CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 116 enrolled
Drug / intervention
radiation therapyradiation
Likely dose
Conventional IMRT once daily, 5 days per week for approximately 7.5 weeksAI-extracted
Key inclusion· 6
  • Histologically confirmed prostate adenocarcinoma, clinical stage T1b–T2c
  • Pretreatment PSA ≤20 ng/mL
  • Gleason score ≤7
  • Suitable erectile function (IIEF Q1 score ≥2)
Key exclusion· 3
  • Prior pelvic radiotherapy
  • Prior or planned radical prostatectomy
  • Other active malignancy within 5 years (except nonmetastatic skin cancer or early-stage CLL)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00084552
NCT00084552N/ACompleted

Outcomes Following Intensity Modulated Radiation Therapy With And Without Erectile Tissue Dose Sparing For Favorable To Intermediate Risk Prostate Cancer

Fox Chase Cancer Center·interventional·Posted Jun 11, 2004·Updated Feb 25, 2021

In Brief

A clinical study evaluating radiation therapy for Prostate Cancer and 2 related conditions. Completed, enrolled 116 participants across 1 site.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) may reduce damage to healthy tissue near the tumor. It is not yet known whether reducing the dose of radiation to erectile tissue will help prevent erectile dysfunction. PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy alone to see how well it works compared to intensity-modulated radiation therapy with reduced doses to erectile tissue in treating patients with stage II prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 11, 2004
Enrollment StartDec 11, 2003
Primary CompletionAug 24, 2013
Study CompletionMay 5, 2016
TodayJul 2, 2026
Enrollment to primary: 9.7 yearsPosted 22.1 years ago

Interventions

radiation therapyradiation

Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.