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JOURNAL ONKOLOGIE – STUDIE

Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH

Rekrutierend

NCT-Nummer:
NCT04597125

Studienbeginn:
November 2020

Letztes Update:
28.03.2024

Wirkstoff:
Radium-223 dichloride (Xofigo, BAY88-8223), NAH therapy

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 4

Sponsor:
Bayer

Collaborator:
-

Kontakt

Bayer Clinical Trials Contact
Kontakt:
Phone: (+)1-888-84 22937
E-Mail: clinical-trials-contact@bayer.com» Kontaktdaten anzeigen

Studienlocations
(3 von 157)

Universitätsklinikum Münster (UKM)
48149 Münster
(Nordrhein-Westfalen)
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Universitätsmedizin der Johannes Gutenberg Universität Mainz
55131 Mainz
(Rheinland-Pfalz)
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Universitätsklinikum Carl Gustav Carus Dresden
01307 Dresden
(Sachsen)
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Urologische Gemeinschaftspraxis Bremen
28277 Bremen
(Bremen)
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Universitätsmedizin Göttingen - Hämatologie und medizin. Onkologie
D-37077 Göttingen
(Niedersachsen)
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Specialist Services Medical Group
2154 Castle Hill
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North West Cancer Centre
2340 North Tamworth
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Prince of Wales Hospital NSW
2031 Randwick
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Northern Cancer Institute
2065 St Leonards
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Illawarra Shoalhaven Local Health District
2500 Wollongong
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Illawarra Shoalhaven Local Health District
2521 Wollongong
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Calvary North Adelaide Hospital
5006 North Adelaide
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Kepler Universitätsklinikum Campus III
4020 Linz
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Klinik Ottakring - Wilhelminenspital
1160 Wien
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Fakultni Nemocnice Olomouc
77900 Olomouc
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140 59 Prague
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12808 Praha 2
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180 81 Praha 8
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Kuopion yliopistollinen sairaala
70210 Kuopio
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FIN 60220 Seinäjoki
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33520 Tampere
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33000 Bordeaux
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Institut Bergonié - Unicancer Nouvelle Aquitaine
33076 Bordeaux
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14076 Caen Cedex 5
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Centre Georges Francois Leclerc Dijon
21079 Dijon
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Centre Hospitalier Universitaire - Grenoble
38700 Grenoble
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Clinique Sainte Marguerite - Hyères
83400 Hyeres
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59020 Lille Cedex
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13273 Marseille
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34298 Montpellier Cedex
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06102 Nice Cedex 2
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Institut de Cancérologie Jean Godinot
51726 Reims
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35042 Rennes
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CHU STRASBOURG - Hôpital de Hautepierre
67098 Strasbourg
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31059 Toulouse Cedex 9
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Institut de Cancérologie de Lorraine - Alexis Vautrin
54519 Vandoeuvre-les-Nancy
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Institut Gustave Roussy - Département de Médecine Oncologique
94805 Villejuif Cedex
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Central
Hong KongNoch nicht rekrutierend» Google-Maps
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Chai Wan
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Hong Kong
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Magyar Honvedseg Egeszsegugyi Kozpont
1062 Budapest
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4032 Debrecen
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Tolna Varmegyei Balassa Janos Korhaz
7100 Szekszard
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Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
H-5004 Szolnok
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3436212 Haifa
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5822012 Holon
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9112001 Jerusalem
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4941492 Petah Tikva
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6423906 Tel Aviv
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A.O.R.N. Antonio Cardarelli
80131 Napoli
ItalyNoch nicht rekrutierend» Google-Maps
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42123 Reggio Emilia
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33081 Pordenone
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
00168 Roma
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IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)
20141 Milano
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A.O. Nazionale SS Antonio e Biagio e Cesare Arrigo - Oncologia
15121 Alessandria
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Istituto Oncologico Veneto IRCCS (IOV)
35128 Padova
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National Cancer Center
10408 Goyang-si
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463-707 Seongnam-si
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3080 Seoul
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06591 Seoul
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138-736 Seoul
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LT-50009 Kaunas
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LT-92288 Klaipeda
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LT-08660 Vilnius
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Vilnius University Hospital Santaros Klinikos
LT-08661 Vilnius
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Centrum Onkologii im. Prof. Franciszka Lukaszczyka
85-796 Bydgoszcz
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Swietokrzyskie Centrum Onkologii
25-734 Kielce
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75-851 Koszalin
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Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
31-115 Krakow
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Szpital Grochowski im. dr.med. Rafala Masztaka
04-073 Warszawa
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Uniwersytecki Szpital Kliniczny UM we Wroclawiu
50-556 Wroclaw
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Chelyabinsk Regional Oncology Dispensary
454087 Chelyabinsk
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Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS
115552 Moscow
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National Medical Research Radiology Center
249036 Obninsk
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Clinical Oncological Dispensary of Omsk Region
644013 Omsk
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Samara Regional Clinical Oncology Dispensary
443031 Samara
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Tomsk National Research Medical Center of RAS
634009 Tomsk
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Singapore General Hospital
169608 Singapore
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National Cancer Center Singapore
169610 Singapore
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15706 Santiago de Compostela
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11009 Cadiz
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08916 Badalona (Barcelona)
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07120 Palma de Mallorca
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28222 Majadahonda
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15009 A Coruña
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Hospital de la Santa Creu i Sant Pau | Gynecology Department
08025 Barcelona
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Ciutat Sanitaria i Universitaria de la Vall d'Hebron
08035 Barcelona
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Consorcio Hospitalario Provincial de Castellón
12002 Castellón
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28034 Madrid
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28041 Madrid
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29010 Málaga
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Instituto Valenciano de Oncología
46009 Valencia
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Kaohsiung Medical University Chung-Ho Memorial Hospital
807377 Kaohsiung City
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Taichung Veterans General Hospital
40705 Taichung
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National Cheng Kung University Hospital
704 Tainan
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Taipei Veterans General Hospital
11217 Taipei
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Chang Gung Memorial Hospital at Linkou
33305 Taoyuan
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Baskent Universitesi Seyhan Hastanesi
1250 Adana
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Hacettepe Universitesi Tip Fakultesi
06100 Ankara
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Ankara Yildirim Beyazit Universitesi Tip Fakültesi
6050 Ankara
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Ankara Universitesi Tip Fakultesi Hastanesi
Ankara
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Gaziantep Universitesi Tip Fakultesi
27010 Gaziantep
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Koc Universitesi Tip Fakultesi - Radyoloji
34010 Istanbul
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34093 Istanbul
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Istanbul Egitim ve Arastirma Hastanesi
34098 Istanbul
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Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
34098 Istanbul
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TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has
34772 Istanbul
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Medipol Universitesi Tip Fakultesi
34810 Istanbul
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Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi
34899 Istanbul
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Izmir Tepecik Egitim ve Arastirma Hastanesi
35020 Izmir
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35330 Izmir
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35575 Karsiyaka
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38039 Kayseri
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33070 Mersin
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55139 Samsun
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RG1 5AN Reading
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PR2 4HT Preston
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GU2 7XX Guildford
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G12 0YN Glasgow
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Royal Free Hospital
NW3 2QG London
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Alle anzeigen

Studien-Informationen

Brief Summary:

Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and

new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which

has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile

researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223

dichloride is known as a radioactive drug that is taken up by bones after it is injected into

the body. It works by giving off a type of radioactivity that travels a very short distance

and kills the tumor cells that have spread to the bone without major effects to the healthy

cells. It has been approved in many countries for the treatment of patients with prostate

cancer which has spread to the bone. The NAH drugs used in this study will be either

abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of

them are standard approved medications which are used in the treatment of advanced prostate

cancer.

Participants in this study will receive either Radium-223 dichloride or a NAH therapy.

Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each

4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard

approved dose once daily until the disease has progressed. Participants will visit the

hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each

cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years

in total. Blood and urine samples will be collected from the participants and participants

will be asked to complete questionnaires about the well-being and the pain.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participants who have histologically confirmed adenocarcinoma of the prostate.

- Participants with mCRPC progressing on/after one line of an approved NAH (eg.

abiraterone, enzalutamide, apalutamide, or darolutamide, after being treated for at

least 3 months) in an authorized prostate cancer indication.

- One prior taxane treatment regimen (at least 2 cycles) for metastatic prostate cancer

(mHSPC and mCRPC) or refusal or ineligibility of such a regimen.

- Prostate cancer progression documented by PSA according to the Prostate Cancer Working

Group 3 (PCWG3) criteria or radiological progression according to RECIST, version 1.1.

- At least 2 bone metastases on bone scan within 4 weeks prior to randomization with no

current or history of lung, liver, other visceral, and / or brain metastasis.

- Symptomatic prostate cancer. A worst pain score (WPS) of at least 1 on the Brief Pain

Inventory-Short Form (BPI-SF) Question #3 (worst pain in last 24 hours). This is to be

assessed once during the Screening period.

- Maintenance of medical castration or surgical castration with testosterone less than

50 ng/dL (1.7 nmol/L). If the participant is being treated with luteinizing hormone

releasing hormone (LHRH) agonists or antagonists (participant who has not undergone

orchiectomy), this therapy must have been initiated at least 4 weeks prior to

randomization and must be continued throughout the study.

- Participants must be on a BHA treatment, such as bisphosphonates or denosumab

treatment unless such treatment is contraindicated or not recommended per

investigator's judgement and inclusion is agreed to by the medical monitor.

- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.

- Life expectancy ≥ 6 months.

- Able to swallow abiraterone and prednisone/prednisolone or enzalutamide as whole

tablets/capsules.

- Laboratory requirements:

- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L

- Platelet count ≥ 100 x 10^9/L

- Hemoglobin (Hb) ≥ 9.0 g/dL (90 g/L; 5.6 mmol/L)

- Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (except

for participants with documented Gilbert's disease)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN

- Creatinine ≤ 1.5 x ULN or estimated glomerular filtration rate (eGFR) ≥ 30

mL/min/1.73 m^2 as calculated using the Cockcroft-Gault equation

- International normalized ratio (INR) of prothrombin time (PT; PT-INR) and partial

thromboplastin time (PTT) ≤ 1.5 times the ULN. Participants treated with warfarin

or heparin will be allowed to participate in the study if no underlying

abnormality in coagulation parameters exists per prior history; weekly evaluation

of PT-INR / PTT will be required until stability is achieved (as defined by local

standard of care and based on pre-study PT-INR / PTT values)

- Serum albumin > 30 g/L

- Serum potassium ≥ 3.5 mmol/L

- Capable of giving signed informed consent

Exclusion Criteria:

- Active infection or other medical condition that would make prednisone / prednisolone

(corticosteroid) use contraindicated.

- Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg

prednisone / prednisolone equivalent daily for more than 2 months.

- Pathological finding consistent with tumors with predominant neuroendocrine features

or small cell carcinoma of the prostate.

- History of osteoporotic fracture

- History of visceral metastasis, or presence of visceral metastasis detected by

screening imaging examinations.

- History of or known brain metastasis.

- Malignant lymphadenopathy exceeding 3 cm in short-axis diameter.

- Other malignancy treated within the last 3 years (except non-melanoma skin cancer or

low-grade superficial bladder cancer)

- Imminent spinal cord compression based on clinical findings and / or magnetic

resonance imaging (MRI). Participants with history of spinal cord compression should

have completely recovered.

- Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood

pressure ≥ 95 mmHg). Participants with a history of hypertension are allowed provided

blood pressure is controlled by anti-hypertensive treatment.

- Active or symptomatic viral hepatitis

- History of pituitary or adrenal dysfunction

- Any other serious illness or medical condition such as, but not limited to:

- Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse

Events (NCI-CTCAE) version 5.0 Grade 2

- Clinically significant heart disease as evidenced by myocardial infarction, or

arterial thrombotic events in the past 6 months, severe or unstable angina, or

New York Heart Association (NYHA) Class II to IV heart disease or cardiac

ejection fraction measurement of <50% at baseline

- Current clinical evidence of any uncontrolled cardiac arrhythmia

- Crohn's disease or ulcerative colitis

- Bone marrow dysplasia

- Moderate and severe hepatic impairment (Child-Pugh Classes B and C)

- Unmanageable fecal incontinence.

- Any condition, which in the opinion of the investigator would preclude participation

in this trial (eg, history of seizure).

- Hypersensitivity to the active substances or to any excipients of radium-223

dichloride, or abiraterone acetate or enzalutamide.

- Prior therapeutic systemic radiation with any radiopharmaceutical medication for the

treatment of prostate cancer, including but not limited to lutetium-177, strontium-89,

samarium-153, iodine-131, rhenium-186, rhenium-188, or radium-223. Radiopharmaceutical

compounds used for diagnosis purposes only are allowed.

- Prior hemibody external radiotherapy is excluded. Participants who received other

types of prior external radiotherapy are allowed provided that the bone marrow

function is assessed and meets the protocol requirements for Hb, ANC, and platelet

count.

- Blood transfusion or erythropoietin stimulating agents 4 weeks prior to Screening and

during the whole Screening period before randomization.

- Excessive intake of biotin above the recommended daily dose of 30 μg. Biotin is found

in multivitamins, including prenatal multivitamins, biotin supplements, and dietary

supplements for hair, skin, and nail growth at levels that may interfere with

laboratory tests.

- Prior administration of an investigational therapeutic for CRPC.

- Previous (within the last 4 weeks of randomization) or concurrent participation in any

interventional clinical study with investigational study drug administration.

Studien-Rationale

Primary outcome:

1. Overall survival (OS) (Time Frame - Up to five years)



Secondary outcome:

1. Time to first symptomatic skeletal event (SSE) (Time Frame - Up to five years)

2. Radiological Progression-free survival (rPFS) (Time Frame - Up to five years):
rPFS is defined as the time from the date of randomization to the date of confirmed radiological progression or death, whichever occurs first.

3. Time to pain progression (BPI-SF) (Time Frame - Up to five years):
The Brief Pain Inventory-Short Form (BPI-SF) is a self-administered questionnaire with 11 items designed to evaluate the intensity of, and the impairment caused by pain. Four items measure pain intensity using 0 ("no pain") to 10 ("pain as bad as you can imagine") numeric rating scales, and 7 items measure the level of interference with function caused by pain using 0 (no interference) to 10 (complete interference) rating scales.

4. Adverse events assessments using NCI CTCAE (v5.0) (Time Frame - After first administration of study intervention up to 30 days after the last dose of study intervention)

5. Incidence of fractures (Time Frame - Up to five years)

6. Time to deterioration of FACT-P total score (Time Frame - Up to five years):
The FACT-P questionnaire assesses prostate cancer-related quality of life. The FACT-P total score is the sum of the scores of 39 items of the questionnaire and ranges from 1 to 156, the higher the score, the better the quality of life of prostate cancer patients.

Studien-Arme

  • Experimental: Arm A
    Participants with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of NAH will be randomized to receive radium-223 dichloride
  • Active Comparator: Arm B
    Participants with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of NAH will be randomized to receive second novel anti-hormonal therapy (NAH)

Geprüfte Regime

  • Radium-223 dichloride (Xofigo, BAY88-8223):
    Participants will receive Radium-223 (BAY88-8223) every 4 weeks for a total of 6 administrations via intravenous (IV) injection
  • NAH therapy (Second novel anti-hormonal therapy):
    Participants will receive continuous NAH (either Abiraterone acetate plus prednisone/prednisolone [AAP] or enzalutamide) by mouth (per os) daily

Quelle: ClinicalTrials.gov


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"Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH"

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