Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug combo aims to stall prostate cancer spread

NCT ID NCT04557059

Disease control Sponsor: Janssen Pharmaceutica N.V., Belgium Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This phase 3 study tests whether adding the drug apalutamide to standard radiotherapy and hormone therapy can delay cancer spread or death in 692 men with high-risk prostate cancer. Participants are randomly assigned to receive either the standard treatment alone or with apalutamide. The study uses advanced PET scans to track cancer progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Apalutamide (a hormone therapy drug)
What this could lead to
If successful, this could offer a new treatment option that delays cancer spread in high-risk prostate cancer patients.
What could go wrong
This is an early-stage trial, and results may not confirm benefit. Side effects from adding apalutamide could outweigh advantages.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

691 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Previously treated with radical prostatectomy with or without lymph node dissection and either: a) for biochemical recurrence after radical prostatectomy (RP): any post-operative prostate-specific antigen (PSA) measurement of less than (\<) 0.1 nanogram/milliliter (ng/mL) within 12 months after RP and without any PSA greater than and equal to (\>=) 0.1 ng/mL within the 4 to 8-week period after RP or b) for persistent PSA after RP: PSA \>=0.1 ng/mL within the 4 to 8-week period after RP, confirmed by additional measurement at least 3 weeks later * Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce * Results of the Prostate specific membrane antigen-positron emission tomography (PSMA-PET) at screening as determined by blinded independent, central review (BICR), must be: PSMA-PET-negative for any prostate cancer lesions (that is, no loco-regional lesion and no distant lesions); or PSMA-PET-positive for at least one loco-regional (pelvic) lesion without distant extra-pelvic lesion; or PSMA PET- positive for at least one loco--regional (pelvic) lesion with extra-pelvic lesion(s). * High risk of developing metastasis defined as; a) for biochemical recurrence after RP: pathological Gleason score greater than or equal to (\>=) 8 evaluated from prostate tissue specimen at radical prostatectomy, or prostate-specific antigen doubling time (PSADT) less than or equal to (\<=) 12 months at the time of screening; b) for persistent PSA after RP: pathological Gleason score \>=8, evaluated from prostate tissue specimen at radical prostatectomy * Participants with evidence of distant metastasis on screening PSMA-PET scan must have no evidence of prostate cancer metastases on screening CT/MRI of the chest/abdomen/pelvis, Technetium 99m \[99mTc\] whole-body bone scan. Participants with a single bone lesion on 99mTc whole-body bone scan should have confirmatory imaging by CT or MRI; if the confirmatory scan confirms the bone lesion, the participant should be excluded from the study. Conventional images (99mTc-bone scan and CT/MRI) from the screening will be evaluated locally before randomization * Eastern Cooperative Oncology Group Performance Status Grade 0 or 1 Exclusion Criteria: * History of pelvic radiation for malignancy * Previous treatment with androgen deprivation therapy (ADT) for prostate cancer * Previously treated for biochemical recurrence (BCR) or persistent PSA after RP (previous surgical treatment of one or more loco-regional lesions is allowed) * Prior treatment with a CYP17 inhibitor (example, oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any androgen receptor (AR) antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy * Known or suspected contraindications or hypersensitivity to apalutamide, Luteinizing Hormone-Releasing Hormone (LHRH) agonist or any of the components of the formulations * Prior chemotherapy for prostate cancer * Any evidence of prostate cancer metastasis on computed tomography/magnetic resonance imaging (CT/MRI) of the chest/abdomen/pelvis or 99mTc whole-body bone scan, at any time prior to screening

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Prostate adenocarcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer prostate neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostatic neoplasms

Contacts and locations

Locations

  • A.Z. Sint Jan

    Bruges, 8000, Belgium

  • Aalborg University Hospital

    Aalborg, 9000, Denmark

  • Aarhus University Hospital

    Aarhus N, 8200, Denmark

  • Adana Baskent Yuregir Hospital

    Adana, 01250, Turkey (Türkiye)

  • American Universitty of Beirut Medical Center

    Beirut, 1107 2020, Lebanon

  • Ankara University Medical Faculty

    Ankara, 06590, Turkey (Türkiye)

  • Arizona Urology Specialists

    Tucson, Arizona, 85741, United States

  • Arkansas Urology

    Little Rock, Arkansas, 72211, United States

  • Associated Medical Professionals of Ny

    Syracuse, New York, 13210, United States

  • Avix Investigacion Clinica S C

    Monterrey, 64623, Mexico

  • Az Groeninge

    Kortrijk, 8500, Belgium

  • Azienda Ospedaliera Sant Andrea

    Roma, 00189, Italy

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134, Italy

  • Bakirkoy Training and Research Hospital

    Istanbul, 34147, Turkey (Türkiye)

  • Budapesti Bajcsy Zsilinszky Korhaz es Rendelointezet

    Budapest, 1106, Hungary

  • Budapesti Uzsoki Utcai Korhaz

    Budapest, 1145, Hungary

  • Bundaberg Hospital

    Bundaberg, 4670, Australia

  • CUIMED - urologická ambulancia

    Bratislava, 851 05, Slovakia

  • Calvary Mater Newcastle

    Waratah, 2298, Australia

  • Centre Hospitalier du Nord

    Zghartā, 100, Lebanon

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020, Mexico

  • Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85 796, Poland

  • City Clinical Hospital #57

    Moscow, 105077, Russia

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Colorado Clinical Research

    Lakewood, Colorado, 80228, United States

  • Consultorio de Especialidad en Urologia Privado

    Durango, 34000, Mexico

  • Cuidados Oncologicos

    Querétaro, 76000, Mexico

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Dokuz Eylul Universitesi Arastirma ve Uygulama Hastanesi

    Izmir, 35340, Turkey (Türkiye)

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara, 06200, Turkey (Türkiye)

  • Epworth Healthcare

    East Melbourne, 3002, Australia

  • Eszak Budai Szent Janos Centrumkorhaz

    Budapest, 1125, Hungary

  • Fakultni nemocnice Plzen, Urologicka klinika

    Pilsen, 305 99, Czechia

  • Fakultni nemocnice v Motole

    Prague, 15006, Czechia

  • First Urology, PSC

    Jeffersonville, Indiana, 47130, United States

  • Fondazione Policlinico Tor Vergata

    Roma, 00133, Italy

  • Fund. Champalimaud

    Lisbon, 1400-038, Portugal

  • Genesis Care Hurstville

    Hurstville, 2220, Australia

  • GenesisCare Wembley

    Wembley, 6014, Australia

  • Gentofte Herlev Hospital

    Herlev, 2730, Denmark

  • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722, Turkey (Türkiye)

  • Hacettepe Universitesi Hastanesi

    Ankara, 06230, Turkey (Türkiye)

  • Helsinki University Hospital

    Helsinki, 00290, Finland

  • Hertzen Oncology Research Institute

    Moscow, 125284, Russia

  • Hervey Bay Hospital

    Bundaberg, 4670, Australia

  • Hosp Virgen de La Victoria

    Málaga, 29010, Spain

  • Hosp. Arquitecto Marcide

    Ferrol, 15405, Spain

  • Hosp. Clinico Univ. Lozano Blesa

    Zaragoza, 50009, Spain

  • Hosp. Cuf Tejo

    Lisbon, 1350-352, Portugal

  • Hosp. Da Luz Lisboa

    Lisbon, 1500 650, Portugal

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026, Spain

  • Hosp. Univ. de La Paz

    Madrid, 28046, Spain

  • Hosp. Virgen Del Rocio

    Seville, 41013, Spain

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407, Spain

  • Hosp. de Navarra

    Pamplona, 31008, Spain

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01421-000, Brazil

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060, Brazil

  • Hospital MAC Leon

    León, 37530, Mexico

  • Hospital Moinhos de Vento

    Porto Alegre, 90035-001, Brazil

  • Hospital Universitario Puerto Del Mar

    Cadiz, 11009, Spain

  • Hospital das Clínicas - Universidade Federal de Minas Gerais

    Belo Horizonte, 30130 100, Brazil

  • Houston Metro Urology

    Houston, Texas, 77027, United States

  • I.M. Sechenov First Moscow State Medical University

    Moscow, 119991, Russia

  • IDOR - Regional Bahia

    Salvador, 41253-190, Brazil

  • Ipo Lisboa

    Lisbon, 1099-023, Portugal

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170, Brazil

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34096, Turkey (Türkiye)

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144, Italy

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040, Russia

  • Jahn Ferenc Del-pesti Korhaz es Rendelointezet

    Budapest, 1204, Hungary

  • Kartal Dr Lutfi Kirdar Egitim ve Arastirma Hastanesi

    Istanbul, 34890, Turkey (Türkiye)

  • King Hussein Cancer Center

    Amman, 0000, Jordan

  • Klinikum rechts der Isar - der Technischen Universität München

    München, 81675, Germany

  • Koc University, School of Medicine, Koc University Hospital

    Istanbul, 34010, Turkey (Türkiye)

  • Leningrad Regional Oncology Dispensary

    Saint Petersburg, 191104, Russia

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59075-740, Brazil

  • MILAB s.r.o.

    Prešov, 08001, Slovakia

  • Macquarie University Hospital

    North Ryde, 2109, Australia

  • Medizinische Universitaet Wien

    Vienna, 1090, Austria

  • Memorial Ankara Hastanesi

    Ankara, 06520, Turkey (Türkiye)

  • Michigan Institute of Urology

    Troy, Michigan, 48084, United States

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Multifunctional clinical medical center 'Medical city'

    Tyumen, 625041, Russia

  • NU-MED Grupa S.A Centrum Radioterapii i Onkologii

    Elblag, 82-300, Poland

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02 781, Poland

  • Notre Dame De Secours

    Byblos, 3, Lebanon

  • Núcleo de Pesquisa São Camilo

    São Paulo, 04014-002, Brazil

  • Oncocenter

    Puebla City, 72530, Mexico

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250-905, Brazil

  • Oncologia Integral Satelite

    Naucalpan, 53100, Mexico

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, 4020, Austria

  • Oregon Urology Institute

    Springfield, Oregon, 97477, United States

  • Orszagos Onkologiai Intezet

    Budapest, 1122, Hungary

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Oulu University Hospital

    Oulu, 90220, Finland

  • Privátna urologická ambulancia

    Trenčín, 911 01, Slovakia

  • Prostatacancercentrum

    Stockholm, 112 19, Sweden

  • Péterfy Sándor utcai Kórház

    Budapest, 1076, Hungary

  • Radioterapia Oncologica, A.O.U. San'T Orsola

    Bologna, 40138, Italy

  • Radomskie Centrum Onkologii

    Radom, 26-600, Poland

  • Rigshospitalet

    Copenhagen N, 2200, Denmark

  • SHI Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102, Russia

  • SPb SBIH 'City Clinical Oncological Dispensary'

    Saint Petersburg, 197022, Russia

  • Sakarya Üniversitesi Tıp Fakültesi Hastanesi

    Sakarya, 54187, Turkey (Türkiye)

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652 900, Brazil

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 901, Brazil

  • Sodersjukhuset

    Stockholm, 11883, Sweden

  • Spokane Urology

    Spokane, Washington, 99202, United States

  • St Georges Hospital university medical centre

    Beirut, 11 00 2807, Lebanon

  • St Vincent's Hospital - Melbourne

    Fitzroy, 3065, Australia

  • Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer

    Braunschweig, 38126, Germany

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734, Poland

  • Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie

    Koszalin, 75 581, Poland

  • Szpitale Pomorskie Sp z o o

    Gdynia, 81 519, Poland

  • Tampere University Hospital

    Tampere, 33521, Finland

  • The Urology Group

    Cincinnati, Ohio, 45212, United States

  • Turku University Hospital

    Turku, 20520, Finland

  • UZ Gent

    Ghent, 9000, Belgium

  • Uls Lisboa Ocidental - Hosp. Sao Francisco Xavier

    Lisbon, 1449-005, Portugal

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1649 035, Portugal

  • Uls Santo Antonio - Hosp. Santo Antonio

    Porto, 4099-001, Portugal

  • Uls de Entre Douro E Vouga - Hosp. Sao Sebastiao

    Santa Maria da Feira, 4520-211, Portugal

  • Universitaetsklinikum Muenster

    Münster, 48149, Germany

  • Universitaetsklinikum Salzburg Landeskrankenhaus

    Salzburg, 5020, Austria

  • Universitatsklinikum Carl Gustav Carcus Dresden

    Dresden, 01307, Germany

  • Universitatsklinikum Essen

    Essen, D-45147, Germany

  • Univerzitná nemocnica Martin

    Martin, 036 59, Slovakia

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 952, Poland

  • Urocentrum Praha

    Prague, 120 00, Czechia

  • Uroexam s.r.o.

    Nitra, 94901, Slovakia

  • Urological Research Network

    Hialeah, Florida, 33016, United States

  • Urologicka ambulancia e.cho Poprad, s.r.o

    Poprad, 05801, Slovakia

  • Urologicka klinika 1 LF UK a VFN

    Prague, 120 00, Czechia

  • Urologiska Mottagningen

    Malmö, 205 02, Sweden

  • Urology Austin

    Austin, Texas, 78745, United States

  • Vaasa Central Hospital

    Vaasa, 65130, Finland

  • Vivantes Klinikum Am Urban

    Berlin, 10967, Germany

  • Východoslovenský Onkologický Ústav

    Košice, 04191, Slovakia

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

    Lodz, 93 513, Poland

  • ZAS Augustinus

    Antwerp, 2610, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.