Prostate Cancer Clinical Trial
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
Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer.
BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker for prostate cancer development. This may mean that the cancer has come back even though no cancer or cancer spreading is yet detectable using conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans. Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly men with a stage of prostate cancer where the PSA levels raised to a certain limit within a specified period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat.
In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells. Next generation androgen receptor inhibitors (ARIs) including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments.
The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo and ADT given for 24 months. A placebo is a treatment that looks like a medicine but does not have any medicine in it.
To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer" that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells.
To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration will be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy.
During the study, the study team will:
take blood and urine samples.
measure PSA and testosterone levels in the blood samples
do physical examinations
check the participants' overall health
examine heart health using electrocardiogram (ECG)
check vital signs
check cancer status using PSMA PET/CT scans, CT, MRI and bone scans
take tumor samples (if required)
ask the participants if they have medical problems
About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first.
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 (or refused) for 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 or central values accepted).
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.
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.
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There are 202 Locations for this study
Phoenix Arizona, 85054, United States
Tucson Arizona, 85704, United States
Duarte California, 91010, United States
Los Angeles California, 90033, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
San Francisco California, 94143, United States
Lakewood Colorado, 80228, United States
Clermont Florida, 34711, United States
Jacksonville Florida, 32209, United States
Orange City Florida, 32763, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Greenwood Indiana, 46143, United States
Jeffersonville Indiana, 47130, United States
Kansas City Kansas, 66160, United States
Baltimore Maryland, 21204, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02115, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48201, United States
Troy Michigan, 48084, United States
Minneapolis Minnesota, 55455, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68130, United States
Saddle Brook New Jersey, 07663, United States
Voorhees New Jersey, 08043, United States
New York New York, 10016, United States
Syracuse New York, 13210, United States
White Plains New York, 10601, United States
Greensboro North Carolina, 27403, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45212, United States
Columbus Ohio, 43210, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Lancaster Pennsylvania, 17604, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15232, United States
Pittsburgh Pennsylvania, 15240, United States
Greenville South Carolina, 29607, United States
Myrtle Beach South Carolina, 29579, United States
Austin Texas, 78759, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78257, United States
Spokane Washington, 99202, United States
Camperdown New South Wales, 2050, Australia
Liverpool New South Wales, 2170, Australia
Macquarie University New South Wales, 2109, Australia
Newcastle New South Wales, 2290, Australia
Port Macquarie New South Wales, 2444, Australia
Sydney New South Wales, 2010, Australia
Wahroonga New South Wales, 2076, Australia
Westmead New South Wales, 2145, Australia
Bundaberg Queensland, 4670, Australia
Pialba Queensland, 4655, Australia
Southport Queensland, 4215, Australia
Box Hill Victoria, 3128, Australia
East Melbourne Victoria, 3002, Australia
Malvern Victoria, 3144, Australia
Melbourne Victoria, 3052, Australia
Heidelberg , , Australia
Randwick , 2031, Australia
Linz Oberösterreich, 4020, Austria
Innsbruck , 6020, Austria
Salzburg , 5020, Austria
Wien , 1020, Austria
Wien , 1090, Austria
Salvador Bahia, 41950, Brazil
Curitiba Parana, 81520, Brazil
Natal Rio Grande Do Norte, 59062, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Santo André Sao Paulo, 09060, Brazil
São Paulo Sao Paulo, 01246, Brazil
São Paulo Sao Paulo, 04039, Brazil
São Paulo Sao Paulo, 05651, Brazil
Sao Paulo , 01308, Brazil
Calgary Alberta, T2V 1, Canada
Vancouver British Columbia, V6H 3, Canada
Victoria British Columbia, V8R 6, Canada
Halifax Nova Scotia, B3H 2, Canada
Hamilton Ontario, L8V 5, Canada
London Ontario, N6A 4, Canada
Toronto Ontario, M5G 2, Canada
Levis Quebec, G6V 3, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H3T 1, Canada
Abbotsford , V2S 0, Canada
Sherbrooke , J1H 5, Canada
Wuhan Hubei, 43003, China
Hohehot Inner Mongolia, 01005, China
Nanjing Jiangsu, 21000, China
Shanghai Jiangsu, 20003, China
Chengdu Sichuan, 61004, China
Hangzhou Zhejiang, 31000, China
Beijing , 10073, China
Shanghai , 20002, China
Tianjin , 30030, China
Aalborg , 9000, Denmark
Aarhus N , 8200, Denmark
Copenhagen , 2100, Denmark
Helsinki , 00180, Finland
Helsinki , 00290, Finland
Oulu , 90220, Finland
Tampere , 33520, Finland
Turku , FIN-2, Finland
Bordeaux , 33000, France
Clermont-ferrand , 63011, France
Grenoble , 38048, France
Lille , 59037, France
PARIS cedex 5 , 75248, France
Paris , 75018, France
Pierre Benite , 69495, France
Reims , 51726, France
Rennes Cedex , 35033, France
Saint-cloud , 92210, France
Saint-Herblain , 44800, France
Strasbourg , 67033, France
Tours , 37044, France
Villejuif Cedex , 94805, France
Mannheim Baden-Württemberg, 68167, Germany
Nürtingen Baden-Württemberg, 72622, Germany
München Bayern, 81675, Germany
Würzburg Bayern, 97080, Germany
Frankfurt Hessen, 60596, Germany
Braunschweig Niedersachsen, 38126, Germany
Göttingen Niedersachsen, 37075, Germany
Köln Nordrhein-Westfalen, 50937, Germany
Münster Nordrhein-Westfalen, 48149, Germany
Magdeburg Sachsen-Anhalt, 39120, Germany
Dresden Sachsen, 01307, Germany
Bergisch Gladbach , 51465, Germany
Berlin , 10967, Germany
Berlin , 12203, Germany
Jena , 07747, Germany
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Jerusalem , 93722, Israel
Petah Tikva , 49414, Israel
Tel Hashomer , 52621, Israel
Tel-Aviv , 64239, Israel
Napoli Campania, 80131, Italy
Bologna Emilia-Romagna, 40138, Italy
Bologna Emilia-Romagna, 40139, Italy
Modena Emilia-Romagna, 41124, Italy
Reggio Emilia Emilia-Romagna, 42123, Italy
Pordenone Friuli-Venezia Giulia, 33081, Italy
Roma Lazio, 00133, Italy
Roma Lazio, 00144, Italy
Roma Lazio, 00168, Italy
Bergamo Lombardia, 24127, Italy
Milano Lombardia, 20089, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20133, Italy
Torino Piemonte, 10126, Italy
Bari Puglia, 70124, Italy
Foggia Puglia, 71100, Italy
Padova Veneto, 35128, Italy
Verona Veneto, 37024, Italy
Verona Veneto, 37126, Italy
Genova , 16132, Italy
Perugia , 06123, Italy
Trento , 38122, Italy
Sapporo Hokkaido, 060-8, Japan
Kanazawa Ishikawa, 920-8, Japan
Yokohama Kanagawa, 236-0, Japan
Suita Osaka, 565-0, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Kagoshima , 890-8, Japan
Kyoto , 606-8, Japan
Auckland , , New Zealand
Christchurch , 8013, New Zealand
Tauranga , 3112, New Zealand
Braga , 4710-, Portugal
Lisboa , 1099-, Portugal
Lisboa , 1350-, Portugal
Lisboa , 1400-, Portugal
Lisboa , 1500-, Portugal
Lisboa , 1649-, Portugal
Santiago de Compostela A Coruña, 15706, Spain
Barcelona , 08003, Spain
Barcelona , 08023, Spain
Barcelona , 08025, Spain
Barcelona , 08035, Spain
Cadiz , 11009, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28050, Spain
Murcia , 30008, Spain
Málaga , 29010, Spain
Sevilla , 41013, Spain
Valencia , 46009, Spain
Valencia , 46026, Spain
Gothenburg , 413 4, Sweden
Malmo , 20502, Sweden
Uppsala , 751 8, Sweden
Bedford Bedfordshire, MK42 , United Kingdom
Northwood Middlesex, HA6 2, United Kingdom
Guildford Surrey, GU2 7, United Kingdom
London , NW1 2, United Kingdom
London , SW3 6, United Kingdom
London , W6 8R, United Kingdom
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