Adults 18 to 90, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB).Primary· 2 months
Feasibility of delivering stereotactic body radiotherapy(SBRT) with simultaneous integrated boost(SIB). The investigators will track the number of treatment plans(number of participants) for each dose level (37.5, 40, 42.5, or 45 Gy) that can be delivered while meeting radiation planning objectives.
Radiation dose - 37.5Gy
Group
Value
95% CI
Single Arm
9
Radiation Dose - 40.0Gy
Group
Value
95% CI
Single Arm
14
Radiation Dose - 42.5Gy
Group
Value
95% CI
Single Arm
2
Radiation Dose - 45Gy
Group
Value
95% CI
Single Arm
5
Number of Participants Who Received Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost (SIB) Without Greater Than Grade 3 GU/GI Toxicities.Primary· 1month
Group
Value
95% CI
Single Arm
30
Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients.Secondary· baseline, 3-6 months post treatment start
Health-related quality of life (HRQOL) measured using the Expanded Prostate Cancer Index Composite (EPIC) short-form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Baseline Urinary function
Group
Value
95% CI
Single Arm
87.9
45.3 – 100
Baseline Bowel Function
Group
Value
95% CI
Single Arm
93.1
50 – 100
Baseline Sexual function
Group
Value
95% CI
Single Arm
58.5
16.8 – 100
Baseline Hormonal Function
Group
Value
95% CI
Single Arm
90
80 – 100
3-6 months post - Urinary function
Group
Value
95% CI
Single Arm
93.1
52.8 – 100
3-6 months post - Bowel Function
Group
Value
95% CI
Single Arm
94.2
54.2 – 100
3-6 months post - Sexual Function
Group
Value
95% CI
Single Arm
53.3
12.5 – 100
3-6 months post - Hormonal Function
Group
Value
95% CI
Single Arm
82.8
80 – 100
American Urological Association (AUA) Questionnaire Will be Assessed.Secondary· baseline, 3-6 months post treatment start
Health-related quality of life (HRQOL) measured using the AUA assessment will occur at baseline, and at first follow up. The American Urological Association (AUA) has developed the following questionnaire to help men determine how bothersome their urinary symptoms are and to check how effective their treatment is. 0-7 is mild, 8-19 is moderate and 20-35 is severe.
Baseline
Group
Value
95% CI
Single Arm
6
1 – 14
3-6 month post RT
Group
Value
95% CI
Single Arm
6
1 – 13
Adverse events — posted to ClinicalTrials.gov
Time frame: The adverse events were collected over a time period of 6 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Weill Medical College of Cornell University
Last refreshed: 5 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03664193.