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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

NCT ID: NCT00548600

Last Updated: 2007-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-05-31

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Prostate Cancer Iridium Implant Radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Iridium implant plus external beam irradiation

Group Type EXPERIMENTAL

Iridium Implant

Intervention Type PROCEDURE

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.

2

Standard external beam irradiation alone

Group Type ACTIVE_COMPARATOR

Standard external beam irradiation

Intervention Type RADIATION

Standard external beam irradiation at a dose of 6400 cGy in 32 fractions over 6 and a half weeks will be administered.

Interventions

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Iridium Implant

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 PROCEDURE

Standard external beam irradiation

Standard external beam irradiation at a dose of 6400 cGy in 32 fractions over 6 and a half weeks will be administered.

Intervention Type RADIATION

Eligibility Criteria

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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
Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role lead

Principal Investigators

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Jinka Sathya, MD

Role: STUDY_CHAIR

Juravinski Cancer Centre

Locations

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Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 15718316 (View on PubMed)

Other Identifiers

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OCOG-1992-Iridium

Identifier Type: -

Identifier Source: org_study_id