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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) Cancer and Leukemia Group B |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00567580 |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen deprivation therapy is more effective for prostate cancer.
PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: bicalutamide Drug: flutamide Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy |
Estimated Enrollment: | 1764 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
(Prostate bed radiotherapy [PBRT] alone): Patients undergo PBRT once daily, 5 days a week, Monday through Friday, for approximately 7-8 weeks (36 to 39 fractions).
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Procedure: radiation therapy
Once daily, 5 days a week
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Arm II: Experimental
(PBRT and short-term androgen deprivation [STAD]): Beginning 2 months before the start of PBRT, patients undergo short term androgen deprivation (STAD), using a combination of antiandrogen and luteinizing hormone-releasing hormone (LHRH) agonist therapy, for a total of 4-6 months. Patients receive antiandrogen therapy comprising either oral flutamide 3 times daily or oral bicalutamide once daily for at least 4 months. Patients receive LHRH agonist injection beginning concurrently with or 2 weeks after the start of antiandrogen therapy. LHRH agonist injection consist of analogs (e.g., leuprolide, goserelin, buserelin, or triptorelin) and may be given as a 1-monthly, 3-monthly, 4-monthly, or 6- monthly injection or in any combination. Total LHRH agonist treatment time is 4-6 months. Approximately 2 months after beginning of STAD, patients undergo PBRT as in arm I.
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Drug: bicalutamide
Oral, daily
Drug: flutamide
Oral, daily
Procedure: radiation therapy
Once daily, 5 days a week
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Arm III: Experimental
(Pelvic lymph node radiotherapy [PLNRT], PBRT, and STAD): Beginning 2 months before the start of radiotherapy, patients receive STAD therapy as in arm II. Approximately 2 months after beginning of STAD, patients undergo PBRT and PLNRT once daily, 5 days a week, Monday through Friday, for approximately 5 weeks (25 fractions) followed by PBRT only once daily, 5 days a week for approximately 2-3 weeks (11-14 fractions).
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Drug: bicalutamide
Oral, daily
Drug: flutamide
Oral, daily
Procedure: radiation therapy
Once daily, 5 days a week
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Adenocarcinoma of the prostate treated primarily with radical prostatectomy
Meets 1 of the following pathologic classifications:
PATIENT CHARACTERISTICS:
No severe, active co-morbidity, including any of the following:
Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
PRIOR CONCURRENT THERAPY:
Study Chair: | Alan Pollack, MD, PhD | Fox Chase Cancer Center |
Investigator: | Leonard G. Gomella, MD | Jefferson Medical College of Thomas Jefferson University |
Study Chair: | Joycelyn L. Speight, MD, PhD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000577574, RTOG-0534 |
Study First Received: | December 4, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00567580 |
Health Authority: | Unspecified |
stage II prostate cancer stage III prostate cancer adenocarcinoma of the prostate |
Prostatic Diseases Genital Neoplasms, Male Bicalutamide Urogenital Neoplasms |
Flutamide Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Androgen Antagonists Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses |
Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions |