A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02254746|
Recruitment Status : Active, not recruiting
First Posted : October 2, 2014
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Adenocarcinoma||Radiation: Stereotactic Body Radiation Therapy (SBRT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Phase I (dose escalation)/ 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)
- 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.
- 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.
- 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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02254746
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, 1011|
|Principal Investigator:||Fernanda Herrera, MD||CHUV|