This trial is active, not recruiting.

Condition prostate cancer
Treatment radiotherapy
Phase phase 1/phase 2
Sponsor University of Wisconsin, Madison
Collaborator National Cancer Institute (NCI)
Start date August 2002
End date August 2017
Trial size 309 participants
Trial identifier NCT00214097, NCI (P01 CA88960), RO02803


The purpose of this study is to examine the clinical feasibility of using 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
3 cohorts of dose escalations
Daily radiation to prescribed dose

Primary Outcomes

To evaluate acute and long term tolerances to dose-per-fraction escalation in the treatment of prostate cancer using optimized treatment of IMRT, daily rectal balloon displacement, and transabdominal ultrasound localization of the prostate
time frame: 90 days post radiation

Secondary Outcomes

Evaluate local tumor control and biochemical progression-free survival.
time frame: 90 days post radiation

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Prostate Cancer stage 2b or less, predicted risk of lymph node involvement less then 15%, Gleason <7, No distance mets Exclusion Criteria: - distant mets

Additional Information

Official title Phase I/II Trial Examining Dose-per-Fraction Escalation Using Intensity Modulated Radiation Therapy in the Treatment of Prostate Cancer
Principal investigator Mark Ritter, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.