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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

Overall Recruitment Status: Enrollment complete

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

Region

Sponsors

California - Northern

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Acronym

NCT No.

NCT00567580

Study Type

Phase

INTERVENTIONAL

Phase III

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.

Detailed Description

OBJECTIVES: Primary To determine whether the addition of short-term androgen deprivation (STAD) to prostate bed radiotherapy (PBRT) improves freedom from progression (FFP) (i.e., maintenance of a prostate-specific antigen [PSA] less than the nadir+2 ng/mL, absence of clinical failure, and absence of death from any cause) for 5 years, over that of PBRT alone in men treated with salvage radiotherapy after radical prostatectomy. To determine whether STAD, pelvic lymph node radiotherapy (PLNRT), and PBRT improves FFP over that of STAD+PBRT and PBRT alone in men treated with salvage radiotherapy after radical prostatectomy

Inclusion Criteria

Zubrod performance status 0-1

Platelets >= 100,000/mm^3

Hemoglobin >= 10.0 g/dL (the use of transfusion or other intervention to achieve this is allowed)

Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x upper limit of normal

A post-radical prostatectomy entry PSA of >= 0.1 and <= 1.0 ng/mL at least 6 weeks after prostatectomy and within 30 days of registration

Serum total testosterone >= 40% of the lower limit of normal (patients who have had a unilateral orchiectomy are eligible as long as this requirement is met)

Exclusion Criteria

Neoadjuvant chemotherapy before or after prostatectomy

Prior cryosurgery or brachytherapy of the prostate (prostatectomy should be the primary treatment and not a salvage procedure)

Prior pelvic radiotherapy

Prior allergic reaction to the study drug(s) involved in this protocol

Prior invasive malignancy (except nonmelanoma skin cancer) or superficial bladder cancer unless disease free for a minimum of 5 years (e.g., carcinoma in situ of the oral cavity is permissible)

Keywords and/or Specific Medical Conditions

adenocarcinoma of the prostate	Neoplasms by Site
Androgen Antagonists	Pharmacologic Actions
Androgens	Physiological Effects of Drugs
Antineoplastic Agents	Prostatic Diseases
Antineoplastic Agents, Hormonal	Prostatic Neoplasms
Bicalutamide	RTOG-0534
Flutamide	stage IIA prostate cancer
Genital Diseases, Male	stage IIB prostate cancer
Genital Neoplasms, Male	stage III prostate cancer
Hormone Antagonists	Therapeutic Uses
Hormones	Urogenital Neoplasms
Hormones, Hormone Substitutes, and Hormone Antagonists	Oncology (Adult)
Neoplasms

KP Clinical Facility

Central Valley-Modesto
Central Valley-Stockton
Diablo Medical Center-Walnut Creek
Fremont Medical Center
Hayward Medical Center
Oakland Medical Center
Redwood City Medical Center
Richmond Medical Center
Roseville Medical Center
Sacramento Medical Center
San Francisco Medical Center
San Rafael Medical Center
Santa Clara Medical Center-Homestead
Santa Rosa Medical Center
Santa Teresa Medical Center-San Jose
South Sacramento Medical Center
South San Francisco Medical Center
Vallejo Medical Center
Vallejo Medical Center-Vacaville