Standard Systemic Therapy with or without Definitive Treatment in Treating Participants with Metastatic Prostate Cancer
Your Search Criteria
Category |
Your Selection |
---|---|
Keywords/Phrases: | S1802 |
Description
This phase III trial studies whether the addition of definitive treatment (radiation or surgical removal) of the primary tumor to standard systemic therapy for patients with prostate cancer, may help prevent the cancer from the spreading to other parts of their body. Removing the prostate by either surgery or radiation therapy in addition to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.
Eligibility Criteria
Inclusion Criteria
- STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Patients with pure small cell carcinoma* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible. (*morphology must be consistent with SCC; synaptophysin or chromogranin positive by immunohistochemical staining is insufficient to diagnose SCC).
- STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact prostate.
- STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have at least one of the following scans performed, showing evidence of metastatic disease: * Technetium bone scan OR * Computed tomography (CT) of abdomen & pelvis OR * Magnetic resonance imaging (MRI) of pelvis. Scans must be performed between 42 days prior to start of first hormonal therapy and 14 days following start of first hormonal therapy. Metastatic disease that is detected by positron emission tomography (PET) scan only (sodium fluoride [NaF], prostate-specific membrane antigen [PSMA], anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid [FACBC], carbon [C]11) but not conventional imaging (technetium [Tc]99 bone scan, CT or MRI) or solitary metastases by conventional imaging, must be confirmed histologically or cytologically.
- STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease.
- STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received no more than 28 weeks of standard systemic therapy (SST), as measured from the date of first hormonal therapy (gonadotrophin releasing hormone [LHRH] agonist or LHRH antagonist) or surgical castration. SST is defined as current National Comprehensive Cancer Network (NCCN) guidelines for metastatic prostate cancer.
- STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound ablation [HIFU], cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation).
- STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have received any prior systemic therapy for prostate cancer, outside of line of SST to be used for duration of study.
- STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have progressed while on SST.
- STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients with oligometastatic prostate cancer may receive metastasis directed therapy to up to four sites of disease prior to randomization.
- STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must be >= 18 years of age.
- STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a complete physical examination and medical history within 28 days prior to registration.
- STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a documented PSA: * Prior to initiation of SST * Within 28 days prior to registration * Any additional PSAs measured while receiving SST should be recorded.
- STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone lab documented within 28 days prior to registration. Any additional testosterone labs measured while receiving SST should be recorded as well as pretreatment initiation if available.
- STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
- STEP 1 REGISTRATION: SPECIMEN SUBMISSION CRITERIA: Patients must be offered the opportunity to participate in translational medicine studies and specimen banking for future studies.
- STEP 1 REGISTRATION: QUALITY OF LIFE CRITERIA: Patients who can complete Patient-Reported Outcome instruments in English, Spanish or French, must participate in the quality of life studies.
- STEP 1 REGISTRATION: REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- STEP 1 REGISTRATION: REGULATORY CRITERIA: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
- STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have no evidence of disease progression during the 28 weeks of SST by: * PSA measure * Imaging (bone scan and one of the following: CT of abdomen & pelvis, MRI of abdomen & pelvis, CT of abdomen & MRI of pelvis) within 42 days prior to randomization.
- STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have no evidence of symptomatic deterioration (as defined by physician discretion) within 28 days prior to randomization.
- STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have consultation with a urologist and have surgically resectable disease regardless of definitive treatment intent or randomization.
- STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received between 22 and no more than 28 weeks of SST, as measured from the date of first hormonal therapy (LHRH agonist or LHRH antagonist) or surgical castration. SST is defined by current NCCN guidelines for metastatic prostate cancer.
- STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not be planning to receive docetaxel after randomization.
- STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Any toxicities from SST must have resolved to =< Grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) prior to randomization.
- STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients may have received elective metastasis directed therapy to oligometastatic sites (=< 4 sites). All treatment must be completed prior to randomization.
- STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA performed within 28 days prior to randomization.
- STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone < 50 ng/dL within 28 days prior to randomization.
- STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a Zubrod performance status of 0 – 1 within 28 days prior to randomization.
Locations & Contacts
Arizona
Gilbert
Status: Active
Contact: Site Public Contact
Phone: 602-747-9738
Phoenix
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Tucson
Status: Active
Contact: Site Public Contact
Phone: 800-327-2873
Status: Active
Contact: Site Public Contact
Phone: 520-694-8900
Arkansas
Little Rock
Status: Active
Contact: Site Public Contact
Phone: 501-686-8274
California
Antioch
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Duarte
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
Dublin
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Fremont
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Fresno
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
La Jolla
Status: Active
Contact: Site Public Contact
Phone: 858-822-5354
Email: cancercto@ucsd.edu
Los Angeles
Status: Active
Contact: Site Public Contact
Phone: 323-865-0451
Status: Active
Contact: Site Public Contact
Phone: 323-865-0451
Marysville
Status: Active
Contact: Site Public Contact
Phone: 530-749-4400
Modesto
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Oakland
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Palo Alto
Status: Active
Contact: Site Public Contact
Phone: 650-498-7061
Email: ccto-office@stanford.edu
Rancho Cordova
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Redwood City
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Richmond
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Rohnert Park
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Roseville
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sacramento
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: kpoct@kp.org
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Status: Active
Contact: Site Public Contact
Phone: 916-734-3089
San Francisco
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Jose
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Leandro
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Rafael
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Clara
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Rosa
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South San Francisco
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Stockton
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Truckee
Status: Active
Contact: Site Public Contact
Phone: 530-582-6450
Vacaville
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Vallejo
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Walnut Creek
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Colorado
Aurora
Status: Active
Contact: Site Public Contact
Phone: 720-848-0650
Colorado Springs
Status: Active
Contact: Site Public Contact
Phone: 719-364-6700
Status: Active
Contact: Site Public Contact
Phone: 719-365-2406
Fort Collins
Status: Active
Contact: Site Public Contact
Phone: 970-297-6150
Connecticut
New Haven
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
Delaware
Newark
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
District of Columbia
Washington
Status: Active
Contact: Site Public Contact
Phone: 202-877-8839
Florida
Coral Gables
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Deerfield Beach
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Miami
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
Status: Active
Contact: Site Public Contact
Phone: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com
Plantation
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Georgia
Atlanta
Status: Active
Contact: Site Public Contact
Phone: 404-851-7115
Status: Active
Contact: Site Public Contact
Phone: 404-778-1868
Idaho
Caldwell
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Illinois
Aurora
Status: Active
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com
Chicago
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 312-942-5498
Email: clinical_trials@rush.edu
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Status: Active
Contact: Site Public Contact
Phone: 312-355-3046
Decatur
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Effingham
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Maywood
Status: Active
Contact: Site Public Contact
Phone: 708-226-4357
Peoria
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Swansea
Status: Active
Contact: Site Public Contact
Phone: 618-236-1000
Email: lynns@thecancercenter.com
Urbana
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Indiana
Indianapolis
Status: Active
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu
Iowa
Ames
Status: Active
Contact: Site Public Contact
Phone: 515-239-4734
Email: ksoder@mcfarlandclinic.com
Kansas
Kansas City
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Olathe
Status: Active
Contact: Site Public Contact
Phone: 913-791-3500
Email: Jeni.wakefield@olathehealth.org
Overland Park
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Westwood
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Kentucky
Louisville
Status: Active
Contact: Site Public Contact
Phone: 502-562-3429
Louisiana
Metairie
Status: Active
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu
Status: Active
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu
Maine
Bath
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Brewer
Status: Active
Contact: Site Public Contact
Phone: 800-987-3005
Portland
Status: Active
Contact: Site Public Contact
Phone: 207-885-7565
Sanford
Status: Active
Contact: Site Public Contact
Phone: 207-459-1600
Scarborough
Status: Active
Contact: Site Public Contact
Phone: 207-396-8090
Email: wrighd@mmc.org
Maryland
Baltimore
Status: Active
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu
Michigan
Ann Arbor
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Brownstown
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Clinton Township
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Detroit
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
West Bloomfield
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Minnesota
Coon Rapids
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Fridley
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Minneapolis
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Rochester
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Saint Louis Park
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Shakopee
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Mississippi
Jackson
Status: Active
Contact: Site Public Contact
Phone: 601-815-6700
Missouri
Cape Girardeau
Status: Active
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Status: Active
Contact: Site Public Contact
Phone: 573-651-5550
Creve Coeur
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Kansas City
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-7066
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Saint Peters
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Montana
Great Falls
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Kalispell
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Nebraska
Omaha
Status: Active
Contact: Site Public Contact
Phone: 402-354-5144
Status: Active
Contact: Site Public Contact
Phone: 402-559-6941
Email: unmcrsa@unmc.edu
Nevada
Henderson
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Las Vegas
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
New Hampshire
Concord
Status: Active
Contact: Site Public Contact
Phone: 603-224-2556
Hooksett
Status: Active
Contact: Site Public Contact
Phone: 800-339-6484
New Jersey
Teaneck
Status: Active
Contact: Site Public Contact
Phone: 201-833-6312
New York
Buffalo
Status: Active
Contact: Site Public Contact
Phone: 800-767-9355
Email: askroswell@roswellpark.org
New York
Status: Active
Contact: Site Public Contact
Phone: 212-746-1848
Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-341-8113
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830
Stony Brook
Status: Active
Contact: Site Public Contact
Phone: 800-862-2215
Syracuse
Status: Active
Contact: Site Public Contact
Phone: 315-464-5476
North Carolina
Asheville
Status: Active
Contact: Site Public Contact
Phone: 828-213-2539
Email: Karen.Smith3@HCAHealthcare.com
New Bern
Status: Active
Contact: Site Public Contact
Phone: 252-634-6589
Email: lharrison@carolinaeasthealth.com
Ohio
Canton
Status: Active
Contact: Site Public Contact
Phone: 888-293-4673
Cincinnati
Status: Active
Contact: Site Public Contact
Phone: 513-558-4553
Email: uchealthnews@uc.edu
Columbus
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Kettering
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
West Chester
Status: Active
Contact: Site Public Contact
Email: clinicaltrials@ucphysicians.com
Oklahoma
Oklahoma City
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu
Oregon
Gresham
Status: Active
Contact: Site Public Contact
Phone: 503-413-2150
Portland
Status: Active
Contact: Site Public Contact
Phone: 800-220-4937
Email: cancer@lhs.org
Status: Active
Contact: Site Public Contact
Phone: 503-494-1080
Email: trials@ohsu.edu
Pennsylvania
Danville
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Lewisburg
Status: Active
Contact: Site Public Contact
Phone: 570-374-8555
Email: HemonCCTrials@geisinger.edu
Pittsburgh
Status: Active
Contact: Site Public Contact
Phone: 412-647-8073
Status: Active
Contact: Site Public Contact
Phone: 412-621-2334
Wilkes-Barre
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
South Carolina
Charleston
Status: Active
Contact: Site Public Contact
Phone: 843-792-9321
Email: hcc-clinical-trials@musc.edu
Greenville
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Greer
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Seneca
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Spartanburg
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Tennessee
Nashville
Status: Active
Contact: Site Public Contact
Phone: 800-811-8480
Texas
Houston
Status: Active
Contact: Site Public Contact
Phone: 713-798-1354
Email: burton@bcm.edu
Status: Active
Contact: Site Public Contact
Phone: 713-873-2000
Status: Active
Contact: Site Public Contact
Phone: 713-566-5000
Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
Email: askmdanderson@mdanderson.org
Status: Active
Contact: Site Public Contact
Phone: 713-790-2700
Utah
American Fork
Status: Active
Contact: Site Public Contact
Phone: 801-855-4100
Email: officeofresearch@imail.org
Cedar City
Status: Active
Contact: Site Public Contact
Phone: 435-868-5680
Email: officeofresearch@imail.org
Logan
Status: Active
Contact: Site Public Contact
Phone: 435-716-6400
Email: officeofresearch@imail.org
Murray
Status: Active
Contact: Site Public Contact
Phone: 801-507-3950
Email: officeofresearch@imail.org
Ogden
Status: Active
Contact: Site Public Contact
Phone: 801-387-7426
Email: officeofresearch@imail.org
Provo
Status: Active
Contact: Site Public Contact
Phone: 801-357-7965
Email: officeofresearch@imail.org
Riverton
Status: Active
Contact: Site Public Contact
Phone: 801-507-3950
Email: officeofresearch@imail.org
Saint George
Status: Active
Contact: Site Public Contact
Phone: 435-688-4167
Email: officeofresearch@imail.org
Salt Lake City
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu
Status: Active
Contact: Site Public Contact
Phone: 801-408-1347
Email: officeofresearch@imail.org
Status: Active
Contact: Site Public Contact
Phone: 801-933-6070
Email: officeofresearch@imail.org
Virginia
Richmond
Status: Active
Contact: Site Public Contact
Phone: 804-628-1939
Email: mwellons@vcu.edu
Status: Active
Contact: Site Public Contact
Phone: 804-628-1914
Email: klcampbell@vcu.edu
South Hill
Status: Active
Contact: Site Public Contact
Phone: 434-774-2442
Email: sherman.baker@vcuhealth.org
Washington
Seattle
Status: Active
Contact: Site Public Contact
Phone: 800-804-8824
Status: Active
Contact: Site Public Contact
Phone: 800-804-8824
Vancouver
Status: Active
Contact: Site Public Contact
Phone: 503-413-2150
Wisconsin
Antigo
Status: Active
Contact: Site Public Contact
Phone: 715-623-9869
Email: Juli.Alford@aspirus.org
Eau Claire
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
La Crosse
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Marshfield
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Menomonee Falls
Status: Active
Contact: Site Public Contact
Phone: 262-257-5100
Milwaukee
Status: Active
Contact: Site Public Contact
Phone: 414-805-3666
Minocqua
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Rice Lake
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Stevens Point
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Wausau
Status: Active
Contact: Site Public Contact
Phone: 877-405-6866
West Bend
Status: Active
Contact: Site Public Contact
Phone: 866-680-0505
Weston
Status: Active
Contact: Site Public Contact
Phone: 888-799-3989
Email: oncology.clinical.trials@marshfieldresearch.org
Trial Objectives and Outline
PRIMARY OBJECTIVE:
I. To compare overall survival in metastatic prostate cancer patients who are randomized to standard systemic therapy (SST) plus definitive treatment of the primary tumor versus standard systemic therapy alone.
SECONDARY OBJECTIVES:
I. To compare overall survival in metastatic prostate cancer patients who received SST plus surgical excision of the primary tumor versus SST alone in the subset who specify the surgical intent stratification factor.
II. To compare the rate of symptomatic local progression between the treatment arms.
III. To compare progression-free survival (PFS) between the two treatment arms.
IV. To compare rates of progression-free survival between arms for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites.
QUALITY OF LIFE OBJECTIVE:
I. To compare between arms patient-reported urinary function and urinary bother over time (after initiation of SST at 6 months, 1, 2, and 3 years) using the Expanded Prostate Cancer Index Composite (EPIC) and patient-reported pain and physical functioning using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) between patients receiving standard systemic therapy and those receiving systemic therapy and definitive management of the primary prostate cancer.
OTHER OBJECTIVE:
I. To bank tissue and whole blood specimens for future use.
OUTLINE:
INDUCTION: Participants receive 1 of 6 acceptable forms of SST for 22-28 weeks.
I. Participants undergo a bilateral orchiectomy.
II. Participants receive goserelin acetate subcutaneously (SC) every 28 days or 12 weeks, histrelin acetate SC every 12 months, leuprolide acetate SC or intramuscularly (IM) every 1, 3, 4, or 6 months, and triptorelin every 1, 3, or 6 months.
III. Participants receive goserelin acetate SC every 28 days or 12 weeks, histrelin acetate SC every 12 months, leuprolide acetate SC or IM every 1, 3, 4, or 6 months, and triptorelin every 1, 3, or 6 months. Participants also receive nilutamide orally (PO) daily, flutamide PO every 8 hours, and bicalutamide PO daily.
IV. Participants receive degarelix via injection for 2 doses and then every 28 days.
V. Participants receive nilutamide PO daily, flutamide PO every 8 hours, and bicalutamide PO daily. Participants also receive docetaxel over 1 hour every 3 weeks with or without prednisone PO every 12 hours.
VI. Participants receive nilutamide PO daily, flutamide PO every 8 hours, and bicalutamide PO daily. Participants also receive abiraterone PO daily or prednisone PO every 12 hours.
After completion of 22-28 weeks of SST, participants are then randomized to 1 of 2 arms.
ARM I: Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone.
ARM II: Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Participants undergo prostatectomy within 8 weeks after randomization or radiation therapy within 4 weeks of randomization.
After completion of study treatment, participants are followed up for 8 years.
Trial Phase & Type
Treatment
Lead Organization
Lead Organization
SWOG
Principal Investigator
Brian Francis Chapin