NCT00243321

Brief Summary

The principal objective of this study is to demonstrate that patients can safely receive combined High Dose Rate brachytherapy and Intensity-Modulated Radiation Therapy without experiencing a treatment limiting toxicity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2005

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

8.9 years

First QC Date

October 19, 2005

Last Update Submit

July 10, 2017

Conditions

Adenocarcinoma of the Prostate

Keywords

brachytherapyintensity-modulated radiation therapyprostate specific antigen

Outcome Measures

Primary Outcomes (1)

  • To demonstrate that patients can safely receive combined HDR brachytherapy and IMRT teletherapy to a total dose consistent with current treatment policies and without experiencing a treatment limiting toxicity

    10 years

Study Arms (1)

HDR brachytherapy -> IMRT

EXPERIMENTAL

Radiotherapy

Procedure: high dose-rate brachytherapyProcedure: intensity-modulated radiation therapy

Interventions

high dose-rate brachytherapyPROCEDURE

High dose-rate brachytherapy

HDR brachytherapy -> IMRT
intensity-modulated radiation therapyPROCEDURE

intensity-modulated radiation therapy

HDR brachytherapy -> IMRT

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • TRUS biopsy proven adenocarcinoma of the prostate Pretreatment PSA \<30 ng/ml Gleason's sum \< 8 clinical stage T1 or T2a,b. patients that are at low-intermediate risk for disease beyond the prostate normal liver function for all patients beginning hormone therapy Karnofsky Performance score \> 80 acceptable anesthesia risk as determined through routine pre-operative screening in the VCUHS Diagnostic Testing Clinic

You may not qualify if:

  • pubic-arch interference or regional disease ( no evidence of metastatic disease for patients whose PSA is greater than 10 ng/ml, Gleason's sum is greater than 6, or T-stage is greater than T2a.
  • Patients at high risk for distant disease (PSA \> 30 ng/ml, Gleason's sum \> 8 or clinical stage \> T2c), clinically involved seminal vesicles or extension beyond the prostate capsule history of inflammatory bowel disease require steroid or cytotoxic therapy for collagen vascular disease uncontrolled or poorly controlled hypertension uncontrolled or poorly controlled diabetes mellitus history of cancer other than skin cancer within five years of the initiation of protocol treatment history of pelvic irradiation require the routine use of warfarin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298-0058, United States

Location

Related Publications (1)

  • Amer AM, Mott J, Mackay RI, Williams PC, Livsey J, Logue JP, Hendry JH. Prediction of the benefits from dose-escalated hypofractionated intensity-modulated radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2003 May 1;56(1):199-207. doi: 10.1016/s0360-3016(03)00086-5.

    PMID: 12694839BACKGROUND

MeSH Terms

Interventions

Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Michael P Hagan, MD, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2005

First Posted

October 21, 2005

Study Start

February 1, 2003

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

US(1)