A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 63
Summary
- Conditions
- Prostate Adenocarcinoma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
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 pa...
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.
Tracking Information
- NCT #
- NCT02254746
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Fernanda Herrera, MD CHUV
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