A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy With or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? Quality-of-Life Assessment+Stereotactic Body Radiation Therapy
Status: Recruiting
Location: See all (229) locations...
Intervention Type: Procedure, Drug, Radiation, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial compares the usual treatment of radiation therapy alone to using the study drug, relugolix, plus the usual radiation therapy in patients with castration-sensitive prostate cancer that has spread to limited other parts of the body (oligometastatic). Relugolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. It may stop the growth of cancer cells that need testosterone to grow. Radiation therapy uses high-energy x rays or protons to kill tumor cells. The addition of relugolix to the radiation may reduce the chance of oligometastatic prostate cancer spreading further.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Pathologically (histologically or cytologically) proven diagnosis of prostate adenocarcinoma at any anatomical location (for example, prostate, metastatic site), including intraductal or ductal carcinoma, at any time before registration

• Age \>= 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 180 days prior to registration

• Prior curative-intent treatment to the prostate, by either:

‣ External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites

⁃ Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.

• Note: Patients who have received curative intent with radiation prior to prostatectomy are eligible and should be categorized as RT to Intact Prostate since that was the first curative intent

• Must meet study entry criteria based on the following diagnostic workup within 120 days prior to registration:

‣ History and physical examination;

⁃ Fluciclovine or PSMA PET scan;

⁃ PET must be combined with either CT or MRI, but a diagnostic CT or MRI reading/interpretation is not required

• 1 - 5 oligometastatic lesions in bone and/or nodal/soft tissue (non-abutting nodes are counted separately) sites on fluciclovine or PSMA PET within 180 days prior to registration and includes at least ONE of the following:

‣ Bone - each metastasis is counted (for example, 2 distinct lesions in the right ilium count as 2 oligometastatic lesions)

⁃ Extrapelvic Nodal/ soft tissue - requires at least one extrapelvic inguinal or a nodal/soft tissue lesion superior to the iliac bifurcation (that is, American Joint Committee on Cancer \[AJCC\] M1a version 8)

⁃ Note: Although a patient must have bone and/or extrapelvic disease to be eligible, when counting the number of oligometastatic lesions, each lymph node lesion, whether pelvic or extrapelvic, is counted (for example, 2 distinct lymph nodes in the right external iliac basin count as 2 oligometastatic lesions; one extrapelvic and one pelvic node count as 2 oligometastic lesions, etc)

• Serum total prostate-specific antigen (PSA) =\< 10.0 ng/mL that also meets ONE of the following PSA recurrence definitions:

‣ If patient has received-radiation therapy to intact prostate, either

• PSA \> post-RT nadir PSA + 2 ng/mL obtained within 180 days prior to registration, or

∙ PSA \> 0.2 ng/mL with at least two rises from post-treatment nadir with the most recent PSA within 180 days prior to registration

⁃ If patient has received a radical prostatectomy with or without post-op RT, either

• Current PSA \> 0.2 ng/mL, with a second confirmatory PSA \> 0.2 ng/mL, with most recent PSA obtained within 180 days prior to registration, or

∙ Two consecutive PSA rises from post-operative nadir, with most recent PSA obtained within 180 days prior to registration

• Must have \>= 3 PSA values within the last two years since end of primary treatment or within the last 2 years prior to registration, whichever is less

‣ Note: PSA doubling time must be calculated by entering all PSA values since end of primary treatment or within the last 2 years prior to registration (whichever is less) into the PSA Doubling Time Calculator found at MDCalc.com

• Serum total testosterone \>= 100 ng/dL within 180 days prior to registration

‣ Note: Prior androgen deprivation therapy (other than bilateral orchiectomy) is allowed if discontinued prior to registration and serum total testosterone is \>= 100 ng/dL

• Total bilirubin: =\< 1.5 x institutional upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, subject is eligible if direct bilirubin is =\< 1.5 x ULN) (within 180 days prior to registration)

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]): =\< 2.5 x institutional ULN (within 180 days prior to registration)

• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

‣ Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)

• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

‣ Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy

• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

• The patient must agree to use a highly effective contraception (even men with vasectomies) if he is having sex with a woman of childbearing potential or with a woman who is pregnant while on study drug and for 2 weeks following the last dose of study drug

• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

Locations
United States
Arizona
Cancer Center at Saint Joseph's
RECRUITING
Phoenix
California
Alta Bates Summit Medical Center-Herrick Campus
RECRUITING
Berkeley
Tower Cancer Research Foundation
RECRUITING
Beverly Hills
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITING
Irvine
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Los Angeles General Medical Center
ACTIVE_NOT_RECRUITING
Los Angeles
USC / Norris Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Los Angeles
Memorial Medical Center
RECRUITING
Modesto
UC Irvine Health/Chao Family Comprehensive Cancer Center
RECRUITING
Orange
Sutter Pacific Medical Foundation
RECRUITING
Santa Rosa
Sutter Solano Medical Center/Cancer Center
RECRUITING
Vallejo
Colorado
UCHealth University of Colorado Hospital
RECRUITING
Aurora
Rocky Mountain Cancer Centers-Boulder
RECRUITING
Boulder
Memorial Hospital North
RECRUITING
Colorado Springs
UCHealth Memorial Hospital Central
RECRUITING
Colorado Springs
Shaw Cancer Center
RECRUITING
Edwards
Cancer Care and Hematology-Fort Collins
RECRUITING
Fort Collins
Poudre Valley Hospital
RECRUITING
Fort Collins
Banner North Colorado Medical Center
SUSPENDED
Greeley
UCHealth Greeley Hospital
RECRUITING
Greeley
UCHealth Highlands Ranch Hospital
RECRUITING
Highlands Ranch
AdventHealth Littleton
RECRUITING
Littleton
Banner McKee Medical Center
SUSPENDED
Loveland
Medical Center of the Rockies
RECRUITING
Loveland
Washington, D.c.
George Washington University Medical Center
RECRUITING
Washington D.c.
Delaware
Beebe South Coastal Health Campus
RECRUITING
Millville
Helen F Graham Cancer Center
RECRUITING
Newark
Medical Oncology Hematology Consultants PA
RECRUITING
Newark
Beebe Health Campus
RECRUITING
Rehoboth Beach
Florida
AdventHealth Altamonte
RECRUITING
Altamonte Springs
AdventHealth Celebration
RECRUITING
Celebration
Jupiter Medical Center
ACTIVE_NOT_RECRUITING
Jupiter
GenesisCare USA - Lakewood Ranch
SUSPENDED
Lakewood Rch
AdventHealth Orlando
RECRUITING
Orlando
GenesisCare USA - Plantation
SUSPENDED
Plantation
Moffitt Cancer Center
RECRUITING
Tampa
Moffitt Cancer Center - McKinley Campus
RECRUITING
Tampa
Moffitt Cancer Center-International Plaza
RECRUITING
Tampa
Cleveland Clinic-Weston
RECRUITING
Weston
Georgia
Emory Saint Joseph's Hospital
RECRUITING
Atlanta
Emory University Hospital Midtown
RECRUITING
Atlanta
Emory University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Grady Health System
RECRUITING
Atlanta
Piedmont Hospital
SUSPENDED
Atlanta
WellStar Cobb Hospital
RECRUITING
Austell
Emory Decatur Hospital
RECRUITING
Decatur
Piedmont Fayette Hospital
SUSPENDED
Fayetteville
Emory Johns Creek Hospital
RECRUITING
Johns Creek
Iowa
Mary Greeley Medical Center
RECRUITING
Ames
McFarland Clinic - Ames
RECRUITING
Ames
Iowa Methodist Medical Center
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic
RECRUITING
Des Moines
Illinois
Alton Memorial Hospital
RECRUITING
Alton
Advocate Good Shepherd Hospital
RECRUITING
Barrington
Advocate Illinois Masonic Medical Center
RECRUITING
Chicago
AMG Crystal Lake - Oncology
RECRUITING
Crystal Lake
Carle at The Riverfront
RECRUITING
Danville
Decatur Memorial Hospital
RECRUITING
Decatur
Advocate Good Samaritan Hospital
RECRUITING
Downers Grove
Crossroads Cancer Center
RECRUITING
Effingham
Advocate Sherman Hospital
RECRUITING
Elgin
Advocate South Suburban Hospital
RECRUITING
Hazel Crest
AMG Libertyville - Oncology
RECRUITING
Libertyville
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
HSHS Saint Elizabeth's Hospital
RECRUITING
O'fallon
Advocate Christ Medical Center
RECRUITING
Oak Lawn
Advocate Lutheran General Hospital
RECRUITING
Park Ridge
Methodist Medical Center of Illinois
RECRUITING
Peoria
OSF Saint Francis Medical Center
RECRUITING
Peoria
Memorial Hospital East
RECRUITING
Shiloh
Springfield Memorial Hospital
RECRUITING
Springfield
Carle Cancer Center
RECRUITING
Urbana
Indiana
Parkview Regional Medical Center
ACTIVE_NOT_RECRUITING
Fort Wayne
Goshen Center for Cancer Care
RECRUITING
Goshen
Kentucky
The James Graham Brown Cancer Center at University of Louisville
RECRUITING
Louisville
UofL Health Medical Center Northeast
RECRUITING
Louisville
Louisiana
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
East Jefferson General Hospital
RECRUITING
Metairie
LSU Healthcare Network / Metairie Multi-Specialty Clinic
RECRUITING
Metairie
Mary Bird Perkins Cancer Center - Metairie
RECRUITING
Metairie
University Medical Center New Orleans
RECRUITING
New Orleans
Michigan
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
RECRUITING
Ann Arbor
Trinity Health IHA Medical Group Hematology Oncology - Brighton
RECRUITING
Brighton
Trinity Health Medical Center - Brighton
RECRUITING
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton
RECRUITING
Canton
Trinity Health Medical Center - Canton
RECRUITING
Canton
Chelsea Hospital
RECRUITING
Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
RECRUITING
Chelsea
Michigan Healthcare Professionals Clarkston
RECRUITING
Clarkston
Michigan Healthcare Professionals Farmington
RECRUITING
Farmington Hills
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
RECRUITING
Grand Rapids
Trinity Health Grand Rapids Hospital
RECRUITING
Grand Rapids
Bronson Methodist Hospital
RECRUITING
Kalamazoo
University of Michigan Health - Sparrow Lansing
RECRUITING
Lansing
Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITING
Livonia
Michigan Healthcare Professionals Macomb
RECRUITING
Macomb
Michigan Healthcare Professionals Madison Heights
RECRUITING
Madison Heights
Trinity Health Saint Joseph Mercy Oakland Hospital
RECRUITING
Pontiac
Corewell Health William Beaumont University Hospital
RECRUITING
Royal Oak
Munson Medical Center
RECRUITING
Traverse City
Corewell Health Beaumont Troy Hospital
RECRUITING
Troy
Michigan Healthcare Professionals Troy
RECRUITING
Troy
University of Michigan Health - West
RECRUITING
Wyoming
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RECRUITING
Ypsilanti
Minnesota
Regions Hospital
RECRUITING
Saint Paul
Missouri
Saint Francis Medical Center
RECRUITING
Cape Girardeau
Siteman Cancer Center at Saint Peters Hospital
RECRUITING
City Of Saint Peters
Siteman Cancer Center at West County Hospital
RECRUITING
Creve Coeur
Phelps Health Delbert Day Cancer Institute
RECRUITING
Rolla
Siteman Cancer Center at Christian Hospital
RECRUITING
St Louis
Siteman Cancer Center-South County
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
Montana
Benefis Sletten Cancer Institute
RECRUITING
Great Falls
North Carolina
East Carolina University
RECRUITING
Greenville
North Dakota
Sanford Broadway Medical Center
RECRUITING
Fargo
Sanford Roger Maris Cancer Center
RECRUITING
Fargo
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING
Lebanon
New Jersey
The Valley Hospital - Luckow Pavilion
RECRUITING
Paramus
New Mexico
University of New Mexico Cancer Center
RECRUITING
Albuquerque
New York
Roswell Park Cancer Institute
RECRUITING
Buffalo
Highland Hospital
RECRUITING
Rochester
University of Rochester
RECRUITING
Rochester
Wilmot Cancer Institute at Webster
RECRUITING
Webster
Ohio
UH Seidman Cancer Center at UH Avon Health Center
ACTIVE_NOT_RECRUITING
Avon
UHHS-Chagrin Highlands Medical Center
ACTIVE_NOT_RECRUITING
Beachwood
Miami Valley Hospital South
RECRUITING
Centerville
Case Western Reserve University
ACTIVE_NOT_RECRUITING
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
RECRUITING
Cleveland
Cleveland Clinic Foundation
RECRUITING
Cleveland
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Miami Valley Hospital
RECRUITING
Dayton
Miami Valley Hospital North
RECRUITING
Dayton
Premier Blood and Cancer Center
RECRUITING
Dayton
Atrium Medical Center-Middletown Regional Hospital
RECRUITING
Franklin
Hillcrest Hospital Cancer Center
RECRUITING
Mayfield Heights
UH Seidman Cancer Center at Lake Health Mentor Campus
ACTIVE_NOT_RECRUITING
Mentor
University Hospitals Parma Medical Center
ACTIVE_NOT_RECRUITING
Parma
University Hospitals Portage Medical Center
ACTIVE_NOT_RECRUITING
Ravenna
Cleveland Clinic Cancer Center Strongsville
RECRUITING
Strongsville
ProMedica Flower Hospital
RECRUITING
Sylvania
Upper Valley Medical Center
RECRUITING
Troy
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
UPMC Altoona
RECRUITING
Altoona
UPMC-Heritage Valley Health System Beaver
RECRUITING
Beaver
Bryn Mawr Hospital
RECRUITING
Bryn Mawr
Carlisle Regional Cancer Center
RECRUITING
Carlisle
Christiana Care Health System-Concord Health Center
RECRUITING
Chadds Ford
Chambersburg Hospital
RECRUITING
Chambersburg
Geisinger Medical Center
RECRUITING
Danville
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
ACTIVE_NOT_RECRUITING
East Norriton
Ephrata Cancer Center
RECRUITING
Ephrata
UPMC Hillman Cancer Center Erie
RECRUITING
Erie
UPMC Cancer Center at UPMC Horizon
RECRUITING
Farrell
Fox Chase Cancer Center Buckingham
ACTIVE_NOT_RECRUITING
Furlong
Adams Cancer Center
RECRUITING
Gettysburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
RECRUITING
Harrisburg
Penn State Milton S Hershey Medical Center
RECRUITING
Hershey
IRMC Cancer Center
RECRUITING
Indiana
Sechler Family Cancer Center
RECRUITING
Lebanon
Geisinger Medical Oncology-Lewisburg
RECRUITING
Lewisburg
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
RECRUITING
Mechanicsburg
Riddle Memorial Hospital
RECRUITING
Media
UPMC Hillman Cancer Center in Coraopolis
RECRUITING
Moon Township
Paoli Memorial Hospital
RECRUITING
Paoli
Fox Chase Cancer Center
ACTIVE_NOT_RECRUITING
Philadelphia
University of Pittsburgh Cancer Institute (UPCI)
RECRUITING
Pittsburgh
UPMC-Magee Womens Hospital
RECRUITING
Pittsburgh
UPMC-Passavant Hospital
RECRUITING
Pittsburgh
UPMC-Saint Margaret
RECRUITING
Pittsburgh
UPMC-Shadyside Hospital
RECRUITING
Pittsburgh
Geisinger Cancer Services-Pottsville
RECRUITING
Pottsville
UPMC Cancer Center at UPMC Northwest
RECRUITING
Seneca
UPMC Washington Hospital Radiation Oncology
RECRUITING
Washington
Geisinger Wyoming Valley/Henry Cancer Center
RECRUITING
Wilkes-barre
Divine Providence Hospital
RECRUITING
Williamsport
Lankenau Medical Center
RECRUITING
Wynnewood
UPMC Memorial
RECRUITING
York
WellSpan Health-York Cancer Center
RECRUITING
York
South Carolina
Ralph H Johnson VA Medical Center
RECRUITING
Charleston
Carolina Regional Cancer Center
SUSPENDED
Myrtle Beach
South Dakota
Sanford Cancer Center Oncology Clinic
RECRUITING
Sioux Falls
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Texas
Covenant Medical Center-Lakeside
RECRUITING
Lubbock
Virginia
Bon Secours Saint Francis Medical Center
RECRUITING
Midlothian
Bon Secours Cancer Institute at Reynolds Crossing
RECRUITING
Richmond
VCU Massey Cancer Center at Stony Point
RECRUITING
Richmond
VCU Massey Comprehensive Cancer Center
RECRUITING
Richmond
VCU Community Memorial Health Center
RECRUITING
South Hill
Vermont
Central Vermont Medical Center/National Life Cancer Treatment
RECRUITING
Berlin Corners
University of Vermont Medical Center
RECRUITING
Burlington
Dartmouth Cancer Center - North
RECRUITING
Saint Johnsbury
Washington
FHCC at EvergreenHealth
RECRUITING
Kirkland
FHCC at Northwest Hospital
RECRUITING
Seattle
Fred Hutchinson Cancer Center
RECRUITING
Seattle
University of Washington Medical Center - Montlake
RECRUITING
Seattle
Wisconsin
Langlade Hospital and Cancer Center
RECRUITING
Antigo
Marshfield Medical Center-EC Cancer Center
RECRUITING
Eau Claire
Aurora Cancer Care-Grafton
RECRUITING
Grafton
Aurora BayCare Medical Center
RECRUITING
Green Bay
Aurora Bay Area Medical Group-Marinette
RECRUITING
Marinette
Marshfield Medical Center-Marshfield
RECRUITING
Marshfield
Froedtert Menomonee Falls Hospital
RECRUITING
Menomonee Falls
Aurora Saint Luke's Medical Center
RECRUITING
Milwaukee
Aurora Sinai Medical Center
RECRUITING
Milwaukee
Medical College of Wisconsin
RECRUITING
Milwaukee
Marshfield Medical Center - Minocqua
RECRUITING
Minocqua
ProHealth D N Greenwald Center
RECRUITING
Mukwonago
Cancer Center of Western Wisconsin
RECRUITING
New Richmond
Drexel Town Square Health Center
RECRUITING
Oak Creek
ProHealth Oconomowoc Memorial Hospital
RECRUITING
Oconomowoc
Vince Lombardi Cancer Clinic - Oshkosh
RECRUITING
Oshkosh
Aspirus Cancer Care - James Beck Cancer Center
RECRUITING
Rhinelander
Marshfield Medical Center-Rice Lake
RECRUITING
Rice Lake
Vince Lombardi Cancer Clinic-Sheboygan
RECRUITING
Sheboygan
Aspirus Cancer Care - Stevens Point
RECRUITING
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
RECRUITING
Stevens Point
Aurora Medical Center in Summit
RECRUITING
Summit
UW Cancer Center at ProHealth Care
RECRUITING
Waukesha
Aspirus Regional Cancer Center
RECRUITING
Wausau
Aurora Cancer Care-Milwaukee West
RECRUITING
Wauwatosa
Aurora West Allis Medical Center
RECRUITING
West Allis
Froedtert West Bend Hospital/Kraemer Cancer Center
RECRUITING
West Bend
Marshfield Medical Center - Weston
RECRUITING
Weston
Aspirus Cancer Care - Wisconsin Rapids
RECRUITING
Wisconsin Rapids
West Virginia
Edwards Comprehensive Cancer Center
RECRUITING
Huntington
Other Locations
Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
RECRUITING
Montreal
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
RECRUITING
Québec
University Health Network-Princess Margaret Hospital
RECRUITING
Toronto
Time Frame
Start Date: 2022-04-20
Estimated Completion Date: 2029-02-01
Participants
Target number of participants: 194
Treatments
Placebo_comparator: Arm I (placebo, SABR)
Patients receive placebo PO QD on days 1-180 and undergo SABR for 1-3 weeks in the absence of disease progression or unacceptable toxicity. Patients may also undergo bone scan, CT, MRI, PSMA PET/CT or PET/MRI, and/or fluciclovine F18 PET/CT or PET/MRI at time of disease progression. Patients may optionally undergo urine and blood sample collection throughout the trial.
Experimental: Arm II (relugolix, SABR)
Patients receive relugolix PO QD on days 1-180 and undergo SABR for 1-3 weeks in the absence of disease progression or unacceptable toxicity. Patients may also undergo bone scan, CT, MRI, PSMA PET/CT or PET/MRI, and/or fluciclovine F18 PET/CT or PET/MRI at time of disease progression. Patients may optionally undergo urine and blood sample collection throughout the trial.
Related Therapeutic Areas
Sponsors
Leads: NRG Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov