A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer


Condition: Prostate Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02254746

Sponsor: Centre Hospitalier Universitaire Vaudois

Eligibility:

  • Age: minimum 18 Years maximum 99 Years
  • Gender: All

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

View trial on ClinicalTrials.gov