Participant flow

177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer · Source last updated 2026-08-26

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

groups

1. description

   Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.

   id

   FG000

   title

   177Lu-PSMA-617 (AAA617)

2. description

   For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.

   id

   FG001

   title

   Androgen Receptor-directed Therapy (ARDT)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         5

      type

      Subject decision

   2. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         12

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         32

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         54

      2. group Id

         FG001

         num Subjects

         173

      type

      Progressive disease

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Treated but excluded from FAS because of protocol deviation

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         9

      type

      Treatment ongoing at the data cut-off date of 1-Jan-2025

   9. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         2

      type

      Participants not treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         235

      2. group Id

         FG001

         num Subjects

         234

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         228

      2. group Id

         FG001

         num Subjects

         232

      type

      Participants Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         234

      2. group Id

         FG001

         num Subjects

         234

      comment

      The Full Analysis Set (FAS) comprised all participants to whom study treatment was assigned by randomization.

      type

      Full Analysis Set (FAS)

   4. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      comment

      Excluded from Full Analysis Set \& Safety Set due to protocol deviation (informed consent not obtained per due process)

      type

      Excluded From FAS

   5. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         2

      type

      Participants Not Treated

   6. achievements

      1. group Id

         FG000

         num Subjects

         96

      2. group Id

         FG001

         num Subjects

         223

      type

      Discontinued Study Treatment

   7. achievements

      1. group Id

         FG000

         num Subjects

         227

      2. group Id

         FG001

         num Subjects

         232

      comment

      The Safety Set included all participants who received at least one dose of study treatment (i.e., at least one dose of (AAA617 or ARPIs) during the randomized part of the protocol.

      type

      Safety Set

   8. achievements

      1. group Id

         FG000

         num Subjects

         131

      2. group Id

         FG001

         num Subjects

         0

      comment

      Completed = Completed treatment

      type

      COMPLETED

   9. achievements

      1. group Id

         FG000

         num Subjects

         104

      2. group Id

         FG001

         num Subjects

         234

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

During screening, all participants underwent imaging with the investigational product gallium (68Ga) gozetotide for the purpose of determining eligibility.

recruitment Details

Informed consent was obtained from all eligible participants who were randomized via Interactive Response Technology (IRT) to one of the arms in a 1:1 ratio: 177Lu-PSMA-617 or Androgen receptor-directed therapy (ARDT).

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Preserved source evidence · Not medical advice