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

Primary Purpose

Prostate Adenocarcinoma

Status

Active

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Stereotactic Body Radiation Therapy (SBRT)

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phase I (dose escalation)/ Phase II

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Toxicity (phase II)

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

Secondary Outcome Measures

Efficacy (phase II)

PSA failure using Phoenix definition

Toxicity (phase II)

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

Full Information

NCT ID

NCT02254746

First Posted

September 16, 2014

Last Updated

August 9, 2021

Sponsor

Centre Hospitalier Universitaire Vaudois

1. Study Identification

Unique Protocol Identification Number

NCT02254746

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 2014 (undefined)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase I (dose escalation)/ Phase II

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy (SBRT)

Primary Outcome Measure Information:

Title

Maximum tolerated dose (phase I)

Description

Time Frame

During the first 30 days from the start of treatment

Title

Toxicity (phase II)

Description

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

Time Frame

90 days after the first fraction of radiotherapy treatment

Secondary Outcome Measure Information:

Title

Efficacy (phase II)

Description

PSA failure using Phoenix definition

Time Frame

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

Title

Toxicity (phase II)

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernanda Herrera, MD

Organizational Affiliation

CHUV

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Universitaire Vaudois

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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