N/A N=26 Treatment

Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer (RAD 1203)

Prostate Cancer · Prostate Adenocarcinoma · Radiation Toxicity · Sexual Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT01856855 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2023

Primary outcome: Primary: Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer — 22 number of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Stereotactic Body Radiation Therapy with Integrated Boost (Radiation)
Age: Adult, Older Adult · 19+ yrs
Sex: Male
Sponsor: John Fiveash, MD
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer	22	—
SECONDARY Treatment Planning Feasibility	26	—
SECONDARY Early Efficacy	26	—
SECONDARY Number of Patients Who Experienced Late Toxicity	22	—
SECONDARY Median Quality of Life Score	11; 17; 85.8; 57.7; 91.1	—

Summary

This study will investigate the safety, tolerability, and effectiveness of giving a higher dose to the part of the prostate which contains the cancer while giving a standard radiation dose to the entire prostate. The investigators have hypothesized that this treatment technique will effectively control the prostate cancer while minimizing the side effects.

Eligibility Criteria

Inclusion Criteria

All patients must have Histologically confirmed prostate adenocarcinoma, with biopsies obtained within twelve months of patient registration
NCCN risk category very low, low, or intermediate risk
Combined Gleason score 5 years
Risk of malignant lymph node involvement 60
Age > 19 years
Subjects given written informed consent

Exclusion Criteria

History of inflammatory bowel disease
Prior radical prostate surgery, transurethral resection of the prostate(TURP), or prostate cryotherapy
Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids are not considered an exclusion criteria.
Platelet count 120 cc as estimated by trans-rectal ultrasound at time of prostate biopsy (TRUS biopsy).
Risk of malignant lymph node involvement > 15% as calculated on Partin tables.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01856855). 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.