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JOURNAL ONKOLOGIE – STUDIE

Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

Rekrutierend

NCT-Nummer:
NCT03678025

Studienbeginn:
September 2018

Letztes Update:
14.08.2023

Wirkstoff:
Abiraterone, Bicalutamide, Degarelix, Docetaxel, Flutamide, Goserelin acetate, Histrelin Acetate, Leuprolide Acetate, Nilutamide, Prednisone, Triptorelin

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
SWOG Cancer Research Network

Collaborator:
National Cancer Institute (NCI)

Studienleiter

Brian Chapin
Principal Investigator
SWOG Cancer Research Network

Kontakt

Studienlocations
(3 von 338)

Mayo Clinic Hospital in Arizona
85054 Phoenix
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Mayo Clinic in Arizona
85259 Scottsdale
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University Oncology Associates
93611 Clovis
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Pacific Central Coast Health Center-San Luis Obispo
93401 San Luis Obispo
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Site Public Contact
Phone: 805-219-4673
E-Mail: ResearchInstituteInquiries@CommonSpirit.org» Ansprechpartner anzeigen
Veterans Affairs Connecticut Healthcare System-West Haven Campus
06516 West Haven
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Site Public Contact
Phone: 203-937-3421
Phone (ext.): 2832» Ansprechpartner anzeigen
Christiana Care Health System-Christiana Hospital
19718 Newark
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Phone: 302-623-4450
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MedStar Georgetown University Hospital
20007 Washington
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MedStar Washington Hospital Center
20010 Washington
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Orlando Health Cancer Institute
32806 Orlando
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Saint Alphonsus Cancer Care Center-Caldwell
83605 Caldwell
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Phone: 734-712-3671
E-Mail: stephanie.couch@stjoeshealth.org» Ansprechpartner anzeigen
Northwestern University
60611 Chicago
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University of Chicago Comprehensive Cancer Center
60637 Chicago
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Southwest Illinois Health Services LLP
62226 Swansea
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Indiana University/Melvin and Bren Simon Cancer Center
46202 Indianapolis
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University of Kansas Cancer Center-Overland Park
66210 Overland Park
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Phone: 913-588-3671
E-Mail: KUCC_Navigation@kumc.edu» Ansprechpartner anzeigen
University of Kansas Hospital-Westwood Cancer Center
66205 Westwood
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Phone: 913-588-3671
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Saint Joseph Radiation Oncology Resource Center
40504 Lexington
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Phone: 859-629-7169
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LSU Healthcare Network / Metairie Multi-Specialty Clinic
70006 Metairie
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Phone: 504-210-3539
E-Mail: emede1@lsuhsc.edu» Ansprechpartner anzeigen
Johns Hopkins University/Sidney Kimmel Cancer Center
21287 Baltimore
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Lahey Hospital and Medical Center
01805 Burlington
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Henry Ford Macomb Hospital-Clinton Township
48038 Clinton Township
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Site Public Contact
Phone: 313-916-3721
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GenesisCare USA - Farmington Hills
48334 Farmington Hills
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Phone: 941-833-5700
E-Mail: Rudi.Ross@usa.genesiscare.com» Ansprechpartner anzeigen
Mayo Clinic in Rochester
55905 Rochester
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Park Nicollet Clinic - Saint Louis Park
55416 Saint Louis Park
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Phone: 952-993-1517
E-Mail: mmcorc@healthpartners.com» Ansprechpartner anzeigen
University of Mississippi Medical Center
39216 Jackson
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Siteman Cancer Center at Saint Peters Hospital
63376 Saint Peters
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Phone: 800-600-3606
E-Mail: info@siteman.wustl.edu» Ansprechpartner anzeigen
Comprehensive Cancer Centers of Nevada - Central Valley
89169 Las Vegas
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Site Public Contact
Phone: 702-384-0013
E-Mail: research@sncrf.org» Ansprechpartner anzeigen
Wentworth-Douglass Hospital
03820 Dover
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Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
03756 Lebanon
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Phone: 800-639-6918
E-Mail: cancer.research.nurse@dartmouth.edu» Ansprechpartner anzeigen
Elliot Hospital
03103 Manchester
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Holy Name Hospital
07666 Teaneck
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James J Peters VA Medical Center
10468 Bronx
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Northwell Health/Center for Advanced Medicine
11042 Lake Success
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Mission Hospital
28801 Asheville
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Margaret R Pardee Memorial Hospital
28791 Hendersonville
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Ansprechpartner:
Site Public Contact
Phone: 828-696-4716
E-Mail: pardeecancerresearch@unchealth.unc.edu» Ansprechpartner anzeigen
University of Cincinnati Cancer Center-UC Medical Center
45219 Cincinnati
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Site Public Contact
Phone: 513-584-7698
E-Mail: cancer@uchealth.com» Ansprechpartner anzeigen
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
43606 Toledo
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Phone: 419-824-1842
E-Mail: PCIOncResearch@promedica.org» Ansprechpartner anzeigen
University of Cincinnati Cancer Center-West Chester
45069 West Chester
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Phone: 513-584-7698
E-Mail: cancer@uchealth.com» Ansprechpartner anzeigen
University of Oklahoma Health Sciences Center
73104 Oklahoma City
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Phone: 405-271-8777
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Legacy Mount Hood Medical Center
97030 Gresham
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Legacy Good Samaritan Hospital and Medical Center
97210 Portland
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Oregon Health and Science University
97239 Portland
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Temple University Hospital
19140 Philadelphia
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Geisinger Wyoming Valley/Henry Cancer Center
18711 Wilkes-Barre
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Phone: 570-271-5251
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UT Southwestern Simmons Cancer Center - RedBird
75237 Dallas
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Phone: 214-648-7097
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UT Southwestern/Simmons Cancer Center-Dallas
75390 Dallas
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Phone: 214-648-7097
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UT Southwestern/Simmons Cancer Center-Fort Worth
76104 Fort Worth
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Phone: 214-648-7097
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Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
77030 Houston
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Phone: 713-798-1354
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Houston Methodist Hospital
77030 Houston
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UT Southwestern Clinical Center at Richardson/Plano
75080 Richardson
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Phone: 972-669-7044
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University of Texas Health Science Center at San Antonio
78229 San Antonio
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Scott and White Memorial Hospital
76508 Temple
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American Fork Hospital / Huntsman Intermountain Cancer Center
84003 American Fork
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Sandra L Maxwell Cancer Center
84720 Cedar City
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Intermountain Medical Center
84107 Murray
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Utah Valley Regional Medical Center
84604 Provo
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Saint George Regional Medical Center
84770 Saint George
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University of Utah Sugarhouse Health Center
84106 Salt Lake City
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Ansprechpartner:
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Phone: 888-424-2100
E-Mail: cancerinfo@hci.utah.edu» Ansprechpartner anzeigen
Utah Cancer Specialists-Salt Lake City
84106 Salt Lake City
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Huntsman Cancer Institute/University of Utah
84112 Salt Lake City
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Phone: 888-424-2100
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Bon Secours Cancer Institute at Reynolds Crossing
23230 Richmond
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Site Public Contact
Phone: 804-893-8978
E-Mail: Anne_caramella@bshsi.org» Ansprechpartner anzeigen
Legacy Salmon Creek Hospital
98686 Vancouver
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Marshfield Medical Center-EC Cancer Center
54701 Eau Claire
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Ansprechpartner:
Site Public Contact
Phone: 800-782-8581
E-Mail: oncology.clinical.trials@marshfieldresearch.org» Ansprechpartner anzeigen
Mayo Clinic Health System-Franciscan Healthcare
54601 La Crosse
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Marshfield Medical Center-Marshfield
54449 Marshfield
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Ansprechpartner:
Site Public Contact
Phone: 800-782-8581
E-Mail: oncology.clinical.trials@marshfieldresearch.org» Ansprechpartner anzeigen
Marshfield Clinic-Minocqua Center
54548 Minocqua
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Site Public Contact
Phone: 800-782-8581
E-Mail: oncology.clinical.trials@marshfieldresearch.org» Ansprechpartner anzeigen
Marshfield Medical Center-Rice Lake
54868 Rice Lake
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Ansprechpartner:
Site Public Contact
Phone: 800-782-8581
E-Mail: oncology.clinical.trials@marshfieldresearch.org» Ansprechpartner anzeigen
Marshfield Medical Center-River Region at Stevens Point
54482 Stevens Point
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Ansprechpartner:
Site Public Contact
Phone: 800-782-8581
E-Mail: oncology.clinical.trials@marshfieldresearch.org» Ansprechpartner anzeigen
Diagnostic and Treatment Center
54476 Weston
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Ansprechpartner:
Site Public Contact
Phone: 888-799-3989
E-Mail: oncology.clinical.trials@marshfieldresearch.org» Ansprechpartner anzeigen
Marshfield Medical Center - Weston
54476 Weston
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Ansprechpartner:
Site Public Contact
Phone: 800-782-8581
E-Mail: oncology.clinical.trials@marshfieldresearch.org» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

PRIMARY OBJECTIVES:

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 OBJECTIVES:

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 OBJECTIVES:

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.

Ein-/Ausschlusskriterien

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.

No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy,

high-intensity focused ultrasound [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: DISEASE-RELATED CRITERIA: Patients must have evidence of

metastatic disease on technetium bone scan and computed tomography (CT) or magnetic

resonance imaging (MRI) within 42 days prior to starting standard systemic 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). SST is defined as current

National Comprehensive Cancer Network (NCCN) guidelines for metastatic prostate

cancer.

- 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 have a complete

physical examination and medical history within 28 days prior to registration.

- STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA documented

prior to initiation of SST and 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 randomization. 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 2 RANDOMIZATION: DISEASE-RELATED 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, bone scan and CT or MRI

or 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 28 weeks of SST as measured from the date of first hormonal therapy 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.

Studien-Rationale

Primary outcome:

1. Overall survival (OS) (Time Frame - From date of randomization to date of death due to any cause, assessed up to 8 years)



Secondary outcome:

1. Media OS (Time Frame - From date of randomization to date of death due to any cause, assessed up to 8 years):
Will compare OS in metastatic prostate cancer patients who received standard systemic therapy (SST) plus surgical excision of the primary tumor versus SST alone in the subset who specify the surgical intent stratification factor.

2. Rate of symptomatic local progression (Time Frame - Up to 8 years):
Defined as any of the following events post-randomization: Common Terminology Criteria for Adverse Events version 5 grade >= 2 hematuria, urinary retention, urinary tract obstruction, urinary tract pain, pelvic pain, renal and urinary disorders-other. Will be compared between the treatment arms. A proportional hazards model will be fit to each of these endpoints where the time interval starts at date of randomization to (i) time of first symptomatic local progression or ii) progression or death due to any cause, where those without the event are censored at their last contact date. Stratification factors will be adjusted for as covariates.

3. Progression-free survival (PFS) (Time Frame - From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 8 years):
Will be compared between for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites. A proportional hazards model will be fit to each of these endpoints where the time interval starts at date of randomization to (i) time of first symptomatic local progression or ii) progression or death due to any cause, where those without the event are censored at their last contact date. Stratification factors will be adjusted for as covariates.

Studien-Arme

  • Active Comparator: Arm I (SST)
    Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone.
  • Experimental: Arm II (SST, prostatectomy or radiation therapy)
    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.
  • Active Comparator: Step 1 (pre-randomization)
    Standard treatment data collection prior to randomization

Geprüfte Regime

  • Abiraterone (CB 7598):
    Given PO
  • Bicalutamide (Casodex / Cosudex / ICI 176,334 / ICI 176334 / ):
    Given PO
  • Degarelix (FE200486 / Firmagon / ):
    Given via injection
  • Docetaxel (Docecad / RP56976 / Taxotere / Taxotere Injection Concentrate / ):
    intravenous
  • Flutamide (4'-Nitro-3'-trifluoromethylisobutyranilide / Apimid / Cebatrol / Chimax / Cytomid / Drogenil / Euflex / Eulexine / Flucinom / Flucinome / Flugerel / Fluken / Flulem / FLUT / Fluta-Gry / Flutabene / Flutacan / Flutamex / Flutamin / Flutan / Flutaplex / Fugerel / Grisetin / Niftolide / Oncosal / Profamid / Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)- / Prostacur / Prostadirex / Prostica / Prostogenat / SCH 13521 / Tafenil / Tecnoflut / Testotard / ):
    Given PO
  • Goserelin Acetate (ZDX / Zoladex / ):
    Given SC
  • Histrelin Acetate (Supprelin / Vantas / ):
    Receive SC
  • Leuprolide Acetate (A-43818 / Abbott 43818 / Abbott-43818 / Carcinil / Depo-Eligard / Eligard / Enanton / Enantone / Enantone-Gyn / Ginecrin / LEUP / Leuplin / Leuprorelin Acetate / Lucrin / Lucrin Depot / Lupron / Lupron Depot / Lupron Depot-3 Month / Lupron Depot-4 Month / Lupron Depot-Ped / Procren / Procrin / Prostap / TAP-144 / Trenantone / Uno-Enantone / Viadur / ):
    Receive SC or IM
  • Nilutamide (Anandron / Nilandron / RU-23908 / ):
    Given PO
  • Orchiectomy (Castration / Male Castration / Male Gonadectomy / orchidectomy / ):
    Undergo bilateral orchiectomy
  • Prednisone (.delta.1-Cortisone / 1, 2-Dehydrocortisone / Adasone / Cortancyl / Dacortin / DeCortin / Decortisyl / Decorton / Delta 1-Cortisone / Delta-Dome / Deltacortene / Deltacortisone / Deltadehydrocortisone / Deltasone / Deltison / Deltra / Econosone / Lisacort / Meprosona-F / Metacortandracin / Meticorten / Ofisolona / Orasone / Panafcort / Panasol-S / Paracort / PRED / Predicor / Predicorten / Prednicen-M / Prednicort / Prednidib / Prednilonga / Predniment / Prednisonum / Prednitone / Promifen / Servisone / SK-Prednisone / ):
    Given PO
  • Quality-of-Life Assessment (Quality of Life Assessment):
    Ancillary studies
  • Radiation Therapy (Cancer Radiotherapy / Irradiate / Irradiated / irradiation / Radiation / Radiotherapeutics / RADIOTHERAPY / RT / Therapy, Radiation / ):
    Standard radiation
  • Radical Prostatectomy (Prostatovesiculectomy):
    Standard surgery
  • Triptorelin (6-D-Tryptophan-LH-RH / 6-D-Tryptophanluteinizing Hormone-releasing Factor / AY-25650 / CL-118,532 / Decapeptyl / Detryptoreline / ):
    injection

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer"

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