A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study)


Condition: Metastatic Castration-resistant Prostate Cancer

Intervention:

  • Drug: olaparib
  • Drug: abiraterone acetate

Purpose: The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03732820

Sponsor: AstraZeneca

Primary Outcome Measures:

  • Measure: Radiological progression free survival (rPFS)
  • Time Frame: From date of randomization to study completion (up to 4 years)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Time to first subsequent anticancer therapy or death (TFST)
  • Time Frame: From date of randomization to study completion (up to 4 years)
  • Safety Issue:
  • Measure: Time to pain progression (TTPP)
  • Time Frame: From date of randomization to study completion (up to 4 years)
  • Safety Issue:
  • Measure: Overall survival (OS)
  • Time Frame: From date of randomization to study completion (up to 4 years)
  • Safety Issue:
  • Measure: Time to opiate use
  • Time Frame: From date of randomization to study completion (up to 4 years)
  • Safety Issue:
  • Measure: Time to a Symptomatic Skeletal-Related Event (SSRE)
  • Time Frame: From date of randomization to study completion (up to 4 years)
  • Safety Issue:
  • Measure: Circulating Tumour Cells (CTC) conversion
  • Time Frame: From date of randomization to study completion (up to 4 years)
  • Safety Issue:
  • Measure: Time to second progression or death (PFS2)
  • Time Frame: From date of randomization to study completion (up to 4 years)
  • Safety Issue:
  • Measure: Brief Pain Inventory-Short Form (BPI-SF)
  • Time Frame: From date of randomization to study completion (up to 4 years)
  • Safety Issue:
  • Measure: Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P)
  • Time Frame: From date of randomization to study completion (up to 4 years)
  • Safety Issue:
  • Measure: Homologous Recombination Repair (HRR) gene status
  • Time Frame: At baseline
  • Safety Issue:
  • Measure: Maximum plasma concentration at steady state [Cmax,ss]
  • Time Frame: Week 5 from 45 min before the first olaparib dose, up to 9 hours post dose
  • Safety Issue:
  • Measure: Time to maximum plasma concentration at steady state (Cmax,ss) [tmax,ss]
  • Time Frame: Week 5 from 45 min before the first olaparib dose, up to 9 hours post dose
  • Safety Issue:
  • Measure: Minimum plasma concentration at steady state [Cmin,ss]
  • Time Frame: Week 5 from 45 min before the first olaparib dose, up to 9 hours post dose
  • Safety Issue:
  • Measure: Partial area under the concentration-time curve in 0-8 h [AUC0-8])
  • Time Frame: Week 5 from 45 min before the first olaparib dose, up to 9 hours post dose
  • Safety Issue:
  • Measure: Maximum plasma concentration at steady state [Cmax,ss]
  • Time Frame: Week 5 from 45 min before the abiraterone dose, up to 9 hours post dose
  • Safety Issue:
  • Measure: Time to maximum plasma concentration at steady state (Cmax,ss) [tmax,ss]
  • Time Frame: Week 5 from 45 min before the abiraterone dose, up to 9 hours post dose
  • Safety Issue:
  • Measure: Minimum plasma concentration at steady state [Cmin,ss]
  • Time Frame: Week 5 from 45 min before the abiraterone dose, up to 9 hours post dose
  • Safety Issue:
  • Measure: Partial area under the concentration-time curve [AUC0-8])
  • Time Frame: Week 5 from 45 min before the abiraterone dose, up to 9 hours post dose
  • Safety Issue:
  • Measure: Number of adverse events
  • Time Frame: From the time of signature of informed consent throughout the treatment period (up to 4 years plus 30 days)
  • Safety Issue:
  • Measure: Vital signs-blood pressure
  • Time Frame: From the time of signature of informed consent throughout the treatment period (up to 4 years plus 30 days)
  • Safety Issue:
  • Measure: Vital signs-pulse rate
  • Time Frame: From the time of signature of informed consent throughout the treatment period (up to 4 years)
  • Safety Issue:
  • Measure: Vital signs-body temperature
  • Time Frame: From the time of signature of informed consent throughout the treatment period (up to 4 years)
  • Safety Issue:
  • Measure: ECG
  • Time Frame: From the time of signature of informed consent throughout the treatment period (up to 4 years)
  • Safety Issue:
  • Measure: Change in Albumin (g/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Alkaline phosphatase (U/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Aspartate aminotransferase (U/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Amylase (U/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Alanine aminotransferase (U/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Total bilirubin (μmol/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Direct bilirubin
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Calcium (mmol/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Chloride (mmol/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Creatinine (μmol/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Gamma glutamyltransferase (U/L)
  • Time Frame: At screening only
  • Safety Issue:
  • Measure: Change in Fasting gucose (mmol/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Lactate dehydrogenase (U/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Magnesium (mmol/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Potassium (mmol/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Phosphorus ((mmol/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Sodium (mmol/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Carbon dioxide (mEq/L )
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Total protein (g/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Urea or blood urea nitrogen, depending on the local practice (mmol/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in absolute neutrophil count (/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in absolute lymphocyte count (/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in haemoglobin (g/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in platelet count with differential (/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in total white blood cell count with differential(/L)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in red blood cell count (/l)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Haematocrit (%)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Change in Mean Cell Volume (fL)
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Urinalysis:change in blood
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Urinalysis: Change in protein
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:
  • Measure: Urinalysis: change in glucose
  • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
  • Safety Issue:

Estimated Enrollment: 720

Study Start Date: October 31, 2018

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum 99 Years
  • Gender: Male

Inclusion Criteria:

  • 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol. 2. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses. 3. For inclusion in i) the optional exploratory genetic research and ii) the optional biomarker research, patients must fulfill the following criteria:
  • Provision of informed consent for genetic research prior to collection of sample.
  • Provision of informed consent for biomarker research prior to collection of sample. If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study. 4. Patients must be ≥18 years of age (or ≥19 years of age in South Korea) at the time of signing the informed consent form. For patients enrolled in Japan who are <20 years of age, written informed consent should be obtained from the patient and from his legally acceptable representative. 5. Histologically or cytologically confirmed prostate adenocarcinoma. 6. Metastatic status defined as at least 1 documented metastatic lesion on either a bone scan or a computed tomography(CT)/ magnetic resonance imaging (MRI) scan. 7. First-line metastatic castration-resistant prostate cancer (mCRPC). 8. Ongoing androgen deprivation with gonadotropin-releasing hormone analogue or bilateral orchiectomy, with serum testosterone <50 nanograms per decilitre (ng/dL) (<2.0 nanomoles per litre (nmol/L)) within 28 days before randomisation. Patients receiving androgen deprivation therapy (ADT) at study entry should continue to do so throughout the study. 9. Candidate for abiraterone therapy with documented evidence of progressive disease. 10. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment. 11. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, with no deterioration over the previous 2 weeks. 12. The participant has, in the opinion of the investigator, a life expectancy of at least 6 months. 13. Prior to randomisation, sites must confirm availability of either an archival formalin fixed, paraffin embedded (FFPE) tumour tissue sample, or a new biopsy taken during the screening window, which meets the minimum pathology and sample requirements in order to enable homologous recombination repair (HRR) status subgroup analysis of the primary endpoint radiographic progression-free survival (rPFS). If there is not written confirmation of the availability of tumour tissue prior to randomisation, the patient is not eligible for the study. 14. Male patients must use a condom during treatment and for 3 months after the last dose of olaparib+abiraterone when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.

Exclusion Criteria:

  1. Has a known additional malignancy that has had progression or has required active treatment in the last 5 years.
  2. Patients with myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) or with features suggestive of yelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML).
  3. Clinically significant cardiovascular disease Association Class II-IV heart failure or cardiac ejection fraction measurement of <50% during screening as assessed by echocardiography or multigated acquisition scan.
  4. Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure.
  5. Prior revascularisation procedure (significant coronary, carotid, or peripheral artery stenosis).
  6. Uncontrolled hypertension (systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or diastolic blood pressure (BP) ≥95 millimeters of mercury (mmHg)).
  7. History of uncontrolled pituitary or adrenal dysfunction.
  8. Active infection or other medical condition that would make prednisone/prednisolone use contraindicated.
  9. Any chronic medical condition requiring a systemic dose of corticosteroid >10 milligrams (mg) prednisone/prednisolone per day.
  10. Patients who are considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
  11. Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAEs] grade >2) caused by previous cancer therapy, excluding alopecia.
  12. Patients with brain metastases. A scan to confirm the absence of brain metastases is not required.
  13. Patients with spinal cord compression are excluded unless they are considered to have received definitive treatment for this and have evidence of clinically stable disease for 4 weeks.
  14. Patients who are unevaluable for both bone and soft tissue progression
  15. Patients who are unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
  16. Immunocompromised patients
  17. Patients with known active hepatitis infection (ie, hepatitis B or C).
  18. Any previous treatment with Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerase (PARP) inhibitor, including olaparib.
  19. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment. Patients who receive palliative radiotherapy need to stop radiotherapy 1 week before randomisation.
  20. Any previous exposure to a Cytochrome P450 (CYP) 17 (17α-hydroxylase/C17,20-lyase) inhibitor (eg, abiraterone, orteronel).
  21. Concomitant use of known strong Cytochrome P450 (CYP) 3A inhibitors (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks.
  22. Concomitant use of known strong Cytochrome P450 (CYP) 3A inducers (eg, phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine or St John's wort) or moderate Cytochrome P450 (CYP) 3A inducers (eg, bosentan, efavirenz or modafinil). The required period prior to starting study treatment is 5 weeks for phenobarbital and enzalutamide and 3 weeks for other agents.
  23. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
  24. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
  25. Participation in another clinical study with an investigational product or investigational medical devices within 1 month of randomisation.
  26. History of hypersensitivity to olaparib or abiraterone, any of the excipients of olaparib or abiraterone, or drugs with a similar chemical structure or class to olaparib or abiraterone.
  27. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and Merck staff and/or staff at the study site).
  28. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
  29. Previous randomisation in the present study.

Contact:

  • AstraZeneca Clinical Study Information Center
  • 1-877-240-9479

Locations:

  • Research Site
  • Homewood Alabama 35209 United States
  • Research Site
  • Anchorage Alaska 99503 United States
  • Research Site
  • Tucson Arizona 85704 United States
  • Research Site
  • Tucson Arizona 85741 United States
  • Research Site
  • Clovis California 93611 United States
  • Research Site
  • La Jolla California 92037 United States
  • Research Site
  • Los Angeles California 90027 United States
  • Research Site
  • Los Angeles California 90073 United States
  • Research Site
  • Sacramento California 95817 United States
  • Research Site
  • San Diego California 92123 United States
  • Research Site
  • Denver Colorado 80211 United States
  • Research Site
  • Norwich Connecticut 06360 United States
  • Research Site
  • Lisle Illinois 60532 United States
  • Research Site
  • Jeffersonville Indiana 47130 United States
  • Research Site
  • New Orleans Louisiana 70112 United States
  • Research Site
  • Towson Maryland 21204 United States
  • Research Site
  • Detroit Michigan 48202 United States
  • Research Site
  • Grand Rapids Michigan 49503 United States
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  • Saint Louis Missouri 63016 United States
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  • Bozeman Montana 59715 United States
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  • Omaha Nebraska 68130 United States
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  • Paramus New Jersey 07652 United States
  • Research Site
  • Brooklyn New York 11220 United States
  • Research Site
  • Fresh Meadows New York 11366 United States
  • Research Site
  • Lake Success New York 11042 United States
  • Research Site
  • Mineola New York 11501 United States
  • Research Site
  • Rochester New York 14642 United States
  • Research Site
  • Syracuse New York 13210 United States
  • Research Site
  • White Plains New York 10601 United States
  • Research Site
  • Durham North Carolina 27710 United States
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  • Middleburg Heights Ohio 44130 United States
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  • Portland Oregon 97239 United States
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  • Philadelphia Pennsylvania 19111 United States
  • Research Site
  • Charleston South Carolina 29425 United States
  • Research Site
  • Myrtle Beach South Carolina 29572 United States
  • Research Site
  • San Antonio Texas 78229 United States
  • Research Site
  • Seattle Washington 98109 United States
  • Research Site
  • Wheeling West Virginia 26041 United States
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  • Milwaukee Wisconsin 53149 United States
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  • Box Hill 3128 Australia
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  • Darlinghurst 2010 Australia
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  • Greenslopes 4120 Australia
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  • Herston 4029 Australia
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  • Kingswood 2747 Australia
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  • Kurralta Park 5037 Australia
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  • St Albans 3021 Australia
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  • Waratah 2298 Australia
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  • Brussels 1000 Belgium
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  • Brussels 1090 Belgium
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  • Gent 9000 Belgium
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  • Liège 4000 Belgium
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  • Belo Horizonte 30110-022 Brazil
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  • Curitiba 80810-050 Brazil
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  • Fortaleza 60336-232 Brazil
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  • Porto Alegre 90610-000 Brazil
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  • Porto Alegre 91350-200 Brazil
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  • Rio de Janeiro 22793-080 Brazil
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  • Sao Paulo 01221-020 Brazil
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  • São José do Rio Preto 15090-000 Brazil
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  • Calgary Alberta T2V 1P9 Canada
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  • Edmonton Alberta T6G 1Z2 Canada
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  • Kelowna British Columbia V1Y 5L3 Canada
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  • Toronto CA M5G 2M9 Canada
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  • Halifax Nova Scotia B3H 1V7 Canada
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  • London Ontario N6A 5W9 Canada
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  • Toronto Ontario M4N 3M5 Canada
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  • Greenfield Park Quebec J4V 2H1 Canada
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  • Montreal Quebec H2X 3E4 Canada
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  • Montreal Quebec H3T 1E2 Canada
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  • Santiago 7500787 Chile
  • Research Site
  • Santiago 7520349 Chile
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  • Temuco 4781156 Chile
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  • Viña del Mar 2540488 Chile
  • Research Site
  • Beijing 100034 China
  • Research Site
  • Beijing 100050 China
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  • Beijing 100191 China
  • Research Site
  • Beijing 100730 China
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  • Changsha 410008 China
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  • Changsha 410013 China
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  • Chengdu 610041 China
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  • ChongQing 400038 China
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  • Hangzhou 310009 China
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  • Hangzhou 310014 China
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  • Hangzhou 310022 China
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  • Nanchang 330006 China
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  • Nanjing 2100008 China
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  • Shanghai 200032 China
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  • Shanghai 200040 China
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  • Shanghai 200127 China
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  • Xi'an 710061 China
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  • Xiamen 361003 China
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  • Brno 656 53 Czechia
  • Research Site
  • Hradec Kralove 500 05 Czechia
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  • Praha 5 150 06 Czechia
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  • Praha 120 00 Czechia
  • Research Site
  • Angers Cedex 01 49033 France
  • Research Site
  • BESANCON Cedex 25030 France
  • Research Site
  • Caen Cedex 05 14076 France
  • Research Site
  • Marseille 13003 France
  • Research Site
  • Pierre Benite 69495 France
  • Research Site
  • Quimper Cedex 29107 France
  • Research Site
  • Toulouse Cedex 3 31076 France
  • Research Site
  • Bergisch Gladbach 51465 Germany
  • Research Site
  • Bremen 28277 Germany
  • Research Site
  • Duisburg 47179 Germany
  • Research Site
  • Freiburg im Breisgau 79106 Germany
  • Research Site
  • Hannover 30625 Germany
  • Research Site
  • Heinsberg 52525 Germany
  • Research Site
  • Köln 50968 Germany
  • Research Site
  • Mettmann 40822 Germany
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  • Nürnberg 90419 Germany
  • Research Site
  • Nürtingen 72622 Germany
  • Research Site
  • Ulm 89081 Germany
  • Research Site
  • Milano 20133 Italy
  • Research Site
  • Milano 20141 Italy
  • Research Site
  • Napoli 80131 Italy
  • Research Site
  • Orbassano 10043 Italy
  • Research Site
  • Pavia 27100 Italy
  • Research Site
  • Roma 00152 Italy
  • Research Site
  • Trento 38100 Italy
  • Research Site
  • Bunkyo-ku 113-8431 Japan
  • Research Site
  • Hirakata-shi 573-1191 Japan
  • Research Site
  • Kashihara-shi 634-8522 Japan
  • Research Site
  • Kawagoe-shi 350-8550 Japan
  • Research Site
  • Kita-gun 761-0793 Japan
  • Research Site
  • Kyoto-shi 606-8507 Japan
  • Research Site
  • Maebashi-shi 371-8811 Japan
  • Research Site
  • Nagoya-shi 466-8560 Japan
  • Research Site
  • Osaka-shi 541-8567 Japan
  • Research Site
  • Osaka-shi 545-0051 Japan
  • Research Site
  • Osakasayama-shi 589-8511 Japan
  • Research Site
  • Sagamihara-shi 252-0375 Japan
  • Research Site
  • Sakura-shi 285-8741 Japan
  • Research Site
  • Shinjuku-ku 160-8582 Japan
  • Research Site
  • Toon-shi 791-0295 Japan
  • Research Site
  • Yokohama-shi 232-0024 Japan
  • Research Site
  • Daegu 41404 Korea, Republic of
  • Research Site
  • Goyang-si 10408 Korea, Republic of
  • Research Site
  • Seoul 03080 Korea, Republic of
  • Research Site
  • Seoul 03722 Korea, Republic of
  • Research Site
  • Seoul 05505 Korea, Republic of
  • Research Site
  • Seoul 06591 Korea, Republic of
  • Research Site
  • Hilversum 1213 XZ Netherlands
  • Research Site
  • Nijmegen 6525 GA Netherlands
  • Research Site
  • Tilburg 5042 AD Netherlands
  • Research Site
  • Bratislava 851 05 Slovakia
  • Research Site
  • Nitra 49401 Slovakia
  • Research Site
  • Presov 08001 Slovakia
  • Research Site
  • Sala 92701 Slovakia
  • Research Site
  • Trencin 91101 Slovakia
  • Research Site
  • Barcelona 08035 Spain
  • Research Site
  • Barcelona 08036 Spain
  • Research Site
  • Gerona 17007 Spain
  • Research Site
  • Madrid 28041 Spain
  • Research Site
  • Malaga 29010 Spain
  • Research Site
  • Sevilla 41009 Spain
  • Research Site
  • Adana Turkey
  • Research Site
  • Ankara 06590 Turkey
  • Research Site
  • Ankara 06800 Turkey
  • Research Site
  • Istanbul 34030 Turkey
  • Research Site
  • Izmir 35360 Turkey
  • Research Site
  • Karsiyaka 35575 Turkey
  • Research Site
  • Blackburn BB2 3HH United Kingdom
  • Research Site
  • Guildford GU2 5XX United Kingdom
  • Research Site
  • Manchester M20 4BX United Kingdom
  • Research Site
  • Sheffield S10 2SJ United Kingdom
  • Research Site
  • Southampton SO16 6YD United Kingdom
  • Research Site
  • Swansea SA2 8QA United Kingdom

View trial on ClinicalTrials.gov


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