A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer
Prostate Adenocarcinoma
Conditions: official terms
Adenocarcinoma - Prostatic Neoplasms
Study Type
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Stereotactic Body Radiation Therapy (SBRT)
Type: Radiation
Overall Status
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).

- To determine the feasibility of achieving dose constraints in the organs at risk using high technology radiotherapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 the following staging assessments: computed tomography (CT) scan (in case of PSA ≥ 20μg/mL, T3 tumor or Gleason Score ≥ 8), endorectal coil magnetic resonance image (MRI) of the prostatic gland before rectal spacer, bone scan (in case of PSA ≥ 20μg/mL, T3 tumor or Gleason Score ≥ 8).

- 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 registration in the trial
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Status: Recruiting
Start Date
September 2014
Completion Date
March 2018
Centre Hospitalier Universitaire Vaudois
Centre Hospitalier Universitaire Vaudois
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page