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Prostate CancerPhase 3AFFINITYNCT01578655

Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer

A Phase 3 study testing cabazitaxel, prednisone and custirsen sodium in people with Prostate Cancer, run by Achieve Life Sciences at 94 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Prostate Cancer
What is being tested?
cabazitaxel, prednisone and custirsen sodium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
630 participants
Where
94 sitesin 8 countries
Study dates
Aug 2012to Jul 2016
Phase
Phase 3
Are there results?
None posted in the registry

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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histological or cytological diagnosis of adenocarcinoma of the prostate
  • Metastatic disease on chest, abdominal, or pelvic CT scan and/or bone scan
  • Previous first-line treatment for CRPC with a docetaxel-containing regimen
  • Current progressive disease
  • Increasing serum PSA level (for patients who progress based only on increasing serum PSA level, a minimum starting value of 5.0 ng/mL is required)
  • Baseline laboratory values as defined
Show all 17Show fewer
  • Willing to continue primary androgen suppression with gonadotropin-releasing hormone (GnRH) analogues (unless treated with bilateral orchiectomy)
  • Karnofsky score ≥70%
  • At least 21 days have passed since completing radiotherapy
  • At least 21 days have passed since receiving any investigational agent at the time of randomization
  • At least 21 days have passed since major surgery
  • Recovered from any docetaxel therapy-related neuropathy to ≤grade 1 at the time of randomization
  • Recovered from all therapy related toxicity to ≤grade 2 (except alopecia, anemia, and any signs or symptoms of androgen deprivation therapy) at the time of randomization
  • Able to tolerate a starting dose of 25 mg/m² cabazitaxel
  • Willing to not add, delete, or change current bisphosphonate or denosumab usage
  • Able to tolerate oral prednisone at 10 mg per day
  • Competent to provide written informed consent

Who cannot join

  • Received any other cytotoxic chemotherapy beyond the first-line docetaxel-containing regimen as treatment for prostate cancer
  • Received prior radioisotope with strontium 89 or samarium 153
  • Received any cycling, intermittent, or continuous hormonal treatment within 21 days prior to randomization with the exception of the continuous GnRH analogues (prior treatment with abiraterone or MDV3100 is allowed as long as 21 days have passed since last dose)
  • Participated in a prior Phase 3 clinical study evaluating custirsen regardless of study arm assignment
  • Requiring ongoing treatment during the study with medications known to be either strong CYP3A inhibitors or strong CYP3A inducers
  • History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated
Show all 11Show fewer
  • Current symptomatic cord compression requiring surgery or radiation therapy
  • Active second malignancy (except non melanomatous skin or superficial bladder cancer) defined in general as requiring anticancer therapy or at high risk of recurrence during the study
  • Uncontrolled medical condition or significant concurrent illness that in the opinion of the Investigator would preclude protocol therapy
  • Known severe hypersensitivity to taxanes or polysorbate 80-containing drugs
  • Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device

Trial locations and contacts

94 sites in 8 countries.

94 sites in 8 countries

United States35 sites

  • University of Michigan Health System

    Ann Arbor, Michigan

  • Oncology Hematology Care, Inc.

    Blue Ash, Ohio

  • The Center for Hematology-Oncology

    Boca Raton, Florida

  • Boston University Medical Center

    Boston, Massachusetts

  • Rocky Mountain Cancer Center

    Boulder, Colorado

  • Blumenthal Cancer Center

    Charlotte, North Carolina

  • Chattanooga Oncology and Hematology Associates

    Chattanooga, Tennessee

  • South Carolina Oncology Associates

    Columbia, South Carolina

  • The Mark H. Zangmeister Center

    Columbus, Ohio

  • Texas Oncology, PA

    Dallas, Texas

  • Karmanos Cancer Institute

    Detroit, Michigan

  • Florida Cancer Specialists

    Fort Myers, Florida

  • Cancer Centers of the Carolinas

    Greenville, South Carolina

  • Hartford Hospital

    Hartford, Connecticut

  • Florida Cancer Specialists

    Inverness, Florida

  • Monter Cancer Center

    Lake Success, New York

  • Georgia Cancer Specialists, P.C.

    Marietta, Georgia

  • Prostate Oncology Specialists

    Marina del Rey, California

  • The West Clinic

    Memphis, Tennessee

  • Tennessee Oncology, PLLC

    Nashville, Tennessee

  • Smilow Cancer Hospital at Yale New Haven Hospital

    New Haven, Connecticut

  • Virginia Oncology Associates

    Norfolk, Virginia

  • Urology Cancer Center and GU Research Network

    Omaha, Nebraska

  • Oregon Health and Science University

    Portland, Oregon

  • Cancer Centers of North Carolina

    Raleigh, North Carolina

  • Virginia Cancer Institute

    Richmond, Virginia

  • University of California Davis Medical Center

    Sacramento, California

  • Utah Cancer Specialists

    Salt Lake City, Utah

  • Sharp Health Care

    San Diego, California

  • California Pacific Medical Center Research Institute

    San Francisco, California

  • Washington University School of Medicine

    St Louis, Missouri

  • SUNY Upstate Medical University

    Syracuse, New York

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida

  • Albert Einstein Medical Center

    The Bronx, New York

  • Cancer Center of Kansas

    Wichita, Kansas

Other trials in United States

Russia12 sites

  • S Inst Hlth Altay Reg Onc Disp

    Barnaul

  • Ivanovo Reg Oncology Centre

    Ivanovo, Ivanovo Oblast

  • Cancer Research Center na NN Blokhin

    Moscow, Moscow

  • Hertzen Rsrch Inst of Oncology

    Moscow, Moscow

  • Russian Research Center of Radiology

    Moscow

  • Urology Research Institute

    Moscow

  • State Healthcare Inst Omsk Reg

    Omsk

  • Petrov Research Oncology Institute

    Saint Petersburg

  • Saint Petersburg City Oncological Dispensary

    Saint Petersburg

  • Stavropol Reg Oncology Ctr

    Stavropol

  • Volgograd Regional Oncological Dispensary

    Volzhsky, Volgograd Oblast

  • Sverdlovsk Reg Clin Hosp#1

    Yekaterinburg, Ural

Other trials in Russia

Australia11 sites

  • Box Hill Hospital

    Box Hill, Victoria

  • Haematology and Oncology Clinics of Australia

    Brisbane, Queensland

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales

  • The Canberra Hospital

    Garran, Australian Capital Territory

  • Austin Health

    Heidelberg, Victoria

  • Royal Hobart Hospital

    Hobart, Tasmania

  • St George Public Hospital

    Kogarah, New South Wales

  • Epworth Healthcare

    Richmond, Victoria

  • Royal North Shore Hospital

    Saint Leonards, New South Wales

  • Westmead Hospital

    Westmead, New South Wales

  • The Queen Elizabeth Hospital

    Woodville South, South Australia

Other trials in Australia

France10 sites

  • Centre François Baclesse

    Caen, Basse-Normandie

  • Centre Léon Bérard

    Lyon Cédex 08, Auvergne-Rhône-Alpes

  • Institut Paoli Calmettes

    Marseille, Marseille

  • Centre Antoine Lacassagne

    Nice, Provence-Alpes-Côte d'Azur Region

  • Hôpital Saint Louis

    Paris, Île-de-France Region

  • Institut Curie

    Paris, Île-de-France Region

  • Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie

    Poitiers, Poitou-Charentes

  • Institut Jean-Godinot

    Reims, Champagne-Ardenne

  • Institut de Cancérologie de l'Ouest - René Gauducheau

    Saint-Herblain, Pays de la Loire Region

  • Institut Gustave Roussy

    Villejuif, Île-de-France Region

Other trials in France

United Kingdom9 sites

  • Cancer Research UK

    Birmingham, England

  • Addenbrookes Hospital Cambridge

    Cambridge, England

  • Beatson Cancer Centre, Glasgow

    Glasgow, Scotland

  • U of Surrey Post Grad Med

    Guildford, England

  • Christie Hospital NHS Foundation Trust

    Manchester, England

  • Clatterbridge Centre for Oncology NHS Foundation Trust

    Metropolitan Borough of Wirral, England

  • Nottingham City Hospital NHS Trust

    Nottingham, England

  • The Royal Marsden Hospital

    Surrey, England

  • Musgrove Park Hospital

    Taunton, England

Other trials in United Kingdom

Canada8 sites

  • Cross Cancer Institute

    Edmonton, Alberta

  • Juravinski Cancer Centre

    Hamilton, Ontario

  • London Health Sciences Center

    London, Ontario

  • CHUM-Hospital Notre-Dame

    Montreal, Quebec

  • R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa

    Oshawa, Ontario

  • The Ottawa Hospital Regional Cancer Centre

    Ottawa, Ontario

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • British Columbia Cancer Agency

    Vancouver, British Columbia

Other trials in Canada

Hungary5 sites

  • Országos Onkológiai Intézet

    Budapest, Budapest

  • Semmelweis Egyetem Általános Orvostudományi Kar

    Budapest, Budapest

  • Pándy Kálmán Megyei Kórház

    Gyula, Bekes County

  • Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház

    Miskolc, Borsod-Abauj Zemplen county

  • Szegedi Tudományegyetem, Onkoterápiás Klinika

    Szeged, Csongrád megye

Other trials in Hungary

Czechia4 sites

  • Fakultni nemo Hradec Králové

    Hradec Králové

  • Krajská nemocnice Liberec a.s.

    Liberec, Liberec

  • University Hospital Olomouc

    Olomouc

  • Krajská nemo. T.Bati, a. s.

    Zlín, Severomoravsky Kraj

Other trials in Czechia

About this study

Official title: A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination With Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men With Metastatic Castrate Resistant Prostate Cancer (AFFINITY)

This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms.

Read the detailed description

Until recently, options for second-line chemotherapy in CRPC have included docetaxel retreatment, mitoxantrone, or other chemotherapies, without proven clinical benefit. In 2010, a Phase 3 second-line chemotherapy trial (TROPIC) showed a survival advantage for cabazitaxel, a semi-synthetic taxane selected to overcome the emergence of taxane resistance, when compared to mitoxantrone.

Clusterin is a stress-activated cytoprotective chaperone up-regulated by a variety of anti-cancer therapies that confers treatment resistance when over-expressed. Inhibition of clusterin expression using custirsen has been shown to enhance tumor cell death following treatment with chemotherapy.

The clinical activity of custirsen in combination with the taxane docetaxel has been shown in two Phase 2 studies. Given the results observed using a taxane as either first-line or second-line chemotherapy in CRPC, combination with custirsen may decrease taxane resistance and enhance the survival benefit of taxane therapy. Thus, a combination of custirsen with cabazitaxel may further enhance survival in second-line taxane chemotherapy for CRPC.

Conditions
Prostate Cancer
Being tested
cabazitaxel, prednisone, custirsen sodium
Keywords
custirsen sodium, prostate cancer, metastatic castrate resistant prostate cancer, overall survival
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cabazitaxelDrug

    Cabazitaxel (25mg/m² IV) is administered on day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles

  • prednisoneDrug

    Prednisone (10 mg PO) is administered daily until disease progression, unacceptable toxicity, or completion of 10 cycles

  • custirsen sodiumDrug

    Also called OGX-011, TV-1011

    Custirsen is administered as 3 loading doses (640 mg IV each) within 9 days, followed by weekly custirsen (640 mg IV) during each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles

Study groups in NCT01578655
Study groupRoleWhat they receive
Cabazitaxel plus CustirsenExperimentalcabazitaxel, prednisone, and custirsen sodium
Receives: Drug: cabazitaxel; Drug: prednisone; Drug: custirsen sodium
CabazitaxelActive comparatorcabazitaxel and prednisone
Receives: Drug: cabazitaxel; Drug: prednisone

What is being measured

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

  1. Survival in the intent-to-treat population

    To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone).

    Measured: 3.4 years

  2. Survival in the poor-prognosis patient population

    To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) and identified as having poor prognosis is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone) and identified as having poor prognosis.

    Measured: 2.7 years

Secondary outcomes (1)

  1. Progression-free survival at Day 140

    To compare the arms with respect to the proportion of patients having a milestone Day 140 status of Alive Without Event (within the window of Day 125-155 post-randomization). An event is defined as disease progression or death on or before Day 140.

    Measured: From randomization to Day 125 to Day 155

Timeline

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

  1. First posted17 Apr 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
630 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01578655
Sponsor's protocol ID
OGX-011-12
Acronym
AFFINITY
Status last verified
Oct 2016
First submitted
9 Apr 2012
Last updated
12 Oct 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Saad F, Hotte S, North S, Eigl B, Chi K, Czaykowski P, Wood L, Pollak M, Berry S, Lattouf JB, Mukherjee SD, Gleave M, Winquist E; Canadian Uro-Oncology Group. Randomized phase II trial of Custirsen (OGX-011) in combination with docetaxel or mitoxantrone as second-line therapy in patients with metastatic castrate-resistant prostate cancer progressing after first-line docetaxel: CUOG trial P-06c. Clin Cancer Res. 2011 Sep 1;17(17):5765-73. doi: 10.1158/1078-0432.CCR-11-0859. Epub 2011 Jul 25.

    PubMed 21788353

  • Chi KN, Hotte SJ, Yu EY, Tu D, Eigl BJ, Tannock I, Saad F, North S, Powers J, Gleave ME, Eisenhauer EA. Randomized phase II study of docetaxel and prednisone with or without OGX-011 in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2010 Sep 20;28(27):4247-54. doi: 10.1200/JCO.2009.26.8771. Epub 2010 Aug 23.

    PubMed 20733135

  • Beer TM, Hotte SJ, Saad F, Alekseev B, Matveev V, Flechon A, Gravis G, Joly F, Chi KN, Malik Z, Blumenstein B, Stewart PS, Jacobs CA, Fizazi K. Custirsen (OGX-011) combined with cabazitaxel and prednisone versus cabazitaxel and prednisone alone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel (AFFINITY): a randomised, open-label, international, phase 3 trial. Lancet Oncol. 2017 Nov;18(11):1532-1542. doi: 10.1016/S1470-2045(17)30605-8. Epub 2017 Oct 9.

    PubMed 29033099

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cabazitaxel, prednisone and custirsen sodium in people with Prostate Cancer, run by Achieve Life Sciences at 94 sites in 8 countries.

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 17 inclusion and 11 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: finished, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Russia, Australia, France, United Kingdom and 3 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Survival in the intent-to-treat population (time frame: 3.4 years). The study lists 2 primary outcomes in all. 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 NCT01578655, which also lists 3 linked publications.

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 12 Oct 2016.

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