Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06136650




Registration number
NCT06136650
Ethics application status
Date submitted
13/11/2023
Date registered
18/11/2023
Date last updated
20/11/2024

Titles & IDs
Public title
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
Scientific title
A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA)
Secondary ID [1] 0 0
MK-5684-004
Secondary ID [2] 0 0
5684-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-resistant Prostate Cancer (mCRPC) 0 0
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Opevesostat
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Fludrocortisone acetate
Treatment: Drugs - Hydrocortisone
Treatment: Drugs - Abiraterone acetate
Treatment: Drugs - Prednisone acetate
Treatment: Drugs - Enzalutamide

Experimental: hormone replacement therapy (HRT)+ opevesostat - Participants receive opevesostat 5 mg by oral tablets twice daily (BID) plus dexamethasone 1.5 mg by oral tablets and fludrocortisone acetate 0.1 mg oral tablet once daily (QD) continuously until disease progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) will also be provided to participants for use as rescue medication.

Active comparator: Alternative next generation hormonal agent (NHA) - Participants receive Abiraterone 1000 mg QD by oral tablets plus Prednisone 5 mg BID by oral tablets or Enzalutamide 160 mg QD by oral tablets until disease progression.


Treatment: Drugs: Opevesostat
Administered orally

Treatment: Drugs: Dexamethasone
Administered orally

Treatment: Drugs: Fludrocortisone acetate
Administered orally

Treatment: Drugs: Hydrocortisone
Administered orally or IM as a rescue drug

Treatment: Drugs: Abiraterone acetate
Administered orally

Treatment: Drugs: Prednisone acetate
Administered orally

Treatment: Drugs: Enzalutamide
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Progression-free Survival (rPFS)
Timepoint [1] 0 0
Up to approximately 82 months
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 82 months
Secondary outcome [1] 0 0
Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
Timepoint [1] 0 0
Up to approximately 82 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to approximately 82 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to approximately 82 months
Secondary outcome [4] 0 0
Time to Pain Progression (TTPP)
Timepoint [4] 0 0
Up to approximately 82 months
Secondary outcome [5] 0 0
Prostrate-specific Antigen (PSA) Response Rate
Timepoint [5] 0 0
Up to approximately 82 months
Secondary outcome [6] 0 0
Time to Prostate-specific Antigen (PSA) Progression
Timepoint [6] 0 0
Up to approximately 82 months
Secondary outcome [7] 0 0
Time to first symptomatic skeletal-related event (TSSRE)
Timepoint [7] 0 0
Up to approximately 82 months
Secondary outcome [8] 0 0
Number of Participants Who Experience an Adverse Event (AE)
Timepoint [8] 0 0
Up to approximately 82 months
Secondary outcome [9] 0 0
Number of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [9] 0 0
Up to approximately 82 months
Secondary outcome [10] 0 0
Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score
Timepoint [10] 0 0
Baseline, and up to approximately 82 months
Secondary outcome [11] 0 0
Time to Deterioration (TTD) in FACT-G Total Score
Timepoint [11] 0 0
Up to approximately 82 months
Secondary outcome [12] 0 0
Overall Improvement in FACT-G Total Score
Timepoint [12] 0 0
Up to approximately 82 months

Eligibility
Key inclusion criteria
The main inclusion criteria include but are not limited to the following:

* Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
* Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography scan (CT)/magnetic resonance imaging (MRI)
* Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening
* Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) metastatic hormone sensitive prostate cancer (mHSPC) or non metastatic hormone sensitive prostate cancer (nmHSPC), for at least 8 weeks (at least 14 weeks for participants with bone progression) Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than six cycles of docetaxel and had no radiographic disease progression while receiving docetaxel
* Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
* Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
* Has had prior treatment with Poly polymerase inhibitors (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
* Has adequate organ function
* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening
* Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to =Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have =Grade 2 neuropathy are eligible
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The main exclusion criteria include but are not limited to the following:

* Has presence of gastrointestinal condition
* Is unable to swallow capsules/tablets
* Has history of pituitary dysfunction
* Has poorly controlled diabetes mellitus
* Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
* Has clinically significant abnormal serum potassium or sodium level
* Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) <110 mmHg, or Uncontrolled hypertension: systolic BP >160mmHg or diastolic blood BP >90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy
* History or family history of long QTc syndrome
* Has a history of seizure(s) within 6 months prior to signing the informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment
* Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
* Has received a taxane-based chemotherapy and or NHA for metastatic castration-resistant prostate cancer (mCRPC)
* Has not adequately recovered from major surgery or have ongoing surgical complications
* Has received prior treatment with radium for prostate cancer
* Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures
* Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
* Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids
* Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
* Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention
* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat.
* Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention
* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed
* Active infection requiring systemic therapy
* Has concurrent active Hepatitis B virus and Hepatitis C virus infection

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/12/2030
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Macquarie University-MQ Health Clinical Trials Unit ( Site 0214) - Macquarie University
Recruitment hospital [2] 0 0
Westmead Hospital-Department of Medical Oncology ( Site 0212) - Westmead
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si - Brisbane
Recruitment hospital [4] 0 0
Monash Health ( Site 0219) - Clayton
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0210) - Melbourne
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Montana
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
Brazil
State/province [23] 0 0
Bahia
Country [24] 0 0
Brazil
State/province [24] 0 0
Ceara
Country [25] 0 0
Brazil
State/province [25] 0 0
Espirito Santo
Country [26] 0 0
Brazil
State/province [26] 0 0
Maranhao
Country [27] 0 0
Brazil
State/province [27] 0 0
Minas Gerais
Country [28] 0 0
Brazil
State/province [28] 0 0
Parana
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio Grande Do Sul
Country [30] 0 0
Brazil
State/province [30] 0 0
Sao Paulo
Country [31] 0 0
Chile
State/province [31] 0 0
Araucania
Country [32] 0 0
Chile
State/province [32] 0 0
Maule
Country [33] 0 0
Chile
State/province [33] 0 0
Region M. De Santiago
Country [34] 0 0
Chile
State/province [34] 0 0
Valparaiso
Country [35] 0 0
China
State/province [35] 0 0
Anhui
Country [36] 0 0
China
State/province [36] 0 0
Beijing
Country [37] 0 0
China
State/province [37] 0 0
Chongqing
Country [38] 0 0
China
State/province [38] 0 0
Fujian
Country [39] 0 0
China
State/province [39] 0 0
Guangdong
Country [40] 0 0
China
State/province [40] 0 0
Hubei
Country [41] 0 0
China
State/province [41] 0 0
Hunan
Country [42] 0 0
China
State/province [42] 0 0
Jiangsu
Country [43] 0 0
China
State/province [43] 0 0
Shaanxi
Country [44] 0 0
China
State/province [44] 0 0
Shandong
Country [45] 0 0
China
State/province [45] 0 0
Shanghai
Country [46] 0 0
China
State/province [46] 0 0
Sichuan
Country [47] 0 0
China
State/province [47] 0 0
Tianjin
Country [48] 0 0
China
State/province [48] 0 0
Xinjiang
Country [49] 0 0
China
State/province [49] 0 0
Yunnan
Country [50] 0 0
China
State/province [50] 0 0
Zhejiang
Country [51] 0 0
Colombia
State/province [51] 0 0
Cesar
Country [52] 0 0
Colombia
State/province [52] 0 0
Cordoba
Country [53] 0 0
Colombia
State/province [53] 0 0
Distrito Capital De Bogota
Country [54] 0 0
Colombia
State/province [54] 0 0
Santander
Country [55] 0 0
Colombia
State/province [55] 0 0
Valle Del Cauca
Country [56] 0 0
Costa Rica
State/province [56] 0 0
San Jose
Country [57] 0 0
Czechia
State/province [57] 0 0
Brno-mesto
Country [58] 0 0
Czechia
State/province [58] 0 0
Jihomoravsky Kraj
Country [59] 0 0
Czechia
State/province [59] 0 0
Liberecky Kraj
Country [60] 0 0
Czechia
State/province [60] 0 0
Praha 5
Country [61] 0 0
Czechia
State/province [61] 0 0
Olomouc
Country [62] 0 0
Czechia
State/province [62] 0 0
Praha 2
Country [63] 0 0
Estonia
State/province [63] 0 0
Harjumaa
Country [64] 0 0
Estonia
State/province [64] 0 0
Tartumaa
Country [65] 0 0
France
State/province [65] 0 0
Alsace
Country [66] 0 0
France
State/province [66] 0 0
Aquitaine
Country [67] 0 0
France
State/province [67] 0 0
Finistere
Country [68] 0 0
France
State/province [68] 0 0
Haute-Garonne
Country [69] 0 0
France
State/province [69] 0 0
Hauts-de-Seine
Country [70] 0 0
France
State/province [70] 0 0
Ile-de-France
Country [71] 0 0
France
State/province [71] 0 0
Puy-de-Dome
Country [72] 0 0
France
State/province [72] 0 0
Rhone-Alpes
Country [73] 0 0
France
State/province [73] 0 0
Vaucluse
Country [74] 0 0
Germany
State/province [74] 0 0
Baden-Wurttemberg
Country [75] 0 0
Germany
State/province [75] 0 0
Bayern
Country [76] 0 0
Germany
State/province [76] 0 0
Hessen
Country [77] 0 0
Germany
State/province [77] 0 0
Niedersachsen
Country [78] 0 0
Germany
State/province [78] 0 0
Nordrhein-Westfalen
Country [79] 0 0
Germany
State/province [79] 0 0
Sachsen
Country [80] 0 0
Germany
State/province [80] 0 0
Berlin
Country [81] 0 0
Greece
State/province [81] 0 0
Achaia
Country [82] 0 0
Greece
State/province [82] 0 0
Attiki
Country [83] 0 0
Guatemala
State/province [83] 0 0
Ciudad de Guatemala
Country [84] 0 0
Guatemala
State/province [84] 0 0
Guatemala
Country [85] 0 0
Hong Kong
State/province [85] 0 0
Central
Country [86] 0 0
Hong Kong
State/province [86] 0 0
Hksar
Country [87] 0 0
Hungary
State/province [87] 0 0
Borsod-Abauj-Zemplen
Country [88] 0 0
Hungary
State/province [88] 0 0
Nograd
Country [89] 0 0
Hungary
State/province [89] 0 0
Pest
Country [90] 0 0
Hungary
State/province [90] 0 0
Debrecen
Country [91] 0 0
Ireland
State/province [91] 0 0
Dublin
Country [92] 0 0
Israel
State/province [92] 0 0
Afula
Country [93] 0 0
Israel
State/province [93] 0 0
Haifa
Country [94] 0 0
Israel
State/province [94] 0 0
Jerusalem
Country [95] 0 0
Israel
State/province [95] 0 0
Kfar Saba
Country [96] 0 0
Israel
State/province [96] 0 0
Petah Tikva
Country [97] 0 0
Israel
State/province [97] 0 0
Ramat Gan
Country [98] 0 0
Israel
State/province [98] 0 0
Tel Aviv
Country [99] 0 0
Italy
State/province [99] 0 0
Emilia-Romagna
Country [100] 0 0
Italy
State/province [100] 0 0
Lombardia
Country [101] 0 0
Italy
State/province [101] 0 0
Catania
Country [102] 0 0
Italy
State/province [102] 0 0
Foggia
Country [103] 0 0
Italy
State/province [103] 0 0
Milano
Country [104] 0 0
Italy
State/province [104] 0 0
Terni
Country [105] 0 0
Japan
State/province [105] 0 0
Chiba
Country [106] 0 0
Japan
State/province [106] 0 0
Fukui
Country [107] 0 0
Japan
State/province [107] 0 0
Fukuoka
Country [108] 0 0
Japan
State/province [108] 0 0
Hokkaido
Country [109] 0 0
Japan
State/province [109] 0 0
Hyogo
Country [110] 0 0
Japan
State/province [110] 0 0
Ishikawa
Country [111] 0 0
Japan
State/province [111] 0 0
Kagawa
Country [112] 0 0
Japan
State/province [112] 0 0
Kanagawa
Country [113] 0 0
Japan
State/province [113] 0 0
Mie
Country [114] 0 0
Japan
State/province [114] 0 0
Nagasaki
Country [115] 0 0
Japan
State/province [115] 0 0
Nara
Country [116] 0 0
Japan
State/province [116] 0 0
Okinawa
Country [117] 0 0
Japan
State/province [117] 0 0
Osaka
Country [118] 0 0
Japan
State/province [118] 0 0
Saga
Country [119] 0 0
Japan
State/province [119] 0 0
Tokyo
Country [120] 0 0
Japan
State/province [120] 0 0
Akita
Country [121] 0 0
Japan
State/province [121] 0 0
Gifu
Country [122] 0 0
Japan
State/province [122] 0 0
Hiroshima
Country [123] 0 0
Japan
State/province [123] 0 0
Kagoshima
Country [124] 0 0
Japan
State/province [124] 0 0
Kumamoto
Country [125] 0 0
Japan
State/province [125] 0 0
Miyazaki
Country [126] 0 0
Japan
State/province [126] 0 0
Nagano
Country [127] 0 0
Japan
State/province [127] 0 0
Oita
Country [128] 0 0
Korea, Republic of
State/province [128] 0 0
Kyonggi-do
Country [129] 0 0
Korea, Republic of
State/province [129] 0 0
Taegu-Kwangyokshi
Country [130] 0 0
Korea, Republic of
State/province [130] 0 0
Seoul
Country [131] 0 0
Latvia
State/province [131] 0 0
Liepaja
Country [132] 0 0
Latvia
State/province [132] 0 0
Riga
Country [133] 0 0
Lithuania
State/province [133] 0 0
Kauno Apskritis
Country [134] 0 0
Lithuania
State/province [134] 0 0
Vilniaus Miestas
Country [135] 0 0
Malaysia
State/province [135] 0 0
Johor
Country [136] 0 0
Malaysia
State/province [136] 0 0
Kuala Lumpur
Country [137] 0 0
Malaysia
State/province [137] 0 0
Sarawak
Country [138] 0 0
Malaysia
State/province [138] 0 0
Wilayah Persekutuan Putrajaya
Country [139] 0 0
Mexico
State/province [139] 0 0
Nuevo Leon
Country [140] 0 0
Mexico
State/province [140] 0 0
Oaxaca
Country [141] 0 0
New Zealand
State/province [141] 0 0
Otago
Country [142] 0 0
New Zealand
State/province [142] 0 0
Auckland
Country [143] 0 0
Peru
State/province [143] 0 0
Lima
Country [144] 0 0
Portugal
State/province [144] 0 0
Lisboa
Country [145] 0 0
Portugal
State/province [145] 0 0
Porto
Country [146] 0 0
Portugal
State/province [146] 0 0
Braga
Country [147] 0 0
Puerto Rico
State/province [147] 0 0
Ponce
Country [148] 0 0
Puerto Rico
State/province [148] 0 0
San Juan
Country [149] 0 0
Romania
State/province [149] 0 0
Bucuresti
Country [150] 0 0
Romania
State/province [150] 0 0
Cluj
Country [151] 0 0
Romania
State/province [151] 0 0
Dolj
Country [152] 0 0
Singapore
State/province [152] 0 0
Central Singapore
Country [153] 0 0
Slovakia
State/province [153] 0 0
Nitriansky Kraj
Country [154] 0 0
Slovakia
State/province [154] 0 0
Trenciansky Kraj
Country [155] 0 0
South Africa
State/province [155] 0 0
Eastern Cape
Country [156] 0 0
South Africa
State/province [156] 0 0
Gauteng
Country [157] 0 0
South Africa
State/province [157] 0 0
Western Cape
Country [158] 0 0
Spain
State/province [158] 0 0
Barcelona
Country [159] 0 0
Spain
State/province [159] 0 0
Cataluna
Country [160] 0 0
Spain
State/province [160] 0 0
Gerona
Country [161] 0 0
Spain
State/province [161] 0 0
Las Palmas
Country [162] 0 0
Spain
State/province [162] 0 0
Madrid
Country [163] 0 0
Spain
State/province [163] 0 0
Burgos
Country [164] 0 0
Spain
State/province [164] 0 0
Malaga
Country [165] 0 0
Sweden
State/province [165] 0 0
Stockholms Lan
Country [166] 0 0
Sweden
State/province [166] 0 0
Uppsala Lan
Country [167] 0 0
Taiwan
State/province [167] 0 0
Tainan
Country [168] 0 0
Taiwan
State/province [168] 0 0
Kaohsiung
Country [169] 0 0
Taiwan
State/province [169] 0 0
Taichung
Country [170] 0 0
Taiwan
State/province [170] 0 0
Taipei
Country [171] 0 0
Taiwan
State/province [171] 0 0
Taoyuan
Country [172] 0 0
Turkey
State/province [172] 0 0
Adana
Country [173] 0 0
Turkey
State/province [173] 0 0
Ankara
Country [174] 0 0
Turkey
State/province [174] 0 0
Istanbul
Country [175] 0 0
Turkey
State/province [175] 0 0
Izmir
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Cambridgeshire
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Derbyshire
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Devon
Country [179] 0 0
United Kingdom
State/province [179] 0 0
England
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Glasgow City
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Hammersmith And Fulham
Country [182] 0 0
United Kingdom
State/province [182] 0 0
London, City Of
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Oxfordshire
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Windsor And Maidenhead
Country [185] 0 0
United Kingdom
State/province [185] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Orion Corporation, Orion Pharma
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.
Trial website
https://clinicaltrials.gov/study/NCT06136650
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06136650