Castration-Resistant Prostate CancerPREDICTNCT01981109

Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer

An observational study of Castration-Resistant Prostate Cancer, run by Dendreon at 58 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The primary purpose of this research is to describe patient characteristics predictive of an imaging study positive for distant metastases in patients with castration-resistant prostate cancer and no known distant metastases. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Castration-Resistant Prostate Cancer
How many people: 225 participants
Where: 58 sitesUnited States
Study dates: Jan 2012to Jul 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Study population: Men with Castration-Resistant Prostate Cancerand no known M1 disease who are at least 18 years of age at the time of screening are eligible.

Who may be able to join

Written informed consent obtained prior to the initiation of study procedures.
Men ≥ 18 years of age.
Histologically documented prostatic adenocarcinoma.
History of Castration-Resistant Prostate Cancer.

Who cannot join

Known M1 disease.
Undergone imaging study for metastatic prostate cancer ≤ 3 months.
ECOG performance status ≥ 3.
Known malignant pleural effusions or ascites.
Current or prior treatment with investigational therapy for M0 Castration-Resistant Prostate Cancer (Taxotere (docetaxel), Provenge® (sipuleucel-T), Zytiga (abiraterone acetate), Xtandi (enzalutamide), Jevtana (cabazitaxel), or Xofigo (radium Ra 223 dichloride).

Trial locations and contacts

58 sites in 1 country.

City, postcode or hospital

58 sites in 1 country

United States58 sites

Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99503
Sequoia Urology Center
Atherton, California
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, 19004
Urology Health Specialists, LLC
Bryn Mawr, Pennsylvania, 19010
Urology Clinics of North Texas
Dallas, Texas, 75231
The Urology Center of Colorado
Denver, Colorado, 80211
Durham Veterans Affairs Medical Center
Durham, North Carolina, 27710
National Translational Research Group
East Setauket, New York
Urology Center Research Institute
Englewood, New Jersey, 07631
Central Ohio Urology Group
Gahanna, Ohio
Carolina Urology Partners
Gastonia, North Carolina, 28054
The Conrad Pearson Clinic
Germantown, Tennessee
Mid Atlantic Urology Associates
Greenbelt, Maryland, 20770
Houston Metro Urology
Houston, Texas, 77027
UT Memorial Hermann Cancer Center
Houston, Texas
1st Urology, PSC
Jeffersonville, Indiana, 47130
Tennessee Urology Asociates
Knoxville, Tennessee
Comprehensive Urologic Care, SC
Lake Barrington, Illinois, 60010
Lancaster Urology
Lancaster, Pennsylvania, 17604
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510
Jewish Hospital
Louisville, Kentucky, 40245
Prostate Oncology Specialist, Inc.
Marina del Rey, California, 90292
Uro Partners/ RMD Clinical Research
Melrose Park, Illinois, 60160
Idaho Urologic Institute
Meridian, Idaho, 83642
Urology Center of South Florida
Miami, Florida
Clinical Research Solutions
Middleburg Heights, Ohio
Delaware Valley Urology, LLC
Mount Laurel, New Jersey, 08054
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Urology Associates, P.C.
Nashville, Tennessee, 37209
Tulane University
New Orleans, Louisiana, 70112
Integrated Medical Professionals, PLLC
North Hills, New York, 11042
Stepherson Cancer Center
Oklahoma City, Oklahoma
Kansas City Urology Care, PA
Overland Park, Kansas, 66211
Associated Urological Specialists, LLC
Palos Heights, Illinois, 60463
Advanced Urology, P.C
Parker, Colorado, 80134
Metro Urology
Plymouth, Minnesota, 55441
Portland Veterans Administration Medical Center
Portland, Oregon
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601
Virginia Urology
Richmond, Virginia, 23235
Sutter Medical Group
Sacramento, California
Oncology San Antonio Research LLC
San Antonio, Texas, 78240
Genesis Research
San Diego, California, 92123
Highland Clinic
Shreveport, Louisiana, 71106
Regional Urology, LLC
Shreveport, Louisiana, 71106
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628
Medical Oncology Associates
Spokane, Washington, 99208
Oregon Urology Institute
Springfield, Oregon, 97477
Saint Louis VAMS
St Louis, Missouri
Associated Medical Professionals of NY, PLLC
Syracuse, New York, 13210
Urology Associates of San Luis Obispo
Templeton, California, 93465
Montefiore Medical Center
The Bronx, New York, 10467
Chesapeake Urology Research Associates
Towson, Maryland, 21204
Michigan Institute of Urology
Troy, Michigan, 48084
Urological Associate of Southern Arizona
Tucson, Arizona
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23642
Howard University Hospital
Washington D.C., District of Columbia, 20060
Cancer Center of Kansas
Wichita, Kansas, 67214
Metro Urology
Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer

Conditions: Castration-Resistant Prostate Cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration
The primary endpoint for the study will be the occurrence of an imaging study at baseline that is positive for M1 (yes or no) among all patients in the primary analysis population.The primary analysis population consists of patients who had a current diagnosis of having non metastatic (M0) disease at baseline. These patients underwent imaging scans at baseline and were assessed for metastatic (M1) versus non metastatic (M0) disease.
Measured: Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jul 2017

First posted11 Nov 2013 (estimated)
Study startJan 2012
Primary completionJul 2017
Study completionJul 2017

Why it stopped: Administrative reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Castration-Resistant Prostate CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01981109
Sponsor's protocol ID: P12-1
Acronym: PREDICT
Status last verified: Jul 2019
First submitted: 28 Oct 2013
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
Pluvicto Real-world Investigation in Survival in Metastatic CRPC
Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
Metastatic Castrate Resistant Prostate Cancer (mCRPC)

All Castration-Resistant Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT01981109
Acronym / sponsor ID: PREDICT / P12-1
Conditions: Castration-Resistant Prostate Cancer
Study type: Observational
Recruitment status: TerminatedReason stopped: Administrative reasons
Enrolment: 225 participants (actual)
Lead sponsor: DendreonIndustry (pharma, biotech, devices)
Study start: Jan 2012 (actual)
Primary completion: Jul 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 11 Nov 2013 (estimated)
Results: Posted 28 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Men with Castration-Resistant Prostate Cancerand no known M1 disease who are at least 18 years of age at the time of screening are eligible.

Key inclusion criteria (4 listed)

Written informed consent obtained prior to the initiation of study procedures.
Men ≥ 18 years of age.
Histologically documented prostatic adenocarcinoma.
History of Castration-Resistant Prostate Cancer.

Key exclusion criteria (5 listed)

Known M1 disease.
Undergone imaging study for metastatic prostate cancer ≤ 3 months.
ECOG performance status ≥ 3.
Known malignant pleural effusions or ascites.
Current or prior treatment with investigational therapy for M0 Castration-Resistant Prostate Cancer (Taxotere (docetaxel), Provenge® (sipuleucel-T), Zytiga (abiraterone acetate), Xtandi (enzalutamide), Jevtana (cabazitaxel), or Xofigo (radium Ra 223 dichloride).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration
Time frame: Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan.
The primary endpoint for the study will be the occurrence of an imaging study at baseline that is positive for M1 (yes or no) among all patients in the primary analysis population.The primary analysis population consists of patients who had a current diagnosis of having non metastatic (M0) disease at baseline. These patients underwent imaging scans at baseline and were assessed for metastatic (M1) versus non metastatic (M0) disease.

Results and safety

Results posted to the registry on 28 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sipuleucel-T	225	1

Primary outcome: Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration

Time frame: Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan.. Mean (Standard Deviation). Unit: years

Measure	M0- No Distant Metastases n = 151	M1-Distant Metastases n = 55
Value	10.9 (6.4)	8.8 (5.9)

Population analysed: There were 206 patients at baseline that had a valuable data that were assessed. The results were 151 patients that had non-metastatic (M0) and 55 patients that had metastatic disease (M1) disease. The study terminated early therefore no further statistical analysis was performed.

Adverse events

Time frame: Adverse Events and Serious Adverse Events were not collected in this trial as investigational treatment was not administered in this study. Patients received commercial Provenge® (sipuleucel-T), therefore all SAEs were reported to the Safety Reporting group following full prescribing directions.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sipuleucel-T	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): The study was designed to analyze 1200 patients. Early termination resulted in only 206 patients reporting a definitive diagnosis per imaging scan. Given this much smaller number of patients, the analyses do not provide reliable results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Castration-Resistant Prostate Cancer

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
Pluvicto Real-world Investigation in Survival in Metastatic CRPC
Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruce Brown, MD study director

Dendreon Pharmaceuticals, LLC

58 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Castration-Resistant Prostate Cancer, run by Dendreon at 58 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration (time frame: Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01981109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.