N/A N=30 Treatment

MRI-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost for Prostate Cancer

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03664193 ↗

Enrolled (actual)

Serious AEs

3.3%

Results posted

Jan 2021

Primary outcome: Primary: Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). — 9; 14; 2; 5 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SIBRT (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Weill Medical College of Cornell University
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB).	9; 14; 2; 5	—
PRIMARY Number of Participants Who Received Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost (SIB) Without Greater Than Grade 3 GU/GI Toxicities.	30	—
SECONDARY Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients.	87.9; 93.1; 58.5; 90; 93.1; 94.2	—
SECONDARY American Urological Association (AUA) Questionnaire Will be Assessed.	6; 6	—

Summary

Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity.

Eligibility Criteria

Inclusion Criteria

Biopsy-proven diagnosis of prostate adenocarcinoma
NCCN defined low-, intermediate- and high-risk prostate cancer
Age ≥ 18
Patient must have prostate MRI with a PIRADS 3-5 lesion or PSMA positron emission tomography (PET) with an avid intraprostatic lesion

Exclusion Criteria

History of prior pelvic radiation (external beam or brachytherapy)
Inability to undergo MRI
Patients with metastatic disease (other than pelvic lymph nodes) are ineligible for this study
American Urological Association (AUA) score >17 - AUA score >17

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03664193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.