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Prostatic NeoplasmsPhase 3PRIMORDIUMNCT04557059

A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer

A Phase 3 study testing Radiotherapy, LHRHa and Apalutamide in people with Prostatic Neoplasms, run by Janssen Pharmaceutica N.V., Belgium at 141 sites in 21 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Radiotherapy, LHRHa and Apalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
691 participants
Where
141 sitesin 21 countries
Study dates
12 Nov 2020to 15 Sep 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

141 sites in 21 countries.

141 sites in 21 countries

United States13 sites

  • Urology Austin

    Austin, Texas, 78745

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • The Urology Group

    Cincinnati, Ohio, 45212

  • Urological Research Network

    Hialeah, Florida, 33016

  • Houston Metro Urology

    Houston, Texas, 77027

  • First Urology, PSC

    Jeffersonville, Indiana, 47130

  • Colorado Clinical Research

    Lakewood, Colorado, 80228

  • Arkansas Urology

    Little Rock, Arkansas, 72211

  • Spokane Urology

    Spokane, Washington, 99202

  • Oregon Urology Institute

    Springfield, Oregon, 97477

  • Associated Medical Professionals of Ny

    Syracuse, New York, 13210

  • Michigan Institute of Urology

    Troy, Michigan, 48084

  • Arizona Urology Specialists

    Tucson, Arizona, 85741

Other trials in United States

Turkey (Türkiye)12 sites

  • Adana Baskent Yuregir Hospital

    Adana, 01250

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara, 06200

  • Hacettepe Universitesi Hastanesi

    Ankara, 06230

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Ankara University Medical Faculty

    Ankara, 06590

  • Koc University, School of Medicine, Koc University Hospital

    Istanbul, 34010

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34096

  • Bakirkoy Training and Research Hospital

    Istanbul, 34147

  • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • Kartal Dr Lutfi Kirdar Egitim ve Arastirma Hastanesi

    Istanbul, 34890

  • Dokuz Eylul Universitesi Arastirma ve Uygulama Hastanesi

    Izmir, 35340

  • Sakarya Üniversitesi Tıp Fakültesi Hastanesi

    Sakarya, 54187

Other trials in Turkey (Türkiye)

Brazil11 sites

  • Hospital das Clínicas - Universidade Federal de Minas Gerais

    Belo Horizonte, 30130 100

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59075-740

  • Hospital Moinhos de Vento

    Porto Alegre, 90035-001

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250-905

  • IDOR - Regional Bahia

    Salvador, 41253-190

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 901

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01421-000

  • Núcleo de Pesquisa São Camilo

    São Paulo, 04014-002

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652 900

Other trials in Brazil

Spain11 sites

  • Hospital Universitario Puerto Del Mar

    Cadiz, 11009

  • Hosp. Arquitecto Marcide

    Ferrol, 15405

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. de La Paz

    Madrid, 28046

  • Hosp Virgen de La Victoria

    Málaga, 29010

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp. de Navarra

    Pamplona, 31008

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

  • Hosp. Clinico Univ. Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Poland9 sites

  • Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85 796

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

    Elblag, 82-300

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 952

  • Szpitale Pomorskie Sp z o o

    Gdynia, 81 519

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734

  • Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie

    Koszalin, 75 581

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

    Lodz, 93 513

  • Radomskie Centrum Onkologii

    Radom, 26-600

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02 781

Other trials in Poland

Australia8 sites

  • Bundaberg Hospital

    Bundaberg, 4670

  • Hervey Bay Hospital

    Bundaberg, 4670

  • Epworth Healthcare

    East Melbourne, 3002

  • St Vincent's Hospital - Melbourne

    Fitzroy, 3065

  • Genesis Care Hurstville

    Hurstville, 2220

  • Macquarie University Hospital

    North Ryde, 2109

  • Calvary Mater Newcastle

    Waratah, 2298

  • GenesisCare Wembley

    Wembley, 6014

Other trials in Australia

Portugal8 sites

  • Ipo Lisboa

    Lisbon, 1099-023

  • Hosp. Cuf Tejo

    Lisbon, 1350-352

  • Fund. Champalimaud

    Lisbon, 1400-038

  • Uls Lisboa Ocidental - Hosp. Sao Francisco Xavier

    Lisbon, 1449-005

  • Hosp. Da Luz Lisboa

    Lisbon, 1500 650

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1649 035

  • Uls Santo Antonio - Hosp. Santo Antonio

    Porto, 4099-001

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

    Santa Maria da Feira, 4520-211

Other trials in Portugal

Russia8 sites

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • City Clinical Hospital #57

    Moscow, 105077

  • I.M. Sechenov First Moscow State Medical University

    Moscow, 119991

  • Hertzen Oncology Research Institute

    Moscow, 125284

  • Leningrad Regional Oncology Dispensary

    Saint Petersburg, 191104

  • SPb SBIH 'City Clinical Oncological Dispensary'

    Saint Petersburg, 197022

  • Multifunctional clinical medical center 'Medical city'

    Tyumen, 625041

  • SHI Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102

Other trials in Russia

Hungary7 sites

  • Péterfy Sándor utcai Kórház

    Budapest, 1076

  • Budapesti Bajcsy Zsilinszky Korhaz es Rendelointezet

    Budapest, 1106

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Eszak Budai Szent Janos Centrumkorhaz

    Budapest, 1125

  • Budapesti Uzsoki Utcai Korhaz

    Budapest, 1145

  • Jahn Ferenc Del-pesti Korhaz es Rendelointezet

    Budapest, 1204

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

Other trials in Hungary

Mexico7 sites

  • Consultorio de Especialidad en Urologia Privado

    Durango, 34000

  • Hospital MAC Leon

    León, 37530

  • Avix Investigacion Clinica S C

    Monterrey, 64623

  • Oncologia Integral Satelite

    Naucalpan, 53100

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020

  • Oncocenter

    Puebla City, 72530

  • Cuidados Oncologicos

    Querétaro, 76000

Other trials in Mexico

Slovakia7 sites

  • CUIMED - urologická ambulancia

    Bratislava, 851 05

  • Východoslovenský Onkologický Ústav

    Košice, 04191

  • Univerzitná nemocnica Martin

    Martin, 036 59

  • Uroexam s.r.o.

    Nitra, 94901

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

    Poprad, 05801

  • MILAB s.r.o.

    Prešov, 08001

  • Privátna urologická ambulancia

    Trenčín, 911 01

Other trials in Slovakia

Germany6 sites

  • Vivantes Klinikum Am Urban

    Berlin, 10967

  • Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer

    Braunschweig, 38126

  • Universitatsklinikum Carl Gustav Carcus Dresden

    Dresden, 01307

  • Universitatsklinikum Essen

    Essen, D-45147

  • Klinikum rechts der Isar - der Technischen Universität München

    München, 81675

  • Universitaetsklinikum Muenster

    Münster, 48149

Other trials in Germany

Italy6 sites

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

    Bologna, 40138

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

  • Ospedale San Raffaele

    Milan, 20132

  • Fondazione Policlinico Tor Vergata

    Roma, 00133

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144

  • Azienda Ospedaliera Sant Andrea

    Roma, 00189

Other trials in Italy

Finland5 sites

  • Helsinki University Hospital

    Helsinki, 00290

  • Oulu University Hospital

    Oulu, 90220

  • Tampere University Hospital

    Tampere, 33521

  • Turku University Hospital

    Turku, 20520

  • Vaasa Central Hospital

    Vaasa, 65130

Other trials in Finland

Belgium4 sites

  • ZAS Augustinus

    Antwerp, 2610

  • A.Z. Sint Jan

    Bruges, 8000

  • UZ Gent

    Ghent, 9000

  • Az Groeninge

    Kortrijk, 8500

Other trials in Belgium

Czechia4 sites

  • Fakultni nemocnice Plzen, Urologicka klinika

    Pilsen, 305 99

  • Urocentrum Praha

    Prague, 120 00

  • Urologicka klinika 1 LF UK a VFN

    Prague, 120 00

  • Fakultni nemocnice v Motole

    Prague, 15006

Other trials in Czechia

Denmark4 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus N, 8200

  • Rigshospitalet

    Copenhagen N, 2200

  • Gentofte Herlev Hospital

    Herlev, 2730

Other trials in Denmark

Lebanon4 sites

  • St Georges Hospital university medical centre

    Beirut, 11 00 2807

  • American Universitty of Beirut Medical Center

    Beirut, 1107 2020

  • Notre Dame De Secours

    Byblos, 3

  • Centre Hospitalier du Nord

    Zghartā, 100

Other trials in Lebanon

Austria3 sites

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, 4020

  • Universitaetsklinikum Salzburg Landeskrankenhaus

    Salzburg, 5020

  • Medizinische Universitaet Wien

    Vienna, 1090

Other trials in Austria

Sweden3 sites

  • Urologiska Mottagningen

    Malmö, 205 02

  • Prostatacancercentrum

    Stockholm, 112 19

  • Sodersjukhuset

    Stockholm, 11883

Other trials in Sweden

Jordan1 site

  • King Hussein Cancer Center

    Amman, 0000

Other trials in Jordan

About this study

Official title: A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET With an Observational Cohort

The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.

Being tested
Radiotherapy, LHRHa, Apalutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • RadiotherapyRadiation

    Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.

  • LHRHaDrug

    Participants will be administered with LHRHa (example, leuprolide, goserelin, triptorelin acetate) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12 or as a 6-monthly depot preparation within 3 days after randomization.

  • ApalutamideDrug

    Also called JNJ-56021927

    Participants will receive therapeutic dose of apalutamide 240 mg once daily for 180 Days.

Study groups in NCT04557059
Study groupRoleWhat they receive
Interventional Cohort (Group 1): RT+ LHRHaActive comparatorParticipants will receive radiotherapy (RT) which is defined as prostate-bed plus pelvic lymph node salvage external-beam radiotherapy with or without optional stereotactic body radiation therapy (SBRT), along with a luteinizing hormone-releasing hormone agonist (LHRHa) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomization.
Receives: Radiation: Radiotherapy; Drug: LHRHa
Interventional Cohort (Group 2): RT+LHRHa + ApalutamideExperimentalParticipants will receive prostate-bed plus pelvic lymph node salvage external-beam radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), along with a LHRHa as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomization. Participants will also receive 240 milligram (mg) of apalutamide starting within 3 days after randomization as film-coated tablets, to be swallowed whole and together once daily with or without food, for a period of 180 Days.
Receives: Radiation: Radiotherapy; Drug: LHRHa; Drug: Apalutamide
Observational Cohort(Group3) PSMA-PET Negative ParticipantsNo interventionEnrollment into this cohort will be stopped further. Participants who were PSMA-PET-negative at screening and were already enrolled in the Observational Cohort will continue in this cohort. Data collected in the course of routine clinical practice during this period will include clinical evaluations, disease progression, therapies administered as per standard-of-care at the study-sites and survival status. For Observational Cohort, information will be entered into the electronic case report form (eCRF) from the medical records at least twice a year. The use of any medicinal product(s) for the treatment and management of participants will be at discretion of the treating physician.

What is being measured

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

  1. Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS)

    ppMPFS is defined as the appearance of at least one new PSMA-PET-positive distant lesion compared with the previous scan as assessed by blinded independent central review (BICR) or death.

    Measured: Up to 9 years

Secondary outcomes (7)

  1. Time to Prostate-Specific Antigen (PSA) Progression

    Time to PSA progression is defined as the time from randomization to the date of first documentation of PSA progression. PSA progression is defined as a PSA concentration above the nadir of more than 0.5 nanogram per milliliter (ng/mL), confirmed by additional measurement at least 3 Weeks later.

    Measured: Up to 9 years

  2. PSA Response Rate

    PSA response rate is defined as the percentage of participants with a PSA decrease of >= 50 percent (%), >= 90% or undetectable from baseline.

    Measured: Up to 9 years

  3. PSA Levels at Week 26

    PSA levels at week 26 will be reported.

    Measured: Week 26

  4. Time to Loco-Regional Progression by PSMA-PET

    Time to loco-regional progression by PSMA-PET as assessed by blinded independent central review (BCIR) is defined as the time from randomization to the date of the first occurrence of PSMA-PET loco-regional progression. Criteria for PSMA-PET loco-regional progression: Appearance of at least one new PSMA-PET-positive loco-regional lesion compared with the previous scan.

    Measured: Up to 9 years

  5. Overall Survival

    Overall survival is defined as the time from randomization to date of death from any cause.

    Measured: Up to 9 years

  6. Prostate Cancer-Specific Survival

    Prostate cancer-specific survival is defined as the time from randomization to date of death due to prostate cancer.

    Measured: Up to 9 years

  7. Number of Participants With Adverse Event (AE) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.

    Measured: Up to 9 years

Timeline

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

  1. First posted21 Sep 2020
  2. Study start12 Nov 2020
  3. Primary completion27 Aug 2029 (estimated)
  4. Study completion15 Sep 2031 (estimated)

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
691 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04557059
Sponsor's protocol ID
CR108705
Other IDs
56021927PCR3015, 2019-002957-46, 2023-505852-23-00, 2023, 2019
Acronym
PRIMORDIUM
Status last verified
Nov 2026
First submitted
17 Sep 2020
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiotherapy, LHRHa and Apalutamide in people with Prostatic Neoplasms, run by Janssen Pharmaceutica N.V., Belgium at 141 sites in 21 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in United States, Turkey (Türkiye), Brazil, Spain, Poland and 16 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?

This study is still under way. Results are not available in the source record yet.

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?

Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS) (time frame: Up to 9 years). 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 NCT04557059.

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 3 Nov 2026.

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