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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 October 2023 |
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Main ID: |
NCT02987543 |
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Date of registration:
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15/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)
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Scientific title:
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A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound) |
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Date of first enrolment:
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February 6, 2017 |
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Target sample size:
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387 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02987543 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Australia
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Austria
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Brazil
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Canada
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China
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Denmark
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France
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Germany
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Israel
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Italy
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Japan
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Korea, Republic of
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Netherlands
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Norway
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Spain
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Sweden
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Taiwan
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Johann de Bono, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Institute of Cancer Research, United Kingdom |
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Name:
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Maha Hussain, M.D., FACP, FASCO |
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Address:
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Telephone:
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Email:
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Affiliation:
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Northwestern University, United States of America |
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Key inclusion & exclusion criteria
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Inclusion criteria
1. Histologically confirmed diagnosis of prostate cancer.
2. Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
3. Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate
and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC .
4. Ongoing therapy with LHRH analog or bilateral orchiectomy.
5. Radiographic progression at study entry while on androgen deprivation therapy (or
after bilateral orchiectomy).
6. Qualifying HRR mutation in tumor tissue.
Exclusion criteria
1. Any previous treatment with PARP inhibitor, including olaparib.
2. Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy,
except if for non-prostate cancer indication and last dose > 5 years prior to
randomization.
3. Other malignancy (including MDS and MGUS) within the last 5 years except: adequately
treated non-melanoma skin cancer or other solid tumors curatively treated with no
evidence of disease for =5 years.
4. Subjects with known brain metastases.
Age minimum:
18 Years
Age maximum:
130 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Metastatic Castration-resistant Prostate Cancer
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Intervention(s)
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Drug: olaparib
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Drug: enzalutamide
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Drug: abiraterone acetate
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Primary Outcome(s)
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Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A Only
[Time Frame: Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).]
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Secondary Outcome(s)
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Time to Pain Progression - Cohort A Only
[Time Frame: Every 4 weeks from randomisation (for 7 consecutive days) throughout the study (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).]
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Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) - Cohort A Only
[Time Frame: Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).]
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Overall Survival (OS) - Cohort A Only
[Time Frame: Approximately 35 months after the first patient was randomised.]
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Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A+B
[Time Frame: Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).]
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Secondary ID(s)
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2016-000300-28
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D081DC00007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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