RecruitingNot applicable

High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer

High-dose Rate (HDR) Brachytherapy Boost With Stereostatic Body Radiation Therapy (SBRT) to Prostate and Pelvic Nodes for the Initial Treatment of Unfavorable Intermediate or Higher Risk Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies, Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The sample size will be 53 patients, with biopsy confirmed unfavorable-intermediate or higher risk prostate cancer and ≥ 15% probability of nodal involvement as determined by publicly available nomograms."
  • "Eligible patients will undergo ultrasound-guided HDR brachytherapy to the whole prostate to a dose of 15 Gy in 1 fractions followed by SBRT to a dose of 25 Gy in 5 fractions given every other day."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and effects of two types of radiation used together for prostate cancer. It combines focused radiation beams to the prostate and nearby lymph nodes with high-dose radiation placed inside the prostate. It is for people whose cancer has not spread and is in an unfavorable intermediate-risk or higher-risk group.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 19 or older, with a biopsy showing prostate cancer in an unfavorable intermediate-risk or higher-risk group.
  • No prior treatment or procedure to treat the prostate cancer.
  • Your doctor expects you to live more than 10 years.
  • Scans show no cancer spread to lymph nodes, bones, or other distant parts of the body.
  • A risk tool estimates at least a 15% chance of cancer in nearby lymph nodes.
  • Able to do most normal activities, with some signs or symptoms of illness allowed. This must be checked within 30 days before joining.
  • Your doctor says you can receive high-dose radiation placed inside the prostate.
  • Able to give informed consent, meaning you understand the study and agree to join.

Who can't join

  • A score of 15 or higher on the AUA survey of urinary symptoms.
  • A prostate larger than 75 cc, or a prostate size and pelvic bone shape that could block placement of the radiation tools.
  • Mental health, family, social, or location issues that could prevent following study rules or attending follow-up visits.
  • A condition that makes radiation unsafe, such as certain bowel, connective tissue, or genetic diseases; another condition that could put your safety at risk; or inability to safely receive general anesthesia, medicine that puts you to sleep.
  • A prior invasive cancer other than prostate cancer, unless you have been cancer-free for at least 1 year. Non-melanoma skin cancer is allowed.
  • Past rectal surgery, or a rectal fistula—an abnormal tunnel from the rectum to another area.
  • Major surgery, a biopsy done through a surgical cut, or a serious injury within 30 days before joining.
  • A past UroLift procedure to help urine flow.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 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 institution. 2. No prior definitive treatment or intervention received. 3. Life expectancy of more than 10 years as estimated by the treating physician. 4. Negative evaluation lymph node involvement or distant metastatic disease on abdominopelvic CT, prostate MRI, and/or PSMA PET. 5. Negative evaluation of osseous metastatic disease via bone scan or PSMA PET scan. 6. Greater than or equal to 15% nodal involvement risk predicated on publicly available MSKCC pre-prostatectomy nomogram. 7. Karnofsky performance status ≥ 80 within 30 days prior to registration. 8. Age ≥ 19 years. 9. Clinically determined to be a candidate for HDR brachytherapy. 10. Patient must be able to provide study-specific informed consent prior to study entry. Exclusion Criteria: 1. American Urological Association Urinary Symptom Score (AUA score) ≥ 15. 2. 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, prostates must be no greater than 75 cc in size as decerned by MRI, TRUS, or physical exam. Potential for pubic arch interference will be decerned by the treating radiation oncologist based on MRI and/or CT imaging. 3. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. 4. 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 erythematosus, scleroderma, etc.), genetic disorders that risk increase sensitivity to radiation therapy. 5. Medical conditions that, in the opinion of the investigator could compromise patient safety. 6. Prior invasive malignancy other than prostate cancer (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year. 7. History of rectal surgeries. 8. Recent major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to registration. 9. History of Urolift. 10. Contraindications to general anesthesia. 11. Preexisting rectal fistula.

Study sites (1)

NE