CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 77 enrolled
Drug / intervention
< 15% risk of + LN +1 moreradiation
Likely dose
Proton therapy: 54 CGE over 30 treatments to prostate/SV (low LN-risk) or 45 Gy over 25 treatments to prostate/SV/LN (high LN-risk), followed by proton boost of 23.4-27 CGE or 32.4-36 CGE respectively over 13-20 treatments; concurrent low-dose docetaxel weekly during RT; adjuvant androgen deprivation therapy for 6 monthsAI-extracted
Key inclusion· 1
  • Histologically confirmed adenocarcinoma of the prostate
Key exclusion· 6
  • Prior prostate cancer treatment including chemotherapy and/or pelvic radiation
  • Active inflammatory bowel disease (diverticulitis, Crohn's disease, or ulcerative colitis) affecting the rectum
  • History of hip replacement
  • Prior intrapelvic surgery including transrectal/rectal surgery (except polypectomy, hemorrhoid removal/banding), transabdominal pelvic surgery, or bladder surgery

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

Search/NCT01040624
NCT01040624N/ACompleted

A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma

University of Florida·interventional·Posted Dec 29, 2009·Updated Oct 3, 2023

In Brief

A clinical study evaluating < 15% risk of + LN and > 15% risk of + LN for Prostate Cancer. Completed, enrolled 77 participants across 1 site.

Detailed Summary

The purpose of this study is to see what effects, good and/or bad, proton based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.

Study Details

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

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 29, 2009
Enrollment StartDec 1, 2009
Primary CompletionJan 1, 2015
Study CompletionApr 11, 2022
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 16.5 years ago

Interventions

< 15% risk of + LNradiation

Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months.

> 15% risk of + LNradiation

Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.