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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02254746
Recruitment Status : Active, not recruiting
First Posted : October 2, 2014
Last Update Posted : May 7, 2019
Information provided by (Responsible Party):
Dr Fernanda Herrera, Centre Hospitalier Universitaire Vaudois

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Radiation: Stereotactic Body Radiation Therapy (SBRT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer
Study Start Date : September 2014
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Phase I (dose escalation)/ Phase II

Phase I

  • Prostate tumor: starting dose 9 Gy per fraction in 5 fractions (total 45 Gy) and subsequent dose escalation up to 10 Gy.
  • Prostate gland: fixed prophylactic tumoricidal dose 7.25 Gy per fraction in 5 fractions (no dose escalation). Total 36.25 Gy.

Phase II

Additional patients will be treated at either the maximum tolerated dose (MTD) or at the highest dose level as determined by the investigators from the Phase I portion of the study.

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Primary Outcome Measures :
  1. Maximum tolerated dose (phase I) [ Time Frame: During the first 30 days from the start of treatment ]
    Observation of dose-limiting toxicities (DLT) defined as any treatment-related grade ≥ 3 acute toxicity occurring in the radiation field or irradiated volumes in the following categories GI or GU. In addition, any other grade 4 or 5 toxicity attributed to the therapy constitutes a DLT.

  2. Toxicity (phase II) [ Time Frame: 90 days after the first fraction of radiotherapy treatment ]
    Acute GU and GI toxicity (grade 2 or more) according to the NCI CTCAE v4.0.

Secondary Outcome Measures :
  1. Efficacy (phase II) [ Time Frame: 3 monthly assessments during the first 2 years and 6 monthly assessments until end of study (5 years) ]
    PSA failure using Phoenix definition

  2. Toxicity (phase II) [ Time Frame: > 90 days and up to 5 years from the start of protocol treatment ]
    Long term GU and GI toxicity (grade 2 or more) according to the NCI CTCAE v4.0.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02254746

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Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
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Principal Investigator: Fernanda Herrera, MD CHUV
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Responsible Party: Dr Fernanda Herrera, Cheffe de clinique, Centre Hospitalier Universitaire Vaudois Identifier: NCT02254746    
Other Study ID Numbers: CHUV-DO-HYPORT-2013
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type