Recruiting

Brachytherapy & Stereotactic Radiotherapy

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT04945642

Conditions

Prostate Adenocarcinoma

Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8

Stage IIC Prostate Cancer AJCC v8

Stage III Prostate Cancer AJCC v8

Stage IIIA Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High-Dose Rate Brachytherapy

Stereotactic Body Radiation Therapy

Study Details

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.

Conditions

Prostate Adenocarcinoma

Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8

Stage IIC Prostate Cancer AJCC v8

Stage III Prostate Cancer AJCC v8

Stage IIIA Prostate Cancer AJCC v8

Study ID

NCT04945642

Start date

Aug 20, 2021

Status verified date

Aug, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

52 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (HDR-BT, SBRT)

Patients undergo HDR-BT for up to 24 hours and undergo SBRT every other day or consecutive days for up to 14 consecutive chronologic days in the absence of disease progression or unacceptable toxicity.

Interventions

High-Dose Rate Brachytherapy

Undergo HDR-BT

Stereotactic Body Radiation Therapy

Undergo SBRT

Primary outcome measure

  • Biochemical failure [ Time Frame: Up to 5 years ]
  • Patient-reported genitourinary (GU) and gastrointestinal (GI) symptoms [ Time Frame: At 90 days ]

Central Contacts and Locations

Central contacts

Vince Basehart

310-267-8954vbasehart@mednet.ucla.edu

Maria Casado

310-794-6913mcasado@mednet.ucla.edu

Locations

University of California at Los Angeles / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Vince M. Basehart

310-267-8954vbasehart@mednet.ucla.edu

Principal Investigator:

Stephanie M. Yoon

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-08-20.