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High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma

About

Brief Summary

This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
Male
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

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Study Stats
Protocol No.
21-000704
Category
Oncology
Radiation Oncology
Principal Investigator
STEPHANIE YOON
Contact
Maria Casado
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04945642
For detailed technical eligibility, visit ClinicalTrials.gov.