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Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy With Temporary Iridium Implant Plus External Beam Radiation in Carcinoma of the Prostate

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Iridium Implant
Standard external beam irradiation
Sponsored by
Ontario Clinical Oncology Group (OCOG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Iridium, Implant, Radiotherapy

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients must have histologically proven adenocarcinoma of the prostate
  • The primary tumour should be staged clinically B2 or C as classified by A.J.C. Staging System

Exclusion Criteria:

  • Patients requiring transurethral prostatectomy (TURP) prior to diagnosis
  • Presence of metastases identified by bone scan, chest x-ray or CT scan of the abdomen and pelvis, or staging lymphadenectomy
  • Karnofsky performance status less than 80
  • Inadequate laboratory results: i.e. Hb < 12 gm/litre, WBC < 3.5 x 10 per litre, platelets < 100 x 10/litre, urea > 13 mmol/litre, creatinine > 220 mmol/litre
  • Unfit for surgery for other medical reasons
  • Age above 75 years
  • Failure to provide written informed consent

Sites / Locations

  • Juravinski Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Iridium implant plus external beam irradiation

Standard external beam irradiation alone

Outcomes

Primary Outcome Measures

Rate of local control as determined by biopsy at 18 months

Secondary Outcome Measures

Distant metastasis
Overall mortality
Mortality due to prostate cancer
Local complications of radiation

Full Information

First Posted
October 22, 2007
Last Updated
October 22, 2007
Sponsor
Ontario Clinical Oncology Group (OCOG)
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1. Study Identification

Unique Protocol Identification Number
NCT00548600
Brief Title
Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy With Temporary Iridium Implant Plus External Beam Radiation in Carcinoma of the Prostate
Official Title
A Randomized Clinical Trial Comparing Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy Using a Combination of a Temporaory Iridium Implant Plus External Beam Radiation in Surgically Staged B2 and C Carcinoma of the Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
May 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The specific objective of this study is to compare the relative efficacy of the combination of a temporary iridium implant plus external beam irradiation versus standard external beam irradiation alone in patients with Stage B2 and C prostatic carcinoma. Benefit will be assessed in terms of local recurrence, survival, and toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Iridium, Implant, Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Iridium implant plus external beam irradiation
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard external beam irradiation alone
Intervention Type
Procedure
Intervention Name(s)
Iridium Implant
Intervention Description
Temporary iridium implant of the prostate will be done and a dose of 3000 cGy will be delivered in the next 48-72 hours. Two weeks later 20 fractions of external beam radiation at a dose of 4000 cGy will be administered over a period of 4 weeks.
Intervention Type
Radiation
Intervention Name(s)
Standard external beam irradiation
Intervention Description
Standard external beam irradiation at a dose of 6400 cGy in 32 fractions over 6 and a half weeks will be administered.
Primary Outcome Measure Information:
Title
Rate of local control as determined by biopsy at 18 months
Time Frame
18-months
Secondary Outcome Measure Information:
Title
Distant metastasis
Time Frame
survival
Title
Overall mortality
Time Frame
survival
Title
Mortality due to prostate cancer
Time Frame
survival
Title
Local complications of radiation
Time Frame
2-5 years

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients must have histologically proven adenocarcinoma of the prostate The primary tumour should be staged clinically B2 or C as classified by A.J.C. Staging System Exclusion Criteria: Patients requiring transurethral prostatectomy (TURP) prior to diagnosis Presence of metastases identified by bone scan, chest x-ray or CT scan of the abdomen and pelvis, or staging lymphadenectomy Karnofsky performance status less than 80 Inadequate laboratory results: i.e. Hb < 12 gm/litre, WBC < 3.5 x 10 per litre, platelets < 100 x 10/litre, urea > 13 mmol/litre, creatinine > 220 mmol/litre Unfit for surgery for other medical reasons Age above 75 years Failure to provide written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinka Sathya, MD
Organizational Affiliation
Juravinski Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15718316
Citation
Sathya JR, Davis IR, Julian JA, Guo Q, Daya D, Dayes IS, Lukka HR, Levine M. Randomized trial comparing iridium implant plus external-beam radiation therapy with external-beam radiation therapy alone in node-negative locally advanced cancer of the prostate. J Clin Oncol. 2005 Feb 20;23(6):1192-9. doi: 10.1200/JCO.2005.06.154.
Results Reference
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Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy With Temporary Iridium Implant Plus External Beam Radiation in Carcinoma of the Prostate

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