Combining high dose-rate brachytherapy and stereotactic body radiotherapy for prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of combining high dose-rate brachytherapy with stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. The approach utilizes internal radiation therapy to deliver radioactive material directly into or near the tumor, alongside highly precise external radiation therapy. The primary objectives include estimating the biochemical progression-free survival at five years and assessing the rates of acute genitourinary and gastrointestinal symptoms following treatment. Secondary objectives focus on long-term patient-reported outcomes and toxicity assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ability to understand a written informed consent document, and the willingness to sign it
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
* Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \> 10, and/or Gleason score \>= 7
* No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)
* Prostate size =\< 60cc
* International Prognostic Scoring System (IPSS) score =\< 15
* Able to safely receive moderate sedation or general anesthesia

Exclusion Criteria:

* Patients with neuroendocrine or small cell carcinoma of the prostate
* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years
* Regional lymph node involvement
* Evidence of distant metastases
* Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer
* Previous pelvic irradiation or prostate brachytherapy
* Previous or concurrent cytotoxic chemotherapy for prostate cancer
* Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), high predisposition for radio-toxicity compared to general population (i.e., ataxia telangiectasia), or at risk for major bowel surgery
* Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment

Where it's running

• University of California at Los Angeles / Jonsson Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Stephanie M Yoon, MD — University of California, Los Angeles
• Study coordinator: Vince Basehart
• Email: vbasehart@mednet.ucla.edu
• Phone: 310-267-8954

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.