NCT02470897Completed
Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate Cancer
A Phase I/II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Simultaneous Integrated Boost and Urethral-Sparing IMRT Planning
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
This phase I/II trial studies the side effects and best dose of stereotactic body radiation therapy while using intensity-modulated radiation therapy (IMRT) planning to help avoid radiation to normal tissue in patients with prostate cancer. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using small, high doses of radiation over several days and may cause less damage to normal tissue. This treatment schedule allows for a higher dose of radiation to be administered over a shorter overall treatment period in comparison to standard radiation therapy.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 115 (actual)
- First submitted
- 10 Jun 2015
- Start date
- 24 Jul 2015
- Primary completion date
- 18 Aug 2025
- Lead sponsor
- University of Wisconsin, Madison
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT02470897
What you commit to
- Study type: Interventional
- Participants enrolled: 115
- From 24 Jul 2015 to the primary completion date, 18 Aug 2025
- 3 sites 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; (for example, carcinoma in situ of the bladder or oral cavity is permissible)
- Prosthetic implants in the pelvic region that the investigator feels will impede treatment, planning, or delivery (e.g., an artificial hip)
- =\< 3 months from a transurethral resection of the prostate (TURP) procedure
- Previous pelvic irradiation, prostate brachytherapy
- Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
Other illness
- Severe, active comorbidity, defined as follows:
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Crohn's disease or ulcerative colitis
- Scleroderma
Other
- For Arm A: Inability to obtain a planning MRI or a planning MRI of sufficient quality to allow identification of the peripheral zone and urethra, or inability to adequately fuse the MRI to the planning CT scan
- For both Arm A and Arm B:
- Significant urinary obstruction (i.e. AUA symptom score \> 18)
Who the study is looking for
- Histologically confirmed diagnosis of adenocarcinoma of the prostate and most recent biopsy within 180 days of study enrollment
- History/physical examination with digital rectal examination of the prostate within 90 days prior to study enrollment
- Gleason score =\< 7, no tertiary pattern \>= 5
- Clinical stage =\< T2b (American Joint Committee on Cancer (AJCC) 7th Edition Staging Manual) and no radiographic evidence of T3 or T4 disease
- Clinical stage N0, M0
- Most recent prostate specific antigen (PSA) within 60 days of enrollment
- Maximum PSA =\< 20 ng/ml (not within 20 days after biopsy)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- American Urological Association (AUA) =\< 18 with or without medical management
- Up to a total of year of androgen deprivation allowed.
- Participant signs study specific informed consent prior to study enrollment
Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UW Cancer Center Johnson Creek Coordinator of this site? Confirm its status | Johnson Creek | United States | Unknown status |
| University of Wisconsin Carbone Cancer Center Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Swedish American Coordinator of this site? Confirm its status | Rockford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.