18 and older, 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.
Number of Participants Who Experience Grade 3 or Higher Acute ToxicitiesPrimary· 90 days post radiation treatment
To evaluate acute tolerances to dose-per-fraction escalation in the treatment of prostate cancer using optimized treatment of Intensity-modulated radiation therapy (IMRT), daily rectal balloon displacement, and transabdominal ultrasound localization of the prostate. For toxicities observed within the first 10 patients at each hypofractionation level, ≥20% acute grade 3 or higher GI or genitourinary (GU) toxicity will constitute a threshold toxicity level and will dictate a decrease in frequency of treatment by one treatment per week. Maximum tolerated dose is reached if 20% of participants exp
Group
Value
95% CI
Level 1
1
Level 2
1
Level 3
0
Number of Subjects Experiencing Grade 2 or Higher Late Rectal Toxicities at Any Time During Follow UpPrimary· from 90 days post XRT through last follow-up visit (up to 3 years)
To evaluate late radiation toxicities to dose-per fraction escalation in the treatment of prostate
Group
Value
95% CI
Level I
14
Level II
26
Level III
29
Biochemical Progression-free Survival Based on PSA SurveillanceSecondary· up to 15 years from enrollment
Patients will be considered to be without biochemical recurrence if either the Prostate-specific antigen (PSA) is still declining or the PSA nadir has been reached and is below 1.0ng/ml
Group
Value
95% CI
Level I
91.5
88.2 – 94.8
Level II
92.7
90 – 95.4
Level III
94.1
91.9 – 96.3
Fox Chase Bowel Survey at Baseline and 3 YearsSecondary· Baseline and 3 years
The Fox Chase Bowel/Bladder survey was divided into two sections: Bowel (questions 1 to 14, N=14) and Bladder (questions 19, and 21 to 30, N=11). To facilitate analysis, Bowel and Bladder scores for each section were rescaled to a total score of between 0 - 100, where higher scores indicated better Quality of Life (QoL). Results for the Bowel Section are reported here.
Baseline
Group
Value
95% CI
Level I
90.0
± 10.7
Level II
88.0
± 14.6
Level III
86.2
± 14.6
Year 3
Group
Value
95% CI
Level I
86.3
± 11.1
Level II
87.7
± 11.6
Level III
85.4
± 14.7
Fox Chase Bladder Survey at Baseline and 3 YearsSecondary· Baseline and 3 years
The Fox Chase Bowel/Bladder survey was divided into two sections: Bowel (questions 1 to 14, N=14) and Bladder (questions 19, and 21 to 30, N=11). To facilitate analysis, Bowel and Bladder scores for each section were rescaled to a total score of between 0 - 100, where higher scores indicated better Quality of Life. Results for the Bladder Section are reported here.
Baseline
Group
Value
95% CI
Level I
84.2
± 9.4
Level II
84.7
± 10.1
Level III
82.7
± 11.3
3 years
Group
Value
95% CI
Level I
79.5
± 13.5
Level II
82.5
± 10.1
Level III
81.1
± 12.2
International Index of Erectile Function (IIEF) Score at Baseline and 3 YearsSecondary· Baseline and 3 years
The IIEF is a 15-item survey where 9-items are scored 0-5 and 6-items are scored 1-5 with a total range of 6-75. The standard scoring mechanism was used for IIEF, where the QoL items corresponded to the following domains: erectile function (score range 1-30), orgasmic function (score range 1-10), sexual desire (score range 2-10), intercourse satisfaction (score range 0-15), and overall satisfaction (score range 2-10). Higher numbers indicate increased QoL.
Baseline
Group
Value
95% CI
Level I
15.6
± 11.7
Level II
17.6
± 11.7
Level III
15.1
± 11.1
3 years
Group
Value
95% CI
Level I
10.4
± 10.6
Level II
13.6
± 11.7
Level III
9.6
± 8.9
Spritzer Quality of Life Index (SQLI) at Baseline and 3 YearsSecondary· Baseline and 3 years
The SQLI is composed of five items (activity, daily living, health, support, outlook) scored utilizing a numerical scale of 0-2. Standard scoring was also used for the SQLI survey (total score range 0-10) where higher score indicate increased QoL.
Baseline
Group
Value
95% CI
Level I
9.7
± 0.7
Level II
9.4
± 1.2
Level III
9.5
± 1.4
Year 3
Group
Value
95% CI
Level I
9.5
± 1.4
Level II
9.8
± 0.4
Level III
9.5
± 1.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Acute GI and GU toxicities and Late GI and GU toxicities were recorded for the duration of the study. For level 1 patients, median followup was 100 months, for level 2 patients median follow up was 85.5 months and for level 3 it was 61.7 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. Progressively larger fraction sizes will be delivered in a phase I design based on both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects, while predicting that tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if proven effective and safe, would result in significant cost saving and more efficient use of resources. Phase II will commence with Maximum Tolerated Dose (MTD) finding with up to 200 additional patients being enrolled during this phase of the study.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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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 University of Wisconsin, Madison
Last refreshed: 25 November 2019
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/NCT00214097.