CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr (PRO-SPEED)
CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr With Dose-escalation to the Dominant Intraprostatic Lesion: is the Juice Worth the Squeeze? The PRO-SPEED Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The patient to be enrolled in the prospective observational phase will be screened at first visit; prescription of Prostate Specific Antigen (PSA) and testosterone analysis, uroflowmetry and multiparametric Magnetic Resonance Imaging (mpMRI) are mandatory if not already done.
Additional staging imaging (computed tomography (CT) and/or bone scan) will be required according to National Comprehensive Cancer Network (NCCN) category risk group.
Subsequently, for the eligible patient, the enrollment phase involves eco-guided transrectal insertion of 3-4 gold fiducials in the prostate gland.
CT with full bladder and empty rectum will be done after 7-10 days from fiducials insertion; CyberKnife-Stereotactic Body Radiation Therapy (SBRT) treatment will start after 5-7 days from the simulation CT. A total of 36.25 Gy to the prostate gland will be executed in 5 alternate days. For each treatment delivery, the patient is required to be prepared in roughly the same bladder and rectum filling condition of the simulation day. Finally, in the last treatment day QoL and both clinician- and patient-reported genitourinary (GU) and gastrointestinal (GI) acute toxicity assessment is required.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Barbara Alicja Jereczek, MD
- Phone Number: +39 0257489037
- Email: barbara.jereczek@ieo.it
Study Locations
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-
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Milan, Italy
- Recruiting
- European Institute of Oncology
-
Contact:
- Barbara Alicja Jereczek
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 18 and < 80 years
- Histologically confirmed adenocarcinoma of the prostate
- Low, Intermediate and high-risk category according to NCCN version 02.2021
- Clinically node negative and no distant metastasis
- Eastern Cooperative Oncology Group (ECOG) Performance Status <2
- Good urinary flow (peak flow >10 mL/s) or IPSS < 15
- Prostate volume < 100 cc
- Available mpMRI of the prostate
- Less than 3 DILs at mpMRI (if >2 DILs, only DILs with higher Prostate Imaging - Reporting and Data System (PIRADS) will be included and only PI-RADS >2)
- Written informed consent for treatment and research purpose
Exclusion Criteria:
- platelets count < 75000
- urethral stricture
- Previous pelvic RT
- Concomitant inflammatory bowel disease or other serious systemic comorbidities
- Previous prostatectomy
- Presence of hip prosthesis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CyberKnife SBRT treatment
CyberKnife ultra-hypofractionated SBRT for localized Prostate cancer with dose-escalation to the dominant intraprostatic lesion
|
CyberKnife ultra-hypofractionated SBRT for localized Prostate cancer with dose-escalation to the dominant intraprostatic lesion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants with Acute GU and GI toxicities (RTOG)
Time Frame: 3 months
|
Evaluation of acute genitourinary and gastrointestinal toxicity using Radiation Toxicity Grading (RTOG) distinguishing between lower toxicities (G1 and G2) and worse toxicities (G3 and G4)
|
3 months
|
|
Number of Participants with Late GU and GI toxicities (RTOG)
Time Frame: 24 months
|
Evaluation of late genitourinary and gastrointestinal toxicity using Radiation Toxicity Grading (RTOG) distinguishing between lower toxicities (G1 and G2) and worse toxicities (G3 and G4)
|
24 months
|
|
Evaluation of patient-reported toxicity
Time Frame: 24 months
|
Evaluation of patient-reported toxicity using International Prostatic Symptoms Score IPSS
|
24 months
|
|
Evaluation of patient-reported quality of life
Time Frame: 24 months
|
Evaluation of patient-reported toxicity using International Index of Erectile Function Questionnaire
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barbara Alicja Jereczek, European Institute of Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IEO 1872
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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