Adjuvant Androgen Suppression Plus Radiation Therapy for High-Risk Localized Adenocarcinoma Prostate

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2009 by McGill University
Sponsor:
Collaborator:
Abbott
Information provided by:
McGill University
ClinicalTrials.gov Identifier:
NCT01255891
First received: December 7, 2010
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

To evaluate the efficacy of LHRH agonist with adjuvant pelvic radiation therapy in post radical prostatectomy patients with high risk pathological features for failure. To determine the freedom from biochemical (maintenance of a PSA less than nadir + 2 ng/ml) and clinical progression rate at 5 years.


Condition Intervention Phase
Adenocarcinoma of the Prostate
Radiation: Androgen suppression plus radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II Study of Adjuvant Androgen Suppression Plus Radiation Therapy for High-Risk Localized Adenocarcinoma of the Prostate

Further study details as provided by McGill University:

Primary Outcome Measures:
  • to determine the rate of local and distance failure at 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: January 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Adjuvant
Adjuvant suppression plus radiation therapy
Radiation: Androgen suppression plus radiation therapy
Adjuvant androgen suppression plus radiation therapy

Detailed Description:

Same as brief Summary

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx]), i.e. lymph node dissection is not required;
  2. Any type of radical prostatectomy will be permitted, including retropubic, perineal laparoscopic or robotically assisted. If performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator vs. extended lymph node dissection) should be noted. There is no time limit for the date of radical prostatectomy.
  3. A post-radical prostatectomy entry PSA of > 0 and < 1 ng/ml at least 6 weeks after prostatectomy and within 30 days of registration.
  4. One of the following pathologic/chemical classifications:

    • T3N0/Nx disease with or without positive surgical margin; or;
    • Gleason score of 8 or more;
    • Pre prostatectomy PSA > 20 ng/ml
  5. KPS > 70
  6. Age ≥ 18;
  7. No distant metastases, based upon the following minimum diagnostic workup:
  8. History/physical examination (including digital rectal exam) within 8 wks prior to registration;
  9. A CT scan or MRI of the abdomen and pelvis within 120 days prior to registration;
  10. Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis.
  11. Adequate bone marrow function, within 90 days prior to registration, defined as follows:

    • Platelets ≥ 100,000 cells/mm3 based upon CBC;
    • Hemoglobin ≥ 10.0 g/dl based upon CBC
    • AST or ALT < 2 x the upper limit of normal within 90 days prior to registration;
  12. Patients must sign a study-specific informed consent prior to study entry.

EXCLUSION CRITERIA:

  1. A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;
  2. N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥ 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is sampled and is negative;
  3. Androgen deprivation therapy started prior to prostatectomy for > 6 months duration;
  4. Androgen deprivation therapy started after prostatectomy and prior to registration;
  5. Prior pelvic radiotherapy;
  6. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the oral cavity is permissible);
  7. Severe, active co-morbidity, defined as follows:

    • History of inflammatory bowel disease;
    • History of hepatitis B or C; Blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis.
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
    • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; AST or ALT are required; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol.
    • Prior allergic reaction to the study drug(s) involved in this protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255891

Contacts
Contact: Tamim Niazi, Dr. 514-340-8248 tamim.niazi@mcgill.ca

Locations
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Beatrice Fournier, Ph.D.    514-340-8248    bfournier@jgh.mcgill.ca   
Principal Investigator: Tamim Niazi, MD         
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1Y6
Contact: Luis Souhami, MD    514-934-8040    luis.souhami@muhc.mcgill.ca   
Contact: Audrey Fernandes, Ph.D.    514-934-1934 ext 43128    audrey.fernandes@muhc.mcgill.ca   
Sub-Investigator: Luis Souhami, MD         
Sponsors and Collaborators
McGill University
Abbott
Investigators
Principal Investigator: Tamim Niazi, MD McGill University Department of Oncology
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tamim Niazi, Principal Investigator, McGill University Department of Oncology
ClinicalTrials.gov Identifier: NCT01255891     History of Changes
Other Study ID Numbers: McG 0913
Study First Received: December 7, 2010
Last Updated: December 7, 2010
Health Authority: Canada: Health Canada

Keywords provided by McGill University:
high risk localized adenocarcinoma of the prostate

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014