NCT02254746Completed
A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer
Source: ClinicalTrials.gov · Last updated 14 Feb 2025
Brief summary (registry, in English)
The aim of this study is to test the safety and efficacy of Stereotactic Body Radiation Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment is the irradiation of the entire prostate gland with or without seminal vesicles accompanied or not by hormonal therapy. In light of the accumulating clinical evidence favoring the use of hypo fractionation, SBRT regimen might constitute a much more convenient non-invasive and highly efficient outpatient therapy.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 16 Sept 2014
- Start date
- Aug 2014
- Primary completion date
- Apr 2017
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Diseases
- Prostate cancer
- NCT number
- NCT02254746
What you commit to
- Study type: Interventional
- Participants enrolled: 27
- From Aug 2014 to the primary completion date, Apr 2017
- 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
- Previous radiotherapy in the pelvis
Other illness
- History of inflammatory colitis (including Crohn's disease and ulcerative colitis)
- Prior cancer in the pelvis
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before inclusion in the trial
Other
- Tumor localized at less than 3 mm from the urethra
Who the study is looking for
- All patients must be willing and capable to provide informed consent
- Histologic confirmation of prostate adenocarcinoma
- T2-T3 tumors, N0 (clinically by no evidence of metastatic lymph nodes on CT or MRI)
- No direct evidence of regional or distant metastases
- PSA less than or equal to 50 μg/ml
- Visible gross tumor at the prostate endorectal coil MRI.
- The ultrasound or MRI based volume estimation of the patient's prostate gland no greater than 70g or 70cc
- No significant urinary obstructive symptoms; IPSS score must be ≤ 15 (alpha blockers allowed)
- Patient must have undergone an endorectal coil magnetic resonance image (MRI) of the prostatic gland (before rectal spacer if any),
- Patient must have undergone the following assessments in case of PSA ≥ 20μg/L, and/or T3 tumor and/or Gleason Score ≥ 8:
- bone scan
- Chest abdominal and pelvis computed tomography (CT) scan
- If tumor is localized at less than 3 mm from the rectum a rectal spacer is mandatory. Patient accepts the rectal spacer to be injected before treatment starts
- Patient accepts to have one planning MRI after the injection of rectal spacer (without endorectal coil)
- Patient accepts the preparation of the bladder (bladder full), before the planning MRI, planning CT and then before each treatment fraction
Age in the registry: 18 years to 99 years · Sex: All · 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 |
|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.