidelines...
- Clinical M0 (PSMA PET/CT and/or bone scan and/or pelvic MRI with and without contrast medium in suspected patients and unfavorable intermediate and...
You likely can't join if
- Serious systemic diseases
- Psychic or other disorders that may prevent the patient from signing the informed consent
- Previous invasive cancer, except skin cancer (excluding melanoma) unless patient free of disease for at least 3 years (e.g. carcinoma in situ of the...
- Lymph node disease (N1)
- Evidence of distant metastases (M1)
- IPSS questionnaire data \> 20 points
See the full eligibility criteria
- Histological diagnosis of prostate adenocarcinoma, International Society of Urological Pathology (ISUP) grade groups 1-5
- Patients over 18 years of age
- Signed informed consent
- Negative lymph nodes confirmed by imaging (PSMA PET/CT and/or pelvic MRI with and without contrast medium) where recommended by guidelines (intermediate and high risk patients, according to National Comprehensive Cancer...
- Clinical M0 (PSMA PET/CT and/or bone scan and/or pelvic MRI with and without contrast medium in suspected patients and unfavorable intermediate and high risk patients, according to NCCN guidelines), in the previous 3...
- Acceptable uroflowmetry: peak urine flow index (peak flow preferably ≥ 15 ml/s), post voiding residue (PVR) ≤50 cc. If lower, acceptable if, by carrying out 3 months of neoadjuvant hormone therapy + alpha-lytic for the...
- PS (ECOG) ≤2
- No previous pelvic radiotherapy
- Other conditions necessary for the correct execution of the proposed treatment (ability to fill in the questionnaires for the evaluation of the Quality of Life EORTC QLQ-C30, EORTC QLQ-PR25, IPSS, IIEF-5, EPIC 26)
- Serious systemic diseases
- Psychic or other disorders that may prevent the patient from signing the informed consent
- Previous invasive cancer, except skin cancer (excluding melanoma) unless patient free of disease for at least 3 years (e.g. carcinoma in situ of the oral cavity or bladder)
- Lymph node disease (N1)
- Evidence of distant metastases (M1)
- IPSS questionnaire data \> 20 points
- Uroflowmetry with maximum basal flow ≤ 11 ml/sec and/or PVR \>100 ml
- Concomitant urinary/gastrointestinal inflammatory diseases (e.g. ulcerative colitis, Crohn's disease)
- Overactive bladder
- Impossibility of implantation of fiducials
- Inability or refusal to place bladder catheter for simulation CT and MR
- Inability to perform simulation MRI
- Contraindication for hormonal treatment for patients with unfavorable intermediate, high or very high risk disease
- Non-compliance with dose limits established in the treatment plan
The study team makes the final eligibility decision.
Where it's taking place
- Milan, MI, Italy
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 Milan, MI, Italy. 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.