🔎 Trials Near Me

Home › Prostate Cancer › NCT04945642

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

Recruiting

Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)

Who can join

Ages 18 and older · Men

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Jonsson Comprehensive Cancer Center · Participants: 52 · Started: Aug 20, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04945642

Locations in the U.S.

CaliforniaUniversity of California at Los Angeles / Jonsson Comprehensive Cancer Center, Los Angeles

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.