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New treatment option for Prostatic Cancer
Official title High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer
ClinicalTrials.gov ID: NCT05754580
What this study is testing
- What it's testing
- The objective of this phase I/II trial is to prospectively evaluate the toxicity and therapeutic efficacy of Stereostatic Body Radiation Therapy (SBRT) to prostate and pelvic lymph nodes in combination with high-dose-rate (HDR) brachytherapy to the prostate in patients with localized unfavorable-intermediate risk or higher disease.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older, men only
You may be able to join if
- Histopathologically proven diagnosis of local unfavorable intermediate or higher risk prostate cancer as defined by NCCN risk group criteria...
- No prior definitive treatment or intervention received.
- Life expectancy of more than 10 years as estimated by the treating physician.
- Negative evaluation lymph node involvement or distant metastatic disease on abdominopelvic CT, prostate MRI, and/or PSMA PET.
- Negative evaluation of osseous metastatic disease via bone scan or PSMA PET scan.
You likely can't join if
- American Urological Association Urinary Symptom Score (AUA score) ≥ 15.
- Large prostate volume relative to pelvic arch width that can hinder proper placement of applicator insertion. To be done by MRI, TRUS, and/or...
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and...
- Relative or absolute contraindications to radiation therapy as determined by the treating physician. These include, but not limited to, inflammatory...
- Medical conditions that, in the opinion of the investigator could compromise patient safety.
- Prior invasive malignancy other than prostate cancer (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year.
See the full eligibility criteria
- Histopathologically proven diagnosis of local unfavorable intermediate or higher risk prostate cancer as defined by NCCN risk group criteria. Biopsies will be confirmed by UNMC pathology review if collected outside our...
- No prior definitive treatment or intervention received.
- Life expectancy of more than 10 years as estimated by the treating physician.
- Negative evaluation lymph node involvement or distant metastatic disease on abdominopelvic CT, prostate MRI, and/or PSMA PET.
- Negative evaluation of osseous metastatic disease via bone scan or PSMA PET scan.
- Greater than or equal to 15% nodal involvement risk predicated on publicly available MSKCC pre-prostatectomy nomogram.
- Karnofsky performance status ≥ 80 within 30 days prior to registration.
- Age ≥ 19 years.
- Clinically determined to be a candidate for HDR brachytherapy.
- Patient must be able to provide study-specific informed consent prior to study entry.
- American Urological Association Urinary Symptom Score (AUA score) ≥ 15.
- Large prostate volume relative to pelvic arch width that can hinder proper placement of applicator insertion. To be done by MRI, TRUS, and/or physical exam for size, by CT A/P or MRI for arch interference. Specifically...
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Relative or absolute contraindications to radiation therapy as determined by the treating physician. These include, but not limited to, inflammatory bowel disease, connective tissue disorders (systemic lupus...
- Medical conditions that, in the opinion of the investigator could compromise patient safety.
- Prior invasive malignancy other than prostate cancer (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year.
- History of rectal surgeries.
- Recent major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to registration.
- History of Urolift.
- Contraindications to general anesthesia.
- Preexisting rectal fistula.
The study team makes the final eligibility decision.
Where it's taking place
- Omaha, Nebraska, United States
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, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Omaha, Nebraska, United States. 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.