Participant flow

Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study) · Source last updated 2023-10-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   2x150mg film-coated tablets

   id

   FG000

   title

   Cohort A Olaparib 300mg bd

2. description

   either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)

   id

   FG001

   title

   Cohort A Investigators Choice of NHA

3. description

   2x150mg film-coated tablets

   id

   FG002

   title

   Cohort B Olaparib 300mg bd

4. description

   either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)

   id

   FG003

   title

   Cohort B Investigators Choice of NHA

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         49

      2. group Id

         FG001

         num Subjects

         21

      3. group Id

         FG002

         num Subjects

         19

      4. group Id

         FG003

         num Subjects

         12

      type

      Ongoing study at data cut off

   2. reasons

      1. group Id

         FG000

         num Subjects

         88

      2. group Id

         FG001

         num Subjects

         54

      3. group Id

         FG002

         num Subjects

         67

      4. group Id

         FG003

         num Subjects

         28

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      type

      Screen failure

   5. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         6

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Study terminated by sponsor

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Investigator decision

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      type

      Disease progression

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         162

      2. group Id

         FG001

         num Subjects

         83

      3. group Id

         FG002

         num Subjects

         94

      4. group Id

         FG003

         num Subjects

         48

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         162

      2. group Id

         FG001

         num Subjects

         83

      3. group Id

         FG002

         num Subjects

         94

      4. group Id

         FG003

         num Subjects

         48

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Subjects were divided into two cohorts based on HRR gene mutation status. Subjects with mutations in either BRCA1, BRCA2, or ATM are in Cohort A whereas subjects with mutations among 12 other genes involved in the HRR pathway (BARD1, BRIP1, CDK12, CHEK1,CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, or RAD54L) are in Cohort B.

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Preserved source evidence · Not medical advice