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

Sponsored by:	Ontario Clinical Oncology Group (OCOG)
Information provided by:	Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:	NCT00548600

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Procedure: Iridium Implant Radiation: Standard external beam irradiation	Phase III

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:

Rate of local control as determined by biopsy at 18 months [ Time Frame: 18-months ]

Secondary Outcome Measures:

Distant metastasis [ Time Frame: survival ]
Overall mortality [ Time Frame: survival ]
Mortality due to prostate cancer [ Time Frame: survival ]
Local complications of radiation [ Time Frame: 2-5 years ]

Enrollment:	112
Study Start Date:	May 1992
Study Completion Date:	September 2006

Arms	Assigned Interventions
1: Experimental Iridium implant plus external beam irradiation	Procedure: 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.
2: Active Comparator Standard external beam irradiation alone	Radiation: 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.

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548600

Locations

Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2

Sponsors and Collaborators

Ontario Clinical Oncology Group (OCOG)

Investigators

Study Chair:

Jinka Sathya, MD

Juravinski Cancer Centre

More Information

Publications:

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.

Study ID Numbers:	OCOG-1992-Iridium
Study First Received:	October 22, 2007
Last Updated:	October 22, 2007
ClinicalTrials.gov Identifier:	NCT00548600 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):

Prostate Cancer
Iridium
Implant
Radiotherapy

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009