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Clinical Trials in Canada / NCT01368588
Active, not recruiting Phase 3

Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

NCT01368588 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2011-07
Last updated
2026-05-08

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

three-dimensional conformal radiotherapyintensity modulated radiotherapyBrachytherapyAnti-androgenluteinizing hormone-releasing hormone (LHRH) agonist or antagonist

three-dimensional conformal radiotherapy: Daily fractions

intensity modulated radiotherapy: Daily fractions

Brachytherapy: Implant

Anti-androgen: Tablet

luteinizing hormone-releasing hormone (LHRH) agonist or antagonist: Injection

Study summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.

PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
DISEASE CHARACTERISTICS: Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence as determined by one of the following combinations: * Gleason score 7-10 + T1c-T2b (palpation) + PSA \< 50 ng/ml (includes intermediate and high risk patients); * Gleason score 6 + T2c-T4 (palpation) + PSA \< 50 ng/ml -ORGleason score 6 + ≥ 50% (positive) biopsies + PSA \< 50 ng/ml; * Gleason score 6 + T1c-T2b (palpation) + PSA \> 20 ng/ml. Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure. * History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration. * Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), (but not by nodal sampling, or dissection) within 90 days prior to registration. * Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm. \*No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (Na F PET/CT is an acceptable substitute). * Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis. \*Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration. * Study entry PSA should not be obtained during the following time frames: (1) 10- day period following prostate biopsy; (2) following initiation of hormonal therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride. * Zubrod Performance Status 0-1(unless otherwise specified); * Age ≥ 18; * CBC/differential obtained within 60 days prior to registration on study, with adequate bone marrow function defined as follows: * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; * Platelets ≥ 100,000 cells/mm3; * Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.); * Patient must be able to provide study specific informed consent prior to study entry.

Primary outcome measure(s)

Trial sites (478)

FacilityCityRegionStatus
University of South Alabama Mitchell Cancer Institute Mobile Alabama
Anchorage Associates in Radiation Medicine Anchorage Alaska
Alaska Oncology and Hematology LLC Anchorage Alaska
Anchorage Oncology Centre Anchorage Alaska
Katmai Oncology Group Anchorage Alaska
Providence Alaska Medical Center Anchorage Alaska
Fairbanks Memorial Hospital Fairbanks Alaska
Arizona Breast Cancer Specialists-Gilbert Gilbert Arizona
Arizona Center for Cancer Care-Peoria Peoria Arizona
Cancer Center at Saint Joseph's Phoenix Arizona
Saint Joseph's Hospital and Medical Center Phoenix Arizona
Arizona Breast Cancer Specialists-Phoenix Phoenix Arizona
Arizona Oncology-Deer Valley Center Phoenix Arizona
21st Century Oncology-Scottsdale Scottsdale Arizona
Arizona Breast Cancer Specialists Scottsdale Arizona
Arizona Breast Cancer Specialists-Scottsdale Scottsdale Arizona
Arizona Oncology Services Foundation Scottsdale Arizona
Arizona Center for Cancer Care-Surprise Surprise Arizona
Arizona Oncology Associates-West Orange Grove Tucson Arizona
University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona
Banner University Medical Center - Tucson Tucson Arizona
University of Arizona Cancer Center-North Campus Tucson Arizona
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
University of Arkansas for Medical Sciences Little Rock Arkansas
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
AIS Cancer Center at San Joaquin Community Hospital Bakersfield California
Alta Bates Summit Medical Center-Herrick Campus Berkeley California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
Mercy San Juan Medical Center Carmichael California
Adventist Health Cancer Care Center Chico Chico California
Fresno Cancer Center Fresno California
Saint Agnes Medical Center Fresno California
Marin General Hospital Greenbrae California
UC San Diego Moores Cancer Center La Jolla California
Tibor Rubin VA Medical Center Long Beach California
Los Angeles County-USC Medical Center Los Angeles California
USC / Norris Comprehensive Cancer Center Los Angeles California
Cedars Sinai Medical Center Los Angeles California

+ 438 more sites — see the full list on the official registry below.

More Radiation Therapy Oncology Group trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01368588 on ClinicalTrials.gov ↗ ← All trials in Canada