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. 2023 Jun 26;15:243–259. doi: 10.2147/RRU.S385257

Table 2.

Characteristics of Main Studies of Other-Lines of mCRPC

Compound Study Study Characteristics Outcomes
PARP inhibitors Olaparib PROfound16 387 patients:

  • 245 patients cohort A (one alteration in BRCA1/2 or ATM)

  • 142 patients cohort B (another prespecified gene alteration)


Patients received Olaparib 200 mg twice daily or ARATs based on physician choice		 OS: 18.5 vs 15.1 mo (cohort A)
rPFS: 7.4 vs 3.6 mo (cohort A)
OS: 14.1 vs 11.5 mo (cohort B)
rPFS: 5.8 vs 3.5 mo (cohort A+B)
Rucaparib TRITON2 (Phase II)17 115 patients (BRCA mutated) received 600 mg twice daily ORRs: 43.5% (independent radiology review) and 50.8% (investigator assessment).
PSA response rate 54.8%
Talazoparib TALAPRO-1 (phase II)18 128 patients (HRR alteration, already treated with ARATs), received Talazoparib 1 mg daily Overall soft tissue response: 29.8%
PI3K/AKT/mTOR inhibitors Ipatasertib IPAtential150 (phase III)19 1101 patients untreated for mCRPC, with or without PTEN loss:

  • 547 intervention arm (ipatasertib 400 mg/die, abiraterone 1 g/die)

  • 554 control arm (placebo, abiraterone 1 g/die)

 PTEN loss population
rPFS: 18.5 vs 16.5 mo
Capitavasertib ProCAID (phase II)20 150 patients:

  • 75 intervention arm (capivasertib 320 mg twice daily)

  • 75 placebo arm

 OS: 31.1 vs 20.2 mo
cPFS: 7.03 6.7 mo
Theragnostic 177Lu-PSMA-617 VISION21 831 patients:

  • 551 intervention arm (177Lu-PSMA-617 7.4 GBq every 6 weeks for 4–6 cycles)

  • 280 control arm (standard care)

 OS: 15.3 vs 11.3 mo
rPFS 8.7 vs 3.4 mo
Immunotherapy Pembrolizumab KEYNOTE-199 (phase II)22 258 patients:

  • 133 patients in cohort 1 (PD-L1 positive)

  • 66 patients in cohort 2 (PD-L1 negative)

  • 59 patients in cohort 3 (predominance of bone metastases, regardless of PD-L1 expression)

 OS:
9.5 (cohort 1) vs 7.9 (cohort 2) vs 14.1 (cohort 3) mo