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Trial Title:
A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer
NCT ID:
NCT02254746
Condition:
Prostate Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic Body Radiation Therapy (SBRT)
Arm group label:
Phase I (dose escalation)/ Phase II
Summary:
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.
Detailed description:
Primary objective phase I:
To irradiate the prostate gland which might albeit contain microscopic disease with
tumoricidal doses of SBRT, and to escalate the dose of SBRT in the visible prostatic
tumor towards the best tumoricidal dose without exceeding the normal tissue tolerance and
toxicity in patients with organ confined T2-T3 N0 prostate carcinoma.
Primary objective phase II:
To determine the rate of acute toxicity grade 2 or more defined as toxicity occurring
immediately after the first fraction of radiotherapy and up to 90 days after the start of
radiotherapy treatment.
Secondary objectives phase II:
- To determine efficacy measured by PSA failure using Phoenix definition.
- To determine long-term late toxicity (>90 days after treatment start).
Exploratory endpoint phase II:
• To determine the feasibility of achieving dose constraints in the organs at risk using
high technology radiotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous radiotherapy in the pelvis
- Tumor localized at less than 3 mm from the urethra
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Universitaire Vaudois
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Start date:
September 2014
Completion date:
March 2024
Lead sponsor:
Agency:
Centre Hospitalier Universitaire Vaudois
Agency class:
Other
Source:
Centre Hospitalier Universitaire Vaudois
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02254746