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Trial record 1 of 1 for:    NCT00223145
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Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy Alone (PCS III)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00223145
First Posted: September 22, 2005
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Abdenour Nabid, Université de Sherbrooke
  Purpose
The hypothesis of the proposed study would be that, due to the six months of total androgen blockade, which would include neoadjuvant hormonal therapy for four months and concomitant hormonal therapy for two months with irradiation, the investigators could reduce local failure rates for these two dosage levels, namely 70 Gy and 76 Gy. Since increasing the dose to the prostate also seems to reduce local relapse rates, the results of the two hormonal therapy groups would be compared with the results of prostate irradiation at doses of 76 Gy. This study would verify the possibility of compensating a six Gy dosage increase of radiation therapy with six months of hormonal therapy between the 70 Gy and 76 Gy groups who received hormonal therapy, and also match these results with a dose escalation to the prostate of 76 Gy. In the future, this could result in more therapeutic choices, such as reducing the doses of radiation therapy and, consequently, its related complications, if hormonal therapy proves to be beneficial; or rather, to continue in the direction of dose escalation for this intermediate-risk patient group, everything being correlated to the side effects of hormonal therapy and irradiation.

Condition Intervention Phase
Prostate Cancer Radiation: Radiotherapy 70 Gy Radiation: Radiotherapy 76 Gy Drug: Androgen blockade Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Multicentre, Phase III Study in Patients With Intermediate-risk T1 T2 Prostate Adenocarcinomas, to Verify the Role of Six Months of Total Androgen Blockade for Two Dosage Levels of Prostate Radiation Therapy (70 Gy and 76 Gy) Versus Prostate Radiation Therapy Alone at 76 Gy

Resource links provided by NLM:


Further study details as provided by Abdenour Nabid, Université de Sherbrooke:

Primary Outcome Measures:
  • Interval before biochemical failure [ Time Frame: 10 years ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 10 years ]
  • Survival [ Time Frame: 10 years ]

Enrollment: 600
Study Start Date: December 2000
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Androgen blockade for 6 months + Radiotherapy 70 Gy
Radiation: Radiotherapy 70 Gy
Radiotherapy to the prostate
Drug: Androgen blockade
Duration : 6 months
Other Names:
  • Bicalutamide 50 mg
  • Goserelin 10.8 mg
Experimental: Arm 2
Androgen blockade for 6 months + Radiotherapy 76 Gy
Radiation: Radiotherapy 76 Gy
Radiotherapy to the prostate
Drug: Androgen blockade
Duration : 6 months
Other Names:
  • Bicalutamide 50 mg
  • Goserelin 10.8 mg
Active Comparator: Arm 3
Radiotherapy alone with 76 Gy
Radiation: Radiotherapy 76 Gy
Radiotherapy to the prostate

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is less than or equal to 6, as well as a prostate-specific antigen (PSA) between 10-20 (intermediate risk) or patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is equal to 7, as well as a PSA equal to or less than 20 (intermediate risk).
  • Performance status score of 0-1
  • Patients must sign a consent form before starting the study.
  • No evidence of regional disease
  • Patients with a previous history of cancer are eligible on the condition that they have been disease-free for more than five years.
  • Non-invasive epidermoid cancers of the skin are eligible.
  • The patient must be available for treatments and follow-up visits.
  • No evidence of metastatic disease, confirmed by a negative bone scan.

Exclusion Criteria:

  • Severe medical or psychiatric problems that may compromise study compliance
  • Chronic hepatic disease; abnormal hepatic function, i.e. aspartate aminotransferase and alanine aminotransferase > 1.5 times the upper normal limit.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223145


Locations
Canada, Quebec
Centre de Recherche Clinique du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Abdenour Nabid
AstraZeneca
Investigators
Principal Investigator: Abdenour Nabid, MD CRC - CHUS
  More Information

Responsible Party: Abdenour Nabid, Principal Investigator, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT00223145     History of Changes
Other Study ID Numbers: DC-990-0049,1
DC-990-0049
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by Abdenour Nabid, Université de Sherbrooke:
Prostate adenocarcinoma
Gleason score <= 6 and PSA 10-20
Gleason score = 7 and PSA <=20

Additional relevant MeSH terms:
Androgens
Bicalutamide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents


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