Participant flow

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer · Source last updated 2025-01-13

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

groups

1. description

   Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used

   id

   FG000

   title

   Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)

2. description

   Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator

   id

   FG001

   title

   Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone

3. description

   non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study

   id

   FG002

   title

   Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         457

      2. group Id

         FG001

         num Subjects

         201

      3. group Id

         FG002

         num Subjects

         21

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         63

      3. group Id

         FG002

         num Subjects

         3

      type

      Withdrew consent

   3. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         2

      type

      Other protocol pre-specified reasons for discontinuation

   4. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         0

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Patient non-compliance

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         551

      2. group Id

         FG001

         num Subjects

         280

      3. group Id

         FG002

         num Subjects

         30

      comment

      All randomized patients were included in the Full Analysis Set (FAS). Patients were included in the treatment arm to which they were randomized regardless of actual treatment received.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         529

      2. group Id

         FG001

         num Subjects

         205

      3. group Id

         FG002

         num Subjects

         30

      comment

      The subset of patients in the Full Analysis Set (FAS) who received at least one dose of randomized treatment.

      type

      FAS Safety Analysis Set

   3. achievements

      1. group Id

         FG000

         num Subjects

         385

      2. group Id

         FG001

         num Subjects

         196

      3. group Id

         FG002

         num Subjects

         0

      comment

      All patients randomized on or after 05-Mar-2019. Patients were included in the treatment arm to which they were randomized regardless of actual treatment received.

      type

      Progression-Free Survival (PFS) Full Analysis Set (PFS-FAS)

   4. achievements

      1. group Id

         FG000

         num Subjects

         319

      2. group Id

         FG001

         num Subjects

         120

      3. group Id

         FG002

         num Subjects

         0

      comment

      The subset of patients in the PFS-FAS with evaluable disease by RECIST at baseline. Patients were included in the treatment arm to which they were randomized.

      type

      Response Evaluable Analysis Set

   5. achievements

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         4

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         523

      2. group Id

         FG001

         num Subjects

         274

      3. group Id

         FG002

         num Subjects

         26

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

The study was conducted in 86 sites across 9 countries. Belgium (3); Canada (7); Denmark (3); France (6); Netherlands (4); Sweden (5); UK (9); US (45); Germany (4, for the sub-study only).

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Preserved source evidence · Not medical advice