NCT01655836Active, not recruitingPhase 1
High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
Phase I Trial of High Dose Rate Brachytherapy Combined With Stereotactic Body Radiation Therapy for Intermediate Risk Prostate Cancer Patients
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
The first technology is called high dose rate brachytherapy. Brachytherapy is sometimes called internal radiation therapy. High dose rate brachytherapy is a procedure that involves temporarily placing radioactive material inside the patient's body for about 10-20 minutes. Then, the remainder of the radiation treatment will be given over a 3 week period using stereotactic body radiation therapy (SBRT). SBRT is a novel treatment modality that involves the delivery of very high individual doses of radiation to tumors with high precision. This allows the doctor to deliver the same amount of radiation in a much shorter time. The purpose of this study is to determine the safety of brachytherapy when combined with hypofractionated SBRT.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 31 Jul 2012
- Start date
- 4 Oct 2012
- Primary completion date
- 27 Jul 2016
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Diseases
- Prostate cancer
- NCT number
- NCT01655836
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 42
- From 4 Oct 2012 to the primary completion date, 27 Jul 2016
- 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
- History of prior pelvic irradiation
- Prior radical prostatectomy or cryosurgery for prostate cancer
Other illness
- History of urological surgery or procedures predisposing to GU complications after radiation, i.e., anastomoses, stricture repair, etc. (will be determined by radiation oncologist)
- Documented distant metastatic disease
Who the study is looking for
- Adenocarcinoma of the prostate with intermediate risk disease T2b-T2c or Gleason score 7 or prostate specific antigen (PSA) 10-20 ng/ml, without metastatic disease
- To rule out metastatic disease, patients must have the following tests:
- Bone scan within 60 days prior to registration
- Computed tomography (CT) of abdomen/pelvis within 60 days prior to registration
- Karnofsky performance status \> 70
- Age \> 18
- PSA blood test within 60 days prior to registration
- Prostate biopsy within 180 days prior to registration
- Within 60 days prior to registration, hematologic minimal values:
- Absolute neutrophil count \> 1,500/mm\^3
- Hemoglobin \> 8.0 g/dl
- Platelet count \> 100,000/mm\^3
- Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
- No history of previous pelvic irradiation
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 |
|---|---|---|---|
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.