CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 129 enrolled
Drug / intervention
High Dose brachytherapy boost +1 moreradiation
Likely dose
High-dose-rate brachytherapy 19 Gy in two fractions (on day of placement and 6-24 hours later) plus external beam radiotherapy 45 Gy (1.8 Gy daily, five days a week for five weeks)AI-extracted
Key inclusion· 5
  • ✓Histologically confirmed prostate adenocarcinoma, clinical stage T1c-T3b, N0, M0
  • ✓Clinically negative nodes on imaging (CT or MRI)
  • ✓Zubrod performance status 0-1
  • ✓No prior pelvic or prostate radiation or chemotherapy for prostate cancer; induction hormonal therapy beginning ≤120 days prior to registration is acceptable
Key exclusion· 8
  • ✕Stage T4 disease
  • ✕Lymph node involvement (N1)
  • ✕Evidence of distant metastases (M1)
  • ✕Prior radical prostatectomy

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

Search/NCT00091390
NCT00091390Phase 2Completed
CompareCT.gov

Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate

Radiation Therapy Oncology Group·interventional·Posted Sep 9, 2004·Updated Aug 10, 2020

In Brief

A Phase 2 clinical trial evaluating High Dose brachytherapy boost and External beam radiotherapy for Prostate Cancer. Completed, enrolled 129 participants across 12 sites.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), NRG Oncology

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 9, 2004
Enrollment StartJul 1, 2004
Primary CompletionJan 1, 2008
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 21.8 years ago

Interventions

High Dose brachytherapy boostradiation

19 Gy in two fractions (on day of placement and 6-24 hours later) before or after external beam radiotherapy, such that all study treatment occurs within 8 weeks.

External beam radiotherapyradiation

45 Gy as 1.8 Gy five days a week for five weeks.