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

NCT02254746 | Completed DMC

• 1 other identifier: CHUV-DO-HYPORT-2013
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (phase I)

  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.

  During the first 30 days from the start of treatment

• Toxicity (phase II)

  Acute GU and GI toxicity (grade 2 or more) according to the NCI CTCAE v4.0.

  90 days after the first fraction of radiotherapy treatment

Secondary Outcomes (2)

• Efficacy (phase II)

  3 monthly assessments during the first 2 years and 6 monthly assessments until end of study (5 years)

• Toxicity (phase II)

  > 90 days and up to 5 years from the start of protocol treatment

Study Arms (1)

Phase I (dose escalation)/ Phase II

EXPERIMENTAL

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)

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

Phase I (dose escalation)/ Phase II

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Fernanda Herrera, MD

  CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cheffe de clinique

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: October 2, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: November 8, 2023
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)