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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00936390 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: bicalutamide Drug: buserelin Drug: flutamide Drug: goserelin acetate Drug: leuprolide acetate Drug: triptorelin Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer |
| Estimated Enrollment: | 1520 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients undergo external-beam radiation therapy (EBRT) once daily on days 1-5. Some patients instead receive EBRT with high-dose rate or low-dose rate brachytherapy implant.
|
Radiation: 3-dimensional conformal radiation therapy
Given as external-beam radiation therapy
Radiation: intensity-modulated radiation therapy
Given as external-beam radiation therapy
|
|
Experimental: Arm II
Patients receive androgen-deprivation therapy comprising luteinizing-hormone releasing-hormone (LHRH) agonist (leuprolide, goserelin, buserelin, or triptorelin) subcutaneously or as an injection every 1 to 3 months AND an oral antiandrogen therapy (flutamide 3 times daily or bicalutamide once daily) for 6 months. Beginning 8 weeks after the first LHRH injection, patients undergo radiotherapy as in arm I.
|
Drug: bicalutamide
Given orally
Drug: buserelin
Given subcutaneously or as an injection
Drug: flutamide
Given orally
Drug: goserelin acetate
Given subcutaneously or as an injection
Drug: leuprolide acetate
Given subcutaneously or as an injection
Drug: triptorelin
Given subcutaneously or as an injection
Radiation: 3-dimensional conformal radiation therapy
Given as external-beam radiation therapy
Radiation: intensity-modulated radiation therapy
Given as external-beam radiation therapy
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of radiotherapy. Patients are stratified according to number of risk factors (1 vs 2-3), comorbidity (ACE-27 grade ≥ 2 vs < 2), and radiotherapy (RT) modality (dose-escalated external-beam RT [EBRT] vs EBRT and low-dose rate brachytherapy boost vs EBRT and high-dose rate brachytherapy boost). Patients are randomized to 1 of 2 treatment arms.
After completion of study therapy, patients are followed up periodically.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate diagnosed within the past 6 months and at intermediate-risk for recurrence by meeting ≥ 1 of the following criteria:
PSA > 10 and ≤ 20 ng/mL
Patients with Gleason Score ≥ 8, PSA > 20 ng/mL, OR clinical stage ≥ T3 are ineligible for this trial
No patients with all 3 intermediate-risk factors who also have ≥ 50% of the number of their biopsy cores positive for cancer
Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT scan or MRI), nodal sampling, or dissection within the past 60 days (required for patients with 2-3 risk factors)
No evidence of bone metastases on bone scan within the past 60 days
PATIENT CHARACTERISTICS:
No invasive malignancy or hematological malignancy (e.g., leukemia, lymphoma, myeloma) within the past 5 years except adequately treated non-melanomatous skin cancer
No severe or active co-morbidity with any of the following:
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
AIDS based upon current CDC definition
PRIOR CONCURRENT THERAPY:
No prior or concurrent cytotoxic chemotherapy for prostate cancer
No prior radiotherapy (RT), including brachytherapy, to the region of the study cancer that would result in overlap of RT fields
Contacts and Locations
Show 249 Study Locations| Study Chair: | Alvaro A. Martinez, MD, FACR | William Beaumont Hospital - Royal Oak Campus |
More Information
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00936390 History of Changes |
| Other Study ID Numbers: | CDR0000648194, RTOG-0815 |
| Study First Received: | July 8, 2009 |
| Last Updated: | May 23, 2012 |
| Health Authority: | Unspecified |
|
adenocarcinoma of the prostate stage IIB prostate cancer stage IIA prostate cancer |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Androgens Buserelin Leuprolide Triptorelin Flutamide Goserelin Bicalutamide Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Fertility Agents, Female Fertility Agents Reproductive Control Agents Therapeutic Uses Antineoplastic Agents, Hormonal Antineoplastic Agents Androgen Antagonists Hormone Antagonists Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents |