NCT00915122

Brief Summary

The purpose of this study is to determine the feasibility and late toxicity of dose escalated radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the treatment of high risk prostate cancer. All eligible patients with high risk prostate cancer who are going to have primary radiation therapy to the pelvic lymph nodes and prostate seminal vesicles with or without concurrent hormonal therapy will be approached regarding study entry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_1

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

November 1, 2005

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
13.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2023

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

4.8 years

First QC Date

June 2, 2009

Last Update Submit

December 5, 2023

Conditions

Adenocarcinoma of the Prostate

Keywords

IMRT treatment for Prostate cancer patientsRadiation treatment for prostate cancercancer of the prostatePatients with high risk adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

  • Determine the feasibility and late toxicity of dose escalated radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the treatment of high risk prostate cancer.

    after all patients have completed study intervention

Secondary Outcomes (1)

  • acute toxicity of therapy;prostate motion when pelvic radiotherapy is delivered;treatment time required to deliver IMRT to the pelvic lymph nodes, prostate and seminal vesicles

    after all patients have completed study intervention

Study Arms (1)

IMRT in prostate cancer

EXPERIMENTAL
Radiation: Dose Escalated IMRT

Interventions

Dose Escalated IMRTRADIATION

Patients will receive external beam RT 55.1Gy in 29 once daily fractions to pelvic lymph nodes/prostate/seminal vesicles followed by 24.7Gy in 13 once daily fractions to the prostate/seminal vesicles using intensity modulated radiation therapy.

IMRT in prostate cancer

Eligibility Criteria

AgeUp to 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A histologic diagnosis of adenocarcinoma of the prostate within six months of entry.
  • Clinical Stage T1-T2 with (PSA \>20 or Gleason score \>7)
  • Clinical Stage T3, T4
  • Bone scan reported as negative for metastases within 6 months of study entry.
  • All patients must have a CT scan of the abdomen and pelvis reported as negative for nodal metastases within 12 wks of study entry.
  • The patient must not have received greater than 6 months of hormonal therapy.
  • The patient must not have received cytotoxic anticancer therapy prior to study entry.
  • Patients must have an ECOG performance status of 2 or less.
  • Age 80 years old or less
  • Signed informed consent

You may not qualify if:

  • Patients with history of inflammatory bowel disease or other contraindication to radical radiation therapy
  • Patients with prior colorectal surgery
  • Patients with prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • Bayley A, Rosewall T, Craig T, Bristow R, Chung P, Gospodarowicz M, Menard C, Milosevic M, Warde P, Catton C. Clinical application of high-dose, image-guided intensity-modulated radiotherapy in high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):477-83. doi: 10.1016/j.ijrobp.2009.05.006. Epub 2009 Sep 3.

    PMID: 19733014BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Tara Rosewell, MD

    University Health Network, Princess Margaret Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 5, 2009

Study Start

November 1, 2005

Primary Completion

September 1, 2010

Study Completion

October 24, 2023

Last Updated

December 6, 2023

Record last verified: 2023-12

Locations

CA(1)