NCT04945642Recruiting
High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma
Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 14 Jun 2021
- Start date
- 20 Aug 2021
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT04945642
What you commit to
- Study type: Interventional
- Planned participants: 52
- From 20 Aug 2021 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years
- 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
- Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment
Other illness
- 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
Other
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Regional lymph node involvement
- Evidence of distant metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California at Los Angeles / Jonsson Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.