Status:
ACTIVE_NOT_RECRUITING
Phase II Study of Pencil Beam Scanning Proton Stereotactic Body Radiation Therapy for Prostate Cancer
Lead Sponsor:
The New York Proton Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This is a single arm phase II study of image-guided pencil beam scanning proton SBRT (40Gy RBE in 5 fractions delivered every other day) for patients with low- and intermediate-risk prostate cancer. T...
Eligibility Criteria
Inclusion
- Biopsy-proven NCCN low- or intermediate-risk prostate cancer, which includes patients with:
- Gleason score ≤7 disease
- PSA ≤20 ng/ml
- Clinical T1-T2c disease
- Note: Patients who only have radiographic evidence of possible or probable T3 disease (i.e., extracapsular extension or seminal vesical invasion) will not be excluded.
- KPS ≥ 80%
- Prostate size as determined on MRI to be \< 100 cc. Prostate size can be determined on CT scan if MRI is not available.
- Male 18 years of age or older
- IPSS ≤ 20
- Patient must be a candidate for and agree to placement of intraprostatic fiducial markers and a hydrogel rectal spacer
- Patient must be available for at least 2 years of follow-up
Exclusion
- Prior prostate surgery (including cryosurgery)
- Note: Patients who underwent TURP or greenlight PVP are eligible if it was \> 12 weeks prior to the anticipated start date of SBRT
- Prior history of chronic prostatitis or urethral stricture
- Currently active cancer(s) other than non-melanoma skin cancers. Patients are not considered to have currently active cancers if they have completed therapy and are considered by their physicians to be at \<5% risk of relapse within 2 years.
- Life expectancy of \< 2 years
Key Trial Info
Start Date :
January 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2031
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04842890
Start Date
January 8 2021
End Date
January 1 2031
Last Update
December 17 2024
Active Locations (1)
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1
The New York Proton Center
New York, New York, United States, 10035