Prostate Cancer

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HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer


Condition: Prostate Cancer

Intervention:

  • Drug: Relugolix
  • Drug: Leuprolide Acetate

Purpose: The purpose of this study is to determine the benefit and safety of relugolix 120 mg orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (<=50 ng/dL [1.7 nmol/L] in patients with androgen-sensitive advanced prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03085095

Sponsor: Myovant Sciences GmbH

Primary Outcome Measures:

  • Measure: Sustained Castration Rate
  • Time Frame: 48 weeks
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Castration Rate by Visit
  • Time Frame: 1, 2, and3 weeks
  • Safety Issue:

Estimated Enrollment: 915

Study Start Date: March 3, 2017

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Key Inclusion Criteria:

  1. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate;
  2. Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with one of the following clinical disease state presentations:
  3. Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound and not a candidate for salvage treatment by surgery (radiotherapy, cryotherapy, or high frequency ultrasound are allowed after 2 months of androgen deprivation therapy); or
  4. Newly diagnosed androgen-sensitive metastatic disease; or
  5. Advanced localized disease not suitable for local primary surgical intervention with curative intent (radiotherapy, cryotherapy, or high frequency ultrasound are allowed after 2 months of androgen deprivation therapy);
  6. Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nmol/L);
  7. Has a serum PSA concentration at the Screening visit of > 2.0 ng/mL (2.0 μg/L), or, when applicable, post radical prostatectomy of > 0.2 ng/mL (0.2 μg/L) or post radiotherapy, cryotherapy, or high frequency ultrasound > 2.0 ng/mL (2.0 μg/L) above the post interventional nadir;
  8. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at initial screening and at baseline.

Key Exclusion Criteria:

  1. In the investigator's opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy;
  2. Previously received GnRH analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for > 18 months total duration. If androgen deprivation therapy was received for ≤ 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline. If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot;
  3. Previous systemic cytotoxic treatment for prostate cancer (eg: taxane-based regimen);
  4. Metastases to brain per prior clinical evaluation;
  5. Scheduled for major surgery after baseline;
  6. History of surgical castration.

Contact:

  • Clinical Trials at Myovant
  • 650-278-8743

Locations:

  • Homewood
  • Homewood Alabama 35209 United States
  • Anchorage
  • Anchorage Alaska 99503 United States
  • Tucson
  • Tucson Arizona 85741 United States
  • San Diego
  • San Diego California 92120 United States
  • Denver
  • Denver Colorado 80211 United States
  • Pompano Beach
  • Pompano Beach Florida 33060 United States
  • Jeffersonville
  • Jeffersonville Indiana 47130 United States
  • Des Moines
  • Des Moines Iowa 50266 United States
  • Wichita
  • Wichita Kansas 67226 United States
  • Towson
  • Towson Maryland 21204 United States
  • Troy
  • Troy Michigan 48084 United States
  • Omaha
  • Omaha Nebraska 68130 United States
  • Las Vegas
  • Las Vegas Nevada 89135 United States
  • Brick
  • Brick New Jersey 08724 United States
  • Lawrenceville
  • Lawrenceville New Jersey 08648 United States
  • Albuquerque
  • Albuquerque New Mexico 87109 United States
  • Brooklyn
  • Brooklyn New York 11215 United States
  • Garden City
  • Garden City New York 11530 United States
  • New York
  • New York New York 10029 United States
  • Plainview
  • Plainview New York 11803 United States
  • Poughkeepsie
  • Poughkeepsie New York 12601 United States
  • Syracuse
  • Syracuse New York 13210 United States
  • Durham
  • Durham North Carolina 27710 United States
  • Winston-Salem
  • Winston-Salem North Carolina 27157 United States
  • Cincinnati
  • Cincinnati Ohio 45212 United States
  • MiddleBurg Heights
  • Middleburg Heights Ohio 44130 United States
  • Toledo
  • Toledo Ohio 43614 United States
  • Oklahoma City
  • Oklahoma City Oklahoma 73104 United States
  • Lancaster
  • Lancaster Pennsylvania 17604 United States
  • Myrtle Beach
  • Myrtle Beach South Carolina 29572 United States
  • Nashville
  • Nashville Tennessee 37209 United States
  • Dallas
  • Dallas Texas 75231 United States
  • San Antonio
  • San Antonio Texas 78229 United States
  • Virginia Beach
  • Virginia Beach Virginia 23462 United States
  • Camperdown
  • Camperdown New South Wales 2050 Australia
  • Darlinghurst
  • Darlinghurst New South Wales 2010 Australia
  • Tweed Heads
  • Tweed Heads New South Wales 2485 Australia
  • Wahroonga
  • Wahroonga New South Wales 2076 Australia
  • Cairns
  • Cairns Queensland 4870 Australia
  • Redcliffe
  • Redcliffe Queensland 4020 Australia
  • Geelong
  • Geelong Victoria 3220 Australia
  • Linz
  • Linz A-4010 Austria
  • Salzburg
  • Salzburg 5020 Austria
  • Edegem
  • Edegem Antwerpen 2650 Belgium
  • Gent
  • Gent Oost-Vlaanderen 9000 Belgium
  • Leuven
  • Leuven Vlaams Brabant 3000 Belgium
  • Brussels
  • Brussels 1200 Belgium
  • Kortrijk
  • Kortrijk 8500 Belgium
  • Itabuna
  • Itabuna Bahia 45602 Brazil
  • Salvador
  • Salvador Bahia 40050 Brazil
  • Salvador
  • Salvador Bahia 41820 Brazil
  • Curitiba
  • Curitiba Paraná 80530 Brazil
  • Teresina
  • Teresina Piauí 64001 Brazil
  • Natal
  • Natal Rio Grande Do Norte 59062 Brazil
  • Ijuí
  • Ijuí Rio Grande Do Sul 98700 Brazil
  • Passo Fundo
  • Passo Fundo Rio Grande Do Sul 99010-260 Brazil
  • Porto Alegre
  • Porto Alegre Rio Grande Do Sul 90035-903 Brazil
  • Porto Alegre
  • Porto Alegre Rio Grande Do Sul 90110-270 Brazil
  • Porto Alegre
  • Porto Alegre Rio Grande Do Sul 90430-090 Brazil
  • Porto Alegre
  • Porto Alegre Rio Grande Do Sul 90610 Brazil
  • Joinville
  • Joinville Santa Catarina 89201 Brazil
  • São José Do Rio Preto
  • São José Do Rio Preto Sao Paulo 15090 Brazil
  • São Paulo
  • São Paulo 01406 Brazil
  • Calgary
  • Calgary Alberta T2V1P9 Canada
  • Vancouver
  • Vancouver British Columbia V5Z1M9 Canada
  • Halifax
  • Halifax Nova Scotia B3H2Y9 Canada
  • Hamilton
  • Hamilton Ontario L8N4A6 Canada
  • London
  • London Ontario N6A5W9 Canada
  • Montreal
  • Montréal Quebec H2X0A9 Canada
  • Sherbrooke
  • Sherbrooke Quebec J1H5N4 Canada
  • Toronto
  • Toronto Quebec H2X0A9 Canada
  • Quebec
  • Quebec Canada
  • Alborg
  • Aalborg Nordjylland DK-9000 Denmark
  • Aarhus
  • Aarhus 8200 Denmark
  • Copenhagen
  • Copenhagen 2200 Denmark
  • Herlev
  • Herlev 2730 Denmark
  • Vejle
  • Vejle DK-7100 Denmark
  • Helsinki
  • Helsinki 00029 HUS Finland
  • Seinajoki
  • Seinäjoki FI-60220 Finland
  • Tampere
  • Tampere FI-33520 Finland
  • Turku
  • Turku FI-20520 Finland
  • Strasbourg
  • Strasbourg Bas-Rhin 67091 France
  • Marseille
  • Marseille Bouches-du-Rhône 13385 France
  • Lille
  • Lille Nord 59037 France
  • Pierre Benite
  • Pierre-Bénite Rhone 69495 France
  • Creteil
  • Créteil Val De Marne 94010 France
  • Creteil
  • Créteil Val-de-Marne 94010 France
  • Hyeres
  • Hyères 83400 France
  • Lyon
  • Lyon 69437 France
  • Nimes
  • Nîmes 30029 France
  • Poitiers
  • Poitiers 86021 France
  • Emmendingen
  • Emmendingen Baden-Wurttemberg 79312 Germany
  • Planegg
  • Planegg Bayern 82152 Germany
  • Braunscheweig
  • Braunschweig Niedersachsen 38100 Germany
  • Braunschweig
  • Braunschweig Niedersachsen 38100 Germany
  • Braunschweig
  • Braunschweig Niedersachsen 38126 Germany
  • Dresden
  • Dresden 01307 Germany
  • Hamburg
  • Hamburg 22399 Germany
  • Lubeck
  • Lübeck 23538 Germany
  • Munster
  • Münster 48149 Germany
  • Meldola
  • Meldola Emilia-Romagna 47014 Italy
  • Rome
  • Rome Lazio 00152 Italy
  • Candiolo
  • Candiolo Piemonte 10060 Italy
  • Orbassano
  • Orbassano Piemonte 10043 Italy
  • Arezzo
  • Arezzo Toscana 00152 Italy
  • Milano
  • Milano 20162 Italy
  • Pavia
  • Pavia 27100 Italy
  • Kanazawa-shi
  • Kanazawa-shi Isikawa 920-8641 Japan
  • Sendai
  • Sendai Miyagi 9808574 Japan
  • Sendai
  • Sendai Miyagi 9818563 Japan
  • Suita
  • Suita Osaka 565-0871 Japan
  • Osaka-sayama City
  • Ōsaka-sayama Osaka 589-8511 Japan
  • Fukuoka
  • Fukuoka 812-0033 Japan
  • Hiroshima
  • Hiroshima 730-8518 Japan
  • Hiroshima
  • Hiroshima 7308518 Japan
  • Kita-gun
  • Kita 761093 Japan
  • Kyoto
  • Kyoto 606-8507 Japan
  • Maebashi-shi
  • Maebashi 371-8511 Japan
  • Nagasaki-shi
  • Nagasaki Japan
  • Osaka
  • Osaka Japan
  • Sapporo
  • Sapporo 003-0804 Japan
  • Sapporo
  • Sapporo 0030804 Japan
  • Tokyo
  • Tokyo 285-8741 Japan
  • Tokyo
  • Tokyo Japan
  • Ube-shi
  • Ube 7558505 Japan
  • Yokohama City
  • Yokohama Japan
  • Ōsaka-sayama
  • Ōsaka-sayama Ôsaka 589-8511 Japan
  • Busan
  • Busan 49241 Korea, Republic of
  • Hwasun-gun
  • Hwasun 58128 Korea, Republic of
  • Hwasun-gun
  • Hwasun Korea, Republic of
  • Seongnam
  • Seongnam 13620 Korea, Republic of
  • Seoul
  • Seoul 03722 Korea, Republic of
  • Seoul
  • Seoul 05505 Korea, Republic of
  • Seoul
  • Seoul 06351 Korea, Republic of
  • Seoul
  • Seoul 13572 Korea, Republic of
  • Maastricht
  • Maastricht 6229HX Netherlands
  • Sneek
  • Sneek 8601 ZK Netherlands
  • Hamilton
  • Hamilton Northland 3204 New Zealand
  • Dunedin
  • Dunedin South Island 9001 New Zealand
  • Canterbury
  • Christchurch 8013 New Zealand
  • Tauranga
  • Tauranga 3140 New Zealand
  • Wroclaw
  • Wrocław Dolnoslaskie 53114 Poland
  • Gdynia
  • Gdynia Lubelskie 20-582 Poland
  • Lublin
  • Lublin Lubelskie 20582 Poland
  • Siedlce
  • Siedlce Mazowieckie 08110 Poland
  • Warszawa
  • Warszawa Mazowieckie 02-797 Poland
  • Gdynia
  • Gdynia 81-519 Poland
  • Gdynia
  • Gdynia 81519 Poland
  • Katowice
  • Katowice 40611 Poland
  • Bratislava
  • Bratislava 845 05 Slovakia
  • Kosice
  • Košice 04001 Slovakia
  • Martin
  • Martin Slovakia
  • Nitra
  • Nitra 94901 Slovakia
  • Poprad
  • Poprad Slovakia
  • Presov
  • Prešov 080 01 Slovakia
  • Trencin
  • Trenčín 911 01 Slovakia
  • Sula
  • Šula 927 01 Slovakia
  • A Coruna
  • A Coruña A Coruna 15006 Spain
  • Oviedo
  • Oviedo Asturias 33011 Spain
  • Barcelona
  • Barcelona 8036 Spain
  • Barcelona
  • Barcelona Spain
  • Madrid
  • Madrid 28006 Spain
  • Madrid
  • Madrid 28041 Spain
  • Sabadell
  • Sabadell 08208 Spain
  • Salamanca
  • Salamanca 37007 Spain
  • Santiago de Compostela
  • Santiago de Compostela 15706 Spain
  • Valencia
  • Valencia 46009 Spain
  • Orebro
  • Örebro Orebro Ian SE-70185 Sweden
  • Malmo
  • Malmö Skane Ian Sweden
  • Stockholm
  • Stockholm Sodermandlands Ian Sweden
  • Uppsala
  • Uppsala 751 85 Sweden
  • Kaohsiung
  • Kaohsiung Taiwan
  • Taipei
  • Taipei 112 Taiwan
  • Taipei
  • Taipei 11490 Taiwan
  • Taipei
  • Taipei Taiwan
  • Wirral
  • Wirral Cheshire CH63 4JY United Kingdom
  • Glasgow
  • Glasgow Glasgow City G12 0YN United Kingdom
  • Scunthorpe
  • Scunthorpe North Lincolnshire DN157BH United Kingdom
  • Aberdeen
  • Aberdeen AB25 2ZN United Kingdom
  • Aberdeen
  • Aberdeen AB252ZN United Kingdom
  • Nottingham
  • Nottingham NG5 1PB United Kingdom
  • Plymouth
  • Plymouth PL6 8DH United Kingdom
  • Plymouth
  • Plymouth PL68DH United Kingdom
  • Wrexham
  • Wrexham United Kingdom

View trial on ClinicalTrials.gov


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TheraP: A Randomised Phase 2 Trial of 177Lu-PSMA617 Theranostic Versus Cabazitaxel in Progressive Metastatic Castration Resistant Prostate Cancer (ANZUP Protocol 1603)


Condition: Cancer of the Prostate, Metastatic Cancer

Intervention:

  • Other: 177Lu-PSMA617
  • Drug: Cabazitaxel

Purpose: This open label, randomised, stratified, 2-arm, multicentre, phase 2 trial aims to determine the activity and safety of Lu-PSMA vs cabazitaxel in men with progressive metastatic castration resistant prostate cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03392428

Sponsor: Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Primary Outcome Measures:

  • Measure: Prostate Specific Antigen response rate (PSA RR)
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Pain Response (PPI and Analgesic Score)
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: Objective Tumour Response Rate
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: Progression free survival
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: PSA progression free survival
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: Pain progression free survival
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: Radiographic progression free survival
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: Health-related quality of life
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: Frequency and severity of adverse events
  • Time Frame: From first study dose to 12 weeks after completing study treatment
  • Safety Issue:

Estimated Enrollment: 200

Study Start Date: January 29, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 1. Male aged 18 or older with metastatic adenocarcinoma of the prostate defined by:
  • Documented histopathology of prostate adenocarcinoma OR
  • Metastatic disease typical of prostate cancer (i.e. involving bone or pelvic lymph nodes or para-aortic lymph nodes) 2. Castration-resistant prostate cancer (defined as disease progressing despite castration by orchiectomy or ongoing Luteinizing Hormone-Releasing Hormone (LHRH) analog 3. Progressive disease with rising PSA on 3 consecutive measurements, and PSA ≥ 20 ng/mL 4. Target or non-target lesions according to RECIST 1.1 5. Prior treatment with docetaxel 6. Significant PSMA avidity on 68Ga-PSMA PET/CT, defined as a minimum uptake of SUVmax 20 at a site of disease, and SUVmax > 10 at sites of measurable disease ≥10mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact) 7. ECOG Performance status 0 to 2 8. Assessed by a medical oncologist as suitable for chemotherapy with cabazitaxel 9. Adequate renal function: • Cr Cl ≥ 40mL/min (Cockcroft-Gault formula) 10. Adequate bone marrow function:
  • Platelets ≥ 100 x10 billion /L
  • Hb ≥ 90g/L (no red blood cell transfusion in last 4 weeks)
  • Neutrophils > 1.5 x10 billion/L 11. Adequate liver function:
  • Bilirubin < 1.5 x upper limit of normal (ULN) (or if bilirubin is between 1.5-2x ULN, must have a normal conjugated bilirubin)
  • AST or ALT ≤ 2.0 x ULN (or ≤ 5.0 x ULN in the presence of liver metastases) 12. Estimated life expectancy > 12 weeks 13. Study treatment both planned and able to start within 21 days of randomisation 14. Willing and able to comply with all study requirements, including all treatments (cabazitaxel or Lu-PSMA); and, the timing and nature of all required assessments 15. Signed, written informed consent

Exclusion Criteria:

  1. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
  2. Site(s) of disease that are FDG positive with minimal PSMA expression defined as FDG intensity > 68Ga-PSMA activity OR 68Ga-PSMA SUVmax < 10
  3. Sjogren's syndrome
  4. Prior treatment with cabazitaxel or Lu-PSMA
  5. Contraindications to the use of corticosteroid treatment
  6. Active malignancy other than prostate cancer
  7. Concurrent illness, including severe infection that may jeopardise the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
  8. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
  9. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception

Contact:

  • Trial Coordinator
  • 61295625363

Locations:

  • Liverpool Hospital
  • Liverpool New South Wales 2170 Australia
  • St Vincent's Hospital
  • Sydney New South Wales 2010 Australia
  • Royal North Shore Hospital
  • Sydney New South Wales 2065 Australia
  • Royal Brisbane and Womens Hospital
  • Brisbane Queensland 4029 Australia
  • Royal Adelaide Hospital
  • Adelaide South Australia 5000 Australia
  • Peter MacCallum Cancer Centre
  • Melbourne Victoria 3008 Australia
  • Austin Hospital
  • Melbourne Victoria 3084 Australia
  • Monash Moorabbin Hospital
  • Moorabbin Victoria 3165 Australia
  • Fiona Stanley Hospital
  • Murdoch Western Australia 6450 Australia
  • Sir Charles Gairdner Hospital
  • Nedlands Western Australia 6009 Australia

View trial on ClinicalTrials.gov


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Phase 2 Open Label Study of Pembrolizumab in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without DNA Damage Repair Defects


Condition: Castration Resistant Prostatic Cancer, Metastatic Prostate Cancer

Intervention:

  • Drug: Pembrolizumab
  • Drug: Chemotherapy

Purpose: This is a multicenter phase 2 open label study of pembrolizumab in patients with metastatic castrate resistant prostate cancer (mCRPC) with or without DNA damage repair defects.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03248570

Sponsor: University of California, San Francisco

Primary Outcome Measures:

  • Measure: Objective response rate (ORR)
  • Time Frame: From baseline until complete response, progression on repeat pembrolizumab, or date of death from any cause, whichever comes first, up to 24 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Immune-related progression-free survival (irPFS)
  • Time Frame: At 20 weeks and 28 weeks
  • Safety Issue:
  • Measure: Progression-free survival (PFS)
  • Time Frame: At 20 weeks and 28 weeks
  • Safety Issue:
  • Measure: Proportion of subjects achieving any prostate specific antigen (PSA) response
  • Time Frame: From baseline until complete response, progression on repeat pembrolizumab, or date of death from any cause, whichever comes first, up to 24 months
  • Safety Issue:
  • Measure: Proportion of subjects achieving any PSA decline ≥ 50%
  • Time Frame: From baseline until complete response, progression on repeat pembrolizumab, or date of death from any cause, whichever comes first, up to 24 months
  • Safety Issue:
  • Measure: Safety of pembrolizumab
  • Time Frame: From baseline until 30 days after end of treatment (at complete response, progression on repeat pembrolizumab, or date of death from any cause, whichever comes first, up to 24 months)
  • Safety Issue:
  • Measure: Time to progression after taxane-based chemotherapy
  • Time Frame: From completion of taxane-based chemotherapy to progression, up to 24 months
  • Safety Issue:

Estimated Enrollment: 50

Study Start Date: February 20, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Histologically documented adenocarcinoma of the prostate.
  2. Metastatic castration resistant prostate cancer with castrate-level testosterone (<50 ng/dL). a. Subjects must maintain a castrate-level testosterone during the study.
  3. Disease progression defined by one or more of the following three criteria:
  4. PSA > 2.0 ng/mL and rising PSA by at least 2 consecutive measurements a minimum of 1-week apart.
  5. Soft tissue progression as defined by RECIST v1.1 criteria
  6. Bone disease progression as defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
  7. Have measurable disease based on RECIST v.1.1 and irRC for response assessment. a. Must have at least one lesion that is 10mm in longest diameter for a soft tissue lesion or 15mm in short axis for a lymph node.
  8. Have received prior abiraterone and/or enzalutamide.
  9. Be willing and able to provide written informed consent/assent for the trial.
  10. Be ≥ 18 years of age on day of signing informed consent.
  11. Be willing to provide archival tissue from prior biopsy or surgery for prostate cancer, if available.
  12. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
  13. Patients must discontinue antiandrogen therapy (i.e. bicalutamide, flutamide, nilutamide) at least 4-6 weeks prior to registration with no evidence of PSA decline after washout.
  14. Bicalutamide: Washout period at least 6 weeks
  15. Flutamide and nilutamide: Washout period at least 4 weeks
  16. Patients must discontinue therapies for mCRPC, with the exception of Gonadotropin-releasing hormone (GnRH) agent, for 5 half-lives or 28 days, whichever is shorter.
  17. For patients on abiraterone/prednisone, prednisone should be discontinued for at least 7 days before starting study treatment.
  18. Prior chemotherapy is allowed if no progression of disease on chemotherapy.
  19. Prior treatment with sipuleucel-T, radium-223, or poly adenosine diphosphate (ADP) ribose polymerase (PARP) inhibitor (e.g. olaparib) is allowed.
  20. Tissue biopsy may be performed during washout period.
  21. Demonstrate adequate organ function as defined as follows, all screening labs should be performed within 10 days of treatment initiation. a. Hematological i. Absolute neutrophil count (ANC): ≥ 1,500 /microliters (mcL) ii. Platelets: ≥ 100,000 / mcL iii. Hemoglobin: ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment) b. Renal i. Serum creatinine OR Measured or calculated a creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤ 1.5 X upper limit of normal (ULN) OR ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN c. Hepatic i. Serum total bilirubin: ≤ 1.5 X ULN ii. Aspartate Aminotransferase (AST) (SGOT) and Alanine Aminotransferase (ALT) (SGPT): ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases iii. Albumin: > 2.5 mg/dL d. Coagulation i. International Normalized Ratio (INR) or Prothrombin Time (PT): ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or Partial Thromboplastin Time (PTT) is within therapeutic range of intended use of anticoagulants ii. Activated Partial Thromboplastin Time (aPTT): ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  22. Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Exclusion Criteria:

  1. Significant liver metastasis or disease-related bone pain requiring scheduled narcotics.
  2. Prior taxane-based chemotherapy with progressive disease on chemotherapy.
  3. Prior docetaxel for metastatic hormone sensitive prostate cancer is allowed, if no progression of disease on docetaxel as defined by RECIST v1.1 and PCWG
  4. Prior taxane-based chemotherapy (i.e. docetaxel or cabazitaxel with or without platinum agent) for mCRPC is allowed if no progression of disease on chemotherapy as defined by RECIST v1.1 and PCWG
  5. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  6. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy >10mg/day or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  7. Has a known history of active Bacillus Tuberculosis (TB).
  8. Hypersensitivity to pembrolizumab or any of its excipients.
  9. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  10. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  11. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  12. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  13. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  14. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  15. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy < 10 mg of prednisone/day for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  16. Has known history of, or any evidence of active, non-infectious pneumonitis.
  17. Has an active infection requiring systemic therapy.
  18. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  19. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  20. Is expecting to father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  21. Has received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-PD-L1, or anti-PD-L2 agent.
  22. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  23. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., hepatitis C virus [HCV] RNA [qualitative] is detected).
  24. Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

Contact:

  • Paula Dutton
  • 877-827-3222

Location:

  • UCSF Helen Diller Family Comprehensive Cancer Center
  • San Francisco California 94115 United States

View trial on ClinicalTrials.gov


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A Phase II Randomized, Open-Label, Two-Arm Study of a Low-Fat Diet With Fish Oil Capsules vs. a Control Group in Men on Active Surveillance for Prostate Cancer


Condition: Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Intervention:

  • Behavioral: behavioral dietary intervention
  • Behavioral: behavioral dietary intervention
  • Dietary Supplement: omega-3 fatty acid
  • Other: laboratory biomarker analysis

Purpose: This randomized phase II trial will evaluate if a low-fat diet with fish oil has the potential to delay disease progression in patients with prostate cancer undergoing active surveillance.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02176902

Sponsor: Jonsson Comprehensive Cancer Center

Primary Outcome Measures:

  • Measure: Decipher score in one year prostate biopsy tissue sample
  • Time Frame: 1 year
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Composite measure: Prostate biopsy tissue markers of proliferation, cell cycle progression, and prostate biopsy pathologic features (Gleason grade, percent of cores with cancer, and percent of tissue with cancer)
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Serum PSA
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Composite measure: Long-term clinical outcomes (clinical progression, prostate cancer therapies)
  • Time Frame: Up to 15 years
  • Safety Issue:
  • Measure: Composite measure: Potential surrogate biomarkers of proliferation (RBC membrane fatty acid analyses, ex-vivo bioassay)
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Correlation of GPR120 expression in peripheral blood mononuclear cells (PBMCs) and prostate biopsy tissue with immunostaining of Ki67 and Decipher Score
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Compliance, defined as having taken 80% or more of the daily fish oil throughout the trial determined based on pill count
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Incidence of adverse events graded according to National Cancer Institute Common Toxicity Criteria version 4.0
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Sample storage for future research
  • Time Frame: Up to 1 year
  • Safety Issue:

Estimated Enrollment: 100

Study Start Date: November 1, 2014

Eligibility:

  • Age: minimum 50 Years maximum 80 Years
  • Gender: Male

Inclusion Criteria:

  • Patients sign the informed consent
  • Patient had a prostate biopsy performed by Dr. Mark with the Artemis device and has adenocarcinoma of the prostate
  • Patient elects to undergo active surveillance
  • Clinical stage T2c or less
  • Gleason grade 3+4 or less
  • PSA < 20
  • Geographically able to have study visits at the University of California, Los Angeles (UCLA) Clinical Research Unit
  • Subjects are willing to not consume lycopene, green tea or pomegranate supplements or pomegranate juice during the 1-year study
  • If subjects are randomized to the control group they agree to not consume fish oil capsules during the 1-year study

Exclusion Criteria:

  • Diagnostic prostate biopsy with only 1 core with cancer and < 5% of tissue from that core involved with cancer
  • Patient has taken finasteride or dutasteride during the prior year
  • Patient has taken fish oil during the prior 3 months
  • Patient had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy)
  • Patient has other medical conditions that exclude him from undergoing a repeat prostate biopsy at 1-year
  • Patient has allergy to fish

Location:

  • Jonsson Comprehensive Cancer Center
  • Los Angeles California 90095 United States

View trial on ClinicalTrials.gov


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PROVENT: A Randomised, Double Blind, Placebo Controlled Feasibility Study to Examine the Clinical Effectiveness of Aspirin and/or Vitamin D3 to Prevent Disease Progression in Men on Active Surveillance for Prostate Cancer


Condition: Prostate Cancer

Intervention:

  • Drug: High dose Aspirin & Vitamin D
  • Drug: High dose Aspirin, Vitamin D placebo
  • Drug: Low dose Aspirin , Vitamin D
  • Drug: Low dose Aspirin, Vitamin D placebo
  • Drug: Aspirin Placebo, Vitamin D
  • Drug: Aspirin placebo, Vitamin D placebo

Purpose: To demonstrate the acceptability and feasibility of recruitment to a randomised chemoprevention study of standard (300mg) or low dose (100mg) aspirin vs. placebo and/or Vitamin D3 vs. placebo in patients enrolled on an Active Surveillance programme for prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03103152

Sponsor: Queen Mary University of London

Primary Outcome Measures:

  • Measure: Rate of patient recruitment to a randomised chemoprevention study in men enrolled on an Active Surveillance programme for prostate cancer. Number accrued per month.
  • Time Frame: 18 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Response to treatment as determined by serial multi-parametric magnetic resonance imaging (MRI) of the prostate. New lesion present or existing lesion + or - in size.
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Biochemical disease progression. 50% increase in serum Prostate Specific Antigen at 12 months from baseline.
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Histological disease progression. Increase in Gleason score or MCCL
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Toxicity and/or allergy to both aspirin and Vitamin D3; Symptoms of Aspirin or Vit D toxicity.
  • Time Frame: 3 years
  • Safety Issue:

Estimated Enrollment: 102

Study Start Date: December 2016

Phase: Phase 2/Phase 3

Eligibility:

  • Age: minimum 16 Years maximum 100 Years
  • Gender: Male

Inclusion Criteria:

  • 1. Male subjects aged 16 years or over with an estimated life expectancy of more than three years 2. Willing and able to provide written informed consent 3. Corrected serum calcium <2.65mmol/l 4. No previous treatment for prostate cancer (including surgery, hormone therapy, radiotherapy, cryotherapy) 5. All subjects must have had Magnetic Resonance Imaging (MRI) of the prostate with targeted biopsy of any lesions identified 6. Histologically confirmed prostate cancer* following prostate biopsy (including at least 10 cores of prostate tissue) in men opting for Active Surveillance as their primary cancer therapy.
  • *PROVENT Prostate Cancer Criteria for Inclusion:
  • Gleason score 6 or 7
  • Clinical and radiological stage
  • Serum PSA ≤15.0 ng/ml
  • Less than 10mm of cancer in a single core Patients must have undergone a multi-parametric MRI deemed assessable by the local radiologist, and any lesions seen must have undergone targeted biopsy (transrectal or transperineal) within 12 months of study enrolment.

Exclusion Criteria:

  1. Previously treated prostate cancer (including radiotherapy, hormone therapy, brachytherapy or surgery)
  2. Current enrolment in an investigational drug, device or other clinical research study or participation in such a study within 30 days of randomisation
  3. Current daily use of aspirin or NSAIDs; or daily dietary supplements/medication containing more than 400 IU (10 micrograms per day) Vitamin D3; or chronic use (defined as > 6 months continuous daily use) of either aspirin or replacement Vitamin D3 within two years of study enrolment
  4. Current or previous use of 5-α reductase inhibitors such as finasteride or dutasteride
  5. Not willing to comply with the procedural requirements of this protocol including repeat prostate biopsies
  6. Known allergy/sensitivity to or intolerance of aspirin, other salicylates or NSAIDs e.g. ibuprofen/ naproxen
  7. Prior history of gastro-intestinal bleeding or ulceration, severe dyspepsia or inflammatory bowel disease
  8. Haemophilia or other bleeding diatheses
  9. Prior history of renal stone disease
  10. Chronic renal disease (≥stage 4)
  11. Known hypercalcaemia (corrected serum calcium >2.65 mmol/l) or untreated hyperparathyroidism
  12. Any bowel condition that would make repeat transrectal biopsy hazardous or difficult to perform e.g. recto-urethral fistula, or prior bowel surgery such as abdomino-perineal resection.
  13. Any malignancy (other than non-melanoma skin cancer) that has not been in complete remission for five years
  14. Any serious co-existent medical condition that would make repeat prostate biopsy hazardous e.g. anti-coagulation requiring continuous administration
  15. Severe Asthma
  16. G6PD deficiency
  17. Pre-existing macular degeneration
  18. All contraindications to aspirin and Vitamin D3, including concomitant therapy with any medication that may interact with aspirin or Vitamin D3 (see section 4.10)
  19. Regular consumption of alcohol units greater than the recommended daily limit of 3-4 units per day (men)

Contact:

  • Thomas Powles, MD
  • 0207 882 8498

Locations:

  • University Hospital of Wales
  • London CF14 4XW United Kingdom
  • University Hospital UHCW NHS Trust
  • London CV2 2DX United Kingdom
  • St Bartholomews Hospital London, Bart's and the London school of Medicine
  • London EC1A 7BE United Kingdom
  • University College Hospital London
  • London NW1 2B United Kingdom
  • Guy's Hospital
  • London United Kingdom
  • Homerton Hospital
  • London United Kingdom

View trial on ClinicalTrials.gov


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Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Men Managed With Active Surveillance for Prostate Cancer


Condition: Prostate Cancer

Intervention:

  • Dietary Supplement: Vitamin D
  • Dietary Supplement: Omega-3
  • Dietary Supplement: Turmeric

Purpose: The purpose of this study is to see if eating vitamin D, omega 3 and turmeric (curcumin) slows the growth of prostate cancer in men on active surveillance.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03290417

Sponsor: Case Comprehensive Cancer Center

Primary Outcome Measures:

  • Measure: gene expression of very low and low risk prostate cancer patients on Active Surveillance
  • Time Frame: Up to 6 months
  • Safety Issue:
  • Measure: gene expression of very low and low risk prostate cancer patients on Active Surveillance
  • Time Frame: Up to 12 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Active Surveillance Failure
  • Time Frame: Up to 12 months
  • Safety Issue:
  • Measure: Time to Active Surveillance Failure
  • Time Frame: Up to 12 months
  • Safety Issue:

Estimated Enrollment: 75

Study Start Date: September 7, 2017

Eligibility:

  • Age: minimum N/A maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Subjects must have the diagnosis of prostate cancer and be on active surveillance. For the purpose of this study, Active surveillance implies prostate-specific antigen (PSA)<10 ng/mL, biopsy Gleason sum
  • Subjects must be followed at the Cleveland Clinic for active surveillance.
  • Subjects must be willing to adhere to the dietary modification outlined in the protocol.
  • Subjects must be willing to have prostate biopsies at the baseline, and six months after enrollment into the protocol
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Subjects receiving any treatment other than AS for prostate cancer.
  • Subjects not followed by the Cleveland Clinic.
  • Subjects unable to adhere to the dietary modification outlined in the protocol.

Contact:

  • David Levy, MD
  • 216-990-8011

Location:

  • Cleveland Clinic, Case Comprehensive Cancer Center
  • Cleveland Ohio 44195 United States

View trial on ClinicalTrials.gov


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A Phase 2 Study of Apalutamide in Active Surveillance Patients


Condition: Stage II Prostate Adenocarcinoma AJCC v7

Intervention:

  • Drug: Apalutamide
  • Other: Laboratory Biomarker Analysis
  • Other: Quality-of-Life Assessment

Purpose: This phase II trial studies how well apalutamide works in treating patients with prostate cancer who are in active surveillance. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02721979

Sponsor: University of Washington

Primary Outcome Measures:

  • Measure: Negative (i.e. no residual carcinoma) site directed and systematic prostate biopsy rate
  • Time Frame: At 90 days
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Alteration in MYC/chromosome 8q24 via fluorescence in situ hybridization
  • Time Frame: Baseline to up to 91 days
  • Safety Issue:
  • Measure: Change in quality of life as assessed using the Functional Assessment of Cancer Therapy-Prostate surveys
  • Time Frame: Baseline to up to 730 days
  • Safety Issue:
  • Measure: Change in quality of life as assessed using the Short Form-36 survey
  • Time Frame: Baseline to up to 730 days
  • Safety Issue:
  • Measure: Change in radiographic disappearance of magnetic resonance imaging detectable prostate cancer
  • Time Frame: Baseline to up to 90 days
  • Safety Issue:
  • Measure: Incidence of adverse events
  • Time Frame: Up to 730 days
  • Safety Issue:
  • Measure: Local treatment free survival
  • Time Frame: Up to 730 days
  • Safety Issue:
  • Measure: Percent of men undergoing of local treatment
  • Time Frame: At 2 years
  • Safety Issue:
  • Measure: Percentage of patients exiting active surveillance due to pathologic reclassification
  • Time Frame: At 2 years
  • Safety Issue:
  • Measure: Percentage of patients exiting active surveillance for any reason
  • Time Frame: At 2 years
  • Safety Issue:
  • Measure: Phosphatase and tensin homolog (PTEN) fluorescence in situ hybridization
  • Time Frame: Baseline to up to 91 days
  • Safety Issue:
  • Measure: Prostate-specific antigen progression free survival as defined by the Prostate Cancer Working Group 2 criteria
  • Time Frame: At 2 years
  • Safety Issue:
  • Measure: Prostate-specific antigen progression rate as defined by the Prostate Cancer Working Group 2 criteria (i.e. confirmed rising prostate-specific antigen >= 2 ng/mL at least one week apart)
  • Time Frame: At 2 years
  • Safety Issue:
  • Measure: PTEN immunohistochemistry
  • Time Frame: Baseline to up to 91 days
  • Safety Issue:
  • Measure: Severity of adverse events
  • Time Frame: Up to 730 days
  • Safety Issue:
  • Measure: Tumor messenger ribonucleic acid expression profiling/risk classification (e.g. Decipher or ribonucleic acid-seq)
  • Time Frame: Baseline to up to 91 days
  • Safety Issue:

Estimated Enrollment: 33

Study Start Date: November 2, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: Male

Inclusion Criteria:

  • Have signed an informed consent document
  • Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
  • Written authorization for use and release of health and research study information has been obtained
  • Life expectancy >= 10 years (as determined by the treating physician)
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  • Histologically confirmed adenocarcinoma of the prostate as documented by a minimum 12 core prostate biopsy completed within 1-year of enrollment (note: most recent prostate biopsy must have demonstrated prostatic adenocarcinoma)
  • Favorable risk prostate cancer as defined by:
  • Very low-risk:
  • Clinical stage T1c disease
  • PSA density (PSAD) < 0.15 ng/mL
  • Gleason score 6
  • =< 2 core biopsies with =< 50% involvement of any biopsy core with cancer, or unilateral disease =< 2 core biopsies with any percentage involvement OR
  • Low risk:
  • Clinical stage =< T2a
  • PSA < 10 ng/mL
  • Gleason score 6 OR
  • Low-intermediate risk:
  • Clinical stage T1c
  • PSA < 10 ng/ml
  • Gleason 3+4 present in =< 50% of one core/site as detected by systematic biopsy or MRI/transrectal ultrasound (TRUS) fusion guided biopsy
  • Gleason 6 disease in all other cores (maximum of 2 cores with =< 50% involvement of any core, or if unilateral disease, any percentage involvement)
  • Willing and qualified for active surveillance at Johns Hopkins or the University of Washington
  • Serum testosterone >= 150 ng/dL
  • Able to swallow the study drugs whole as a tablet
  • Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
  • Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization
  • Serum albumin >= 3.0 g/dL
  • Glomerular filtration rate (GFR) >= 45 mL/min
  • Serum potassium >= 3.5 mmol/L
  • Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (note: in subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 × ULN
  • Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
  • Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug

Exclusion Criteria:

  • Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)
  • Prior use of ARN-509 (apalutamide)
  • Have known allergies, hypersensitivity, or intolerance to ARN-509 (apalutamide) or its excipients
  • Prior or ongoing systemic therapy for prostate cancer including, but not limited to:
  • Hormonal therapy (e.g. leuprolide, goserelin, triptorelin)
  • Cytochrome P450 (CYP)-17 inhibitors (e.g. abiraterone, ketoconazole)
  • Antiandrogens (e.g. bicalutamide, nilutamide)
  • Second generation antiandrogens (e.g. enzalutamide)
  • Immunotherapy (e.g. sipuleucel-T, ipilimumab)
  • Chemotherapy (e.g. docetaxel, cabazitaxel)
  • Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
  • History of any of the following:
  • Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
  • Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
  • Any condition that in the opinion of the investigator, would preclude participation in this study
  • Current evidence of any of the following:
  • Uncontrolled hypertension
  • Gastrointestinal disorder affecting absorption
  • Active infection (e.g. human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
  • Any condition that in the opinion of the investigator, would preclude participation in this study
  • The use of drugs known to lower the seizure threshold, including: atypical antipsychotics (e.g. clozapine, olanzapine, risperidone, ziprasidone), bupropion, lithium, meperidine, pethidine, phenothiazine antipsychotics (e.g. chlorpromazine, mesoridazine, thioridazine), and tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
  • The use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors, including: itraconazole, clarithromycin, erythromycin, diltiazem, verapamil, delavirdine, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice (or grapefruits)
  • Note: If a patient is on a strong CYP3A4 inhibitor, they can be reconsidered for enrollment if they can safely stop said medication; a two week or 5 half-lives, whichever is longer, washout will be required prior to enrolling on study; subject may not resume medication while receiving apalutamide
  • Strong CYP3A4 inducers, including: phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, efavirenz, tipranavir, St. John's wort
  • Note: If a patient is on a strong CYP3A4 inhibitor, they can be reconsidered for enrollment if they can safely stop said medication; a two week or 5 half-lives, whichever is longer, washout will be required prior to enrolling on study; subject may not resume medication while receiving apalutamide
  • Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule

Locations:

  • Johns Hopkins University/Sidney Kimmel Cancer Center
  • Baltimore Maryland 21287 United States
  • Fred Hutch/University of Washington Cancer Consortium
  • Seattle Washington 98109 United States

View trial on ClinicalTrials.gov


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