A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies
Launched by BAYER · Mar 21, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment approach for men who have hormone-sensitive prostate cancer that has returned after initial treatment, indicated by rising levels of a protein called PSA. Researchers want to find out if adding a medication called darolutamide to standard hormone therapy (called androgen deprivation therapy or ADT) can help men live longer without their cancer worsening compared to those who receive a placebo (a pill without active medication) along with ADT. This study is important because rising PSA levels can signal that cancer may be coming back, and early treatment could prevent it from spreading further.
To be eligible for this study, participants need to be men aged 18 or older who have been diagnosed with prostate cancer and have experienced a biochemical recurrence. They should have received prior treatment such as surgery or radiation but are now showing signs of cancer returning. Participants will take the assigned treatment for 24 months and will be closely monitored through regular health check-ups, blood tests, and scans to track their PSA levels and overall health. This study will help researchers learn more about the effectiveness of combining darolutamide with ADT, potentially leading to better treatment options for men facing this challenging situation.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • Capable of giving signed informed consent as described which includes compliance with the requirements, restrictions listed in the informed consent form (ICF), and in this protocol.
- • Male ≥18 years of age at the time of signing the informed consent.
- • Histologically or cytologically confirmed adenocarcinoma of prostate.
- • Prostate cancer initially treated by: radical prostatectomy (RP) followed by adjuvant radiotherapy (ART), or salvage radiotherapy (SRT), or RP in participants who are unfit for (or refused) ART or SRT, or primary radiotherapy (RT).
- • High-risk biochemical recurrence (BCR), defined as Prostate-specific antigen doubling time (PSADT) \<12 months calculated using the formula provided by the Sponsor, and PSA ≥0.2 ng/mL after ART or SRT post RP or after RP in participants who are unfit for ART or SRT (local or central values accepted), or PSA ≥2 ng/mL above the nadir after primary RT only (local or central values accepted).
- • Participants must undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 42-day Screening period using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11 which will be assessed by blinded independent central review (BICR) to identify at least one PSMA PET/CT lesion of prostate cancer.
- • Serum testosterone ≥150 ng/dL (5.2 nmol/L) (local assessment is allowed whenever central assessment cannot be done).
- • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- • Blood counts at screening: Hemoglobin ≥9.0 g/dL (participant must not have received blood transfusion within 7 days prior to sample being taken); Absolute neutrophil count (ANC) ≥1.5x10\^9/L (participant must not have received any growth factor within 4 weeks prior to sample being taken); Platelet count ≥100x10\^9/L.
- • Screening values of: Alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) ≤1.5 x ULN; Total bilirubin (TBL) ≤1.5 ULN, (except participants with a diagnosis of Gilbert's disease); Estimated glomerular filtration rate (eGFR) \>40 ml/min/1.73 m\^2 calculated by the CKD-EPI formula.
- • Sexually active male participants must agree to use contraception as detailed in the protocol during the Treatment period and for at least 1 week after the last dose of study treatment, and refrain from donating sperm during this period.
- Exclusion Criteria:
- • Pathological finding consistent with small cell, ductal or ≥50 % component of neuroendocrine carcinoma of the prostate.
- • History of bilateral orchiectomy.
- • Metastases or recurrent /new malignant lesions in prostate gland/bed seminal vesicles, lymph nodes below the CIA bifurcation on conventional imaging (CI) as assessed by BICR during screening.
- • Brain metastasis on PSMA PET /CT by BICR at screening.
- • High-risk BCR after primary radiotherapy with new loco-regional lesions on screening PSMA PET/CT who are eligible for curative salvage prostatectomy.
- • Note: Participants treated with curative salvage prostatectomy after primary RT who meet the PSA criteria (inclusion criteria 5) may be considered for the study.
- • Prior treatment with second generation (e.g. enzalutamide, apalutamide) androgen receptor inhibitors (ARIs) and CYP 17 inhibitors (e.g., abiraterone) within 18 months prior to signing of the ICF.
- • Prior treatments with PSMA-radiotherapeutics within 12 months prior to randomization.
- • Prior radiotherapy (including image-guided radiotherapy) as primary, adjuvant or salvage treatment completed within 8 weeks prior to signing of the ICF.
- • Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years.
- • History of pelvic radiotherapy for other malignancy.
About Bayer
Bayer is a global healthcare and life sciences company dedicated to advancing health and well-being through innovative research and development. With a strong commitment to improving patient outcomes, Bayer conducts clinical trials across various therapeutic areas, including oncology, cardiology, and women's health. The company leverages cutting-edge science and technology to develop breakthrough therapies, while adhering to the highest standards of ethical practices and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Bayer aims to bring transformative solutions to the market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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Saint Louis, Missouri, United States
Copenhagen, , Denmark
Adelaide, South Australia, Australia
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Westmead, New South Wales, Australia
London, Ontario, Canada
Liverpool, New South Wales, Australia
Clermont Ferrand, , France
Parkville, Victoria, Australia
Rotterdam, , Netherlands
Barcelona, , Spain
Montreal, Quebec, Canada
Duarte, California, United States
Pierre Benite, , France
Pittsburgh, Pennsylvania, United States
Boston, Massachusetts, United States
Pittsburgh, Pennsylvania, United States
Sapporo, Hokkaido, Japan
Tel Hashomer, , Israel
Chicago, Illinois, United States
Cincinnati, Ohio, United States
Nedlands, Western Australia, Australia
Houston, Texas, United States
Jacksonville, Florida, United States
Port Macquarie, New South Wales, Australia
Camperdown, New South Wales, Australia
Kyoto, , Japan
Taipei, , Taiwan
Phoenix, Arizona, United States
Boston, Massachusetts, United States
Baltimore, Maryland, United States
Kansas City, Kansas, United States
Minneapolis, Minnesota, United States
Lancaster, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Berlin, , Germany
Montreal, Quebec, Canada
San Antonio, Texas, United States
Eindhoven, , Netherlands
Madrid, , Spain
Heidelberg, Victoria, Australia
Geelong, Victoria, Australia
Chicago, Illinois, United States
Greenwood, Indiana, United States
Valencia, , Spain
London, , United Kingdom
Groningen, , Netherlands
Madrid, , Spain
Tel Aviv, , Israel
Melbourne, Victoria, Australia
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Blacktown, New South Wales, Australia
Suita, Osaka, Japan
Würzburg, Bayern, Germany
Beijing, Beijing, China
Aalborg, , Denmark
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Malvern, Victoria, Australia
Tours, , France
Troy, Michigan, United States
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Lisboa, , Portugal
Cadiz, , Spain
Innsbruck, , Austria
Epping, Victoria, Australia
Guildford, Surrey, United Kingdom
Greensboro, North Carolina, United States
Beijing, , China
Winston Salem, North Carolina, United States
Budapest, , Hungary
Nieuwegein, , Netherlands
Richmond, Victoria, Australia
München, Bayern, Germany
Köln, Nordrhein Westfalen, Germany
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Wahroonga, New South Wales, Australia
Eindhoven, Noord Brabant, Netherlands
Santander, Cantabria, Spain
Camperdown, New South Wales, Australia
Nanjing, Jiangsu, China
Madrid, , Spain
Brisbane, Queensland, Australia
London, , United Kingdom
Madrid, , Spain
Changsha, Hunan, China
Vancouver, British Columbia, Canada
Wroclaw, , Poland
Tampere, , Finland
Phoenix, Arizona, United States
Columbus, Ohio, United States
Aarhus N, , Denmark
Tours, , France
London, , United Kingdom
Valencia, , Spain
München, Bavaria, Germany
Málaga, , Spain
Roma, , Italy
Valencia, , Spain
Jeffersonville, Indiana, United States
Geelong, , Australia
Milano, Lombardia, Italy
New York, New York, United States
Syracuse, New York, United States
Bala Cynwyd, Pennsylvania, United States
White Plains, New York, United States
Heidelberg, , Australia
Omaha, Nebraska, United States
Turku, , Finland
Santiago De Compostela, A Coruña, Spain
Barcelona, , Spain
Chengdu, Sichuan, China
Salvador, Bahia, Brazil
Yokohama, Kanagawa, Japan
Tucson, Arizona, United States
Halifax, Nova Scotia, Canada
Santo André, Sao Paulo, Brazil
Oulu, , Finland
Sydney, New South Wales, Australia
São Paulo, Sao Paulo, Brazil
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Bologna, Emilia Romagna, Italy
Calgary, Alberta, Canada
Roma, Lazio, Italy
Nürtingen, , Germany
Dresden, Sachsen, Germany
Roma, Lazio, Italy
Innsbruck, Tirol, Austria
Bordeaux, , France
Montpellier, , France
Sao Paulo, , Brazil
Frankfurt, Hessen, Germany
Milano, Lombardia, Italy
Trento, , Italy
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São Paulo, Sao Paulo, Brazil
Strasbourg, , France
Roma, Lazio, Italy
Milano, Lombardia, Italy
Padova, Veneto, Italy
Lisboa, , Portugal
Porto, , Portugal
Kagoshima, , Japan
London, , United Kingdom
Haifa, , Israel
Hangzhou, Zhejiang, China
Helsinki, , Finland
Herne, Nordrhein Westfalen, Germany
Münster, Nordrhein Westfalen, Germany
Jerusalem, , Israel
Braga, , Portugal
Paris Cedex 5, , France
Dresden, Sachsen, Germany
Dijon, , France
Marseille, , France
East Melbourne, Victoria, Australia
Bergamo, Lombardia, Italy
Linz, , Austria
Orange, California, United States
Christchurch, , New Zealand
Toronto, Ontario, Canada
Rennes Cedex, , France
Modena, Emilia Romagna, Italy
Verona, Veneto, Italy
London, , United Kingdom
Dijon, , France
Mannheim, Baden Württemberg, Germany
Toulouse Cedex 9, , France
Wien, , Austria
Verona, Veneto, Italy
Bydgoszcz, , Poland
Voorhees, New Jersey, United States
Greenville, South Carolina, United States
Wien, , Austria
Helsinki, , Finland
Petah Tikva, , Israel
Kielce, , Poland
Taoyuan, , Taiwan
Barcelona, , Spain
Chicago, Illinois, United States
Detroit, Michigan, United States
Linz, Oberösterreich, Austria
Salzburg, , Austria
Lisboa, , Portugal
Frankfurt, Hessen, Germany
Sao Paulo, , Brazil
Southport, Queensland, Australia
Saint Cloud, , France
Nürtingen, Baden Württemberg, Germany
Rennes Cedex, , France
Liverpool, New South Wales, Australia
San Antonio, Texas, United States
Newcastle, New South Wales, Australia
Bala Cynwyd, Pennsylvania, United States
Myrtle Beach, South Carolina, United States
Paris, , France
Box Hill, Victoria, Australia
Reggio Emilia, Emilia Romagna, Italy
Warszawa, , Poland
Berlin, , Germany
Taoyuan, , Taiwan
Krakow, , Poland
Hohehot, Inner Mongolia, China
Tampere, , Finland
Los Angeles, California, United States
Omaha, Nebraska, United States
Curitiba, Parana, Brazil
São Paulo, Sao Paulo, Brazil
Braunschweig, Niedersachsen, Germany
Napoli, Campania, Italy
Hilversum, , Netherlands
Lisboa, , Portugal
Victoria, British Columbia, Canada
Hamilton, Ontario, Canada
Tauranga, , New Zealand
Lisboa, , Portugal
Verona, Veneto, Italy
Pordenone, Friuli Venezia Giulia, Italy
Vancouver, British Columbia, Canada
Greensboro, North Carolina, United States
Lille, , France
Bologna, Emilia Romagna, Italy
Epping, , Australia
Lisboa, , Portugal
Bordeaux Cedex, , France
Olomouc, , Czechia
Villejuif, , France
Malvern, Victoria, Australia
Helsinki, , Finland
Grenoble Cedex 09, , France
Foggia, Puglia, Italy
North Melbourne, Victoria, Australia
Saint Herblain, , France
Barcelona, , Spain
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Clermont, Florida, United States
Hamilton, Ontario, Canada
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Randwick, , Australia
Salvador, Bahia, Brazil
Natal, Rio Grande Do Norte, Brazil
Victoria, British Columbia, Canada
Sherbrooke, , Canada
Beijing, , China
Turku, , Finland
Grenoble, , France
St Herblain, , France
Mannheim, Baden Württemberg, Germany
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Jerusalem, , Israel
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Bari, Puglia, Italy
Foggia, Puglia, Italy
Castelfranco Veneto, , Italy
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Perugia, , Italy
Rozzano, , Italy
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Gothenburg, , Sweden
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Nanjing, , China
Bruxelles, , Belgium
São Paulo, Sao Paulo, Brazil
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Maribyrnong, , Australia
Gent, , Belgium
Gent, , Belgium
Hasselt, , Belgium
Leuven, , Belgium
Brno, , Czechia
The Hague, , Netherlands
Taichung, , Taiwan
Taipei, , Taiwan
Sao Paulo, , Brazil
Braga, , Portugal
Lisboa, , Portugal
Madrid, , Spain
Lisboa, , Portugal
Vandoeuvre Les Nancy, , France
Marseille, , France
Austin, Texas, United States
Brno, , Czechia
Horovice, , Czechia
Praha 2, , Czechia
Hamburg, , Germany
Mainz, , Germany
Budapest, , Hungary
Gyor, , Hungary
Nyiregyhaza, , Hungary
Roma, Lazio, Italy
Lublin, , Poland
Coimbra, , Portugal
Mineola, New York, United States
Vienna, Wien, Austria
Graz, , Austria
Wien, , Austria
Bayonne, , France
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Chicago, Illinois, United States
Wuhan, Hubei, China
Helsinki, , Finland
Auckland, , New Zealand
Lisboa, , Portugal
Manchester, Surrey, United Kingdom
Wuhan, Hubei, China
Barcelona, , Spain
Hilversum, , Netherlands
Dallas, Texas, United States
Greenfield Park, Quebec, Canada
Montreal, Quebec, Canada
Edmonton, , Canada
Gatineau, , Canada
Trois Rivieres, , Canada
Hohehot, Inner Mongolia, China
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Lisboa, , Portugal
Uppsala, , Sweden
Taipei, , Taiwan
Bauru, , Brazil
Petah Tikva, , Israel
Hasselt, , Belgium
La Louvière, , Belgium
Leuven, , Belgium
Fortaleza, Ceará, Brazil
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Recife, , Brazil
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Sao Paulo, , Brazil
Quebec, , Canada
Prague, , Czechia
Jena, , Germany
Wesel, , Germany
Perugia, , Italy
Groningen, , Netherlands
Tbc, , New Zealand
Sao Paulo, , Brazil
Randwick, New South Wales, Australia
Maribyrnong, Victoria, Australia
Gent, , Belgium
Recife, Pernambuco, Brazil
Rio De Janeiro, Rj, Brazil
São Paulo, Tbc, Brazil
Rio De Janeiro, , Brazil
London, Ontario, Canada
Gatineau, Quebec, Canada
Trois Rivieres, Quebec, Canada
Quebec, , Canada
Shanghai, Jiangsu, China
Prague, , Czechia
Prague, , Czechia
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Besancon, , France
Lille, , France
Lyon, , France
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Herne, Nrw, Germany
Aachen, , Germany
Kiel, , Germany
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Roma, Lazio, Italy
Roma, Lazio, Italy
Genova, Liguria, Italy
Milano, Lombardia, Italy
Rozzano, Lombardia, Italy
Trento, Trentino, Italy
Perugia, Umbria, Italy
Castelfranco Veneto, Veneto, Italy
Roma, Veneto, Italy
Bergamo, , Italy
Dordrecht, , Netherlands
Lisbon, Lisboa, Portugal
Lisboa, , Portugal
Uppsala, , Sweden
Northwood, Middlesex, United Kingdom
Porto Alegre, Rio Grande Do Sul, Brazil
Milano, Lombardia, Italy
København ø, , Denmark
Perugia, Umbria, Italy
Bunkyo Ku, Tokyo, Japan
Goodyear, Arizona, United States
Saint Louis, Missouri, United States
New York, New York, United States
Roma, Lazio, Italy
Bergamo, Lombardia, Italy
Torino, Piemonte, Italy
Foggia, Puglia, Italy
Trento, Trentino, Italy
Roma, Veneto, Italy
Reggio Emilia, Emilia Romagna, Italy
Cuneo, , Italy
Palmerston North, , New Zealand
Helsinki, Uusimaa, Finland
Liverpool Bc, New South Wales, Australia
Sydney, New South Wales, Australia
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Edmonton, Alberta, Canada
Hohehot, Inner Mongolia, China
Grenoble, Grenoble Cedex 9, France
Brunswick, Lower Saxony, Germany
Goettingen, Lower Saxony, Germany
Hamburg, , Germany
Hilversum, , Netherlands
Christchurch, Canterbury, New Zealand
Taipei, , Taiwan
Detroit, Michigan, United States
Liverpool, New South Wales, Australia
Baltimore, Maryland, United States
Duarte, California, United States
Lakewood, Colorado, United States
Grenoble, Grenoble Cedex 9, France
Bayonne, , France
Lille, , France
Lyon, , France
Saint Herblain, , France
Strasbourg, , France
Aviano, Friuli Venezia Giulia, Italy
Brest, , France
Pierre Benite, , France
Baltimore, Maryland, United States
New York, New York, United States
São Paulo, Sao Paulo, Brazil
Abbotsford, , Canada
La Tronche, Grenoble Cedex 9, France
Clermont Ferrand, , France
Dijon, , France
Lille, , France
Reims, , France
Villejuif, , France
Modena, Emilia Romagna, Italy
Genova, Liguria, Italy
Torino, Piemonte, Italy
Suita, Osaka, Japan
Troy, Michigan, United States
Wien, , Austria
Quebec, , Canada
Besancon, , France
Bordeaux Cedex, , France
Strasbourg, , France
Göttingen, Lower Saxony, Germany
Palmerston North City, , New Zealand
Guildford, Surrey, United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Chicago, Illinois, United States
Voorhees, New Jersey, United States
Phoenix, Arizona, United States
Bordeaux, , France
Clermont Ferrand, , France
Creteil, , France
Dijon, , France
Lille, , France
Paris, , France
Toulouse, , France
Bari, Puglia, Italy
Palmerson North, , New Zealand
Praha 2, , Czechia
Santander, Cantabria, Spain
Malaga, Málaga, Spain
Barcelona, , Spain
Cadiz, , Spain
Madrid, , Spain
Madrid, , Spain
Murcia, , Spain
Sevilla, , Spain
Valencia, , Spain
Fortaleza, , Brazil
Vitória, , Brazil
La Tronche, , France
Mannheim, , Germany
Malaga, , Spain
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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