Table 6.
Characteristics of Current Clinical Trials at Phases II and III for Prostate Cancer, 2022 (as of 5 December 2022).
| No. | NCT Number | Status | Conditions | Interventions | Key Outcome Measures |
|---|---|---|---|---|---|
| 1 | NCT03207867 | Active, not recruiting | mCRPC | NIR178; PDR001 | ORR; DCR; DOR; OS; PFS; safety and tolerability; pharmacokinetics |
| 2 | NCT03866382 | Recruiting | Metastatic Prostate Small-Cell Neuroendocrine Carcinoma; Stage IV, IVA, IVB Prostate Cancer AJCC v8 | Cabozantinib S-malate; Ipilimumab; Nivolumab | ORR; DOR; PFS; OS; CBR; adverse events |
| 3 | NCT02768363 | Active, not recruiting | Prostate Cancer | Aglatimagene besadenovec; valacyclovir | PFS; PSA; time to radical treatment; adverse events |
| 4 | NCT04104893 | Recruiting | mCRPC | Pembrolizumab | PSA; ORR; time to progression of disease; OS; adverse events (safety and tolerability) |
| 5 | NCT03651271 | Active, not recruiting | Advanced Metastatic Cancer; Advanced Prostate Cancer | Nivolumab Monotherapy; Nivolumab + Ipilimumab | CBR; CD8 cells in biopsies; safety; ORR |
| 6 | NCT03570619 | Active, not recruiting | mCRPC; Metastatic Cancer; Solid Tumor | Nivolumab; Ipilimumab | Patient response with CDK12 loss of function to treatment; PFS; TTP; OS; PSA |
| 7 | NCT02703623 | Active, not recruiting | CRPC; Metastatic PC; PSA Progression; Stage IV Prostate Adenocarcinoma AJCC v7 | Abiraterone Acetate; Apalutamide; Cabazitaxel; Carboplatin; Ipilimumab; Prednisone | OS; adverse events; androgen receptor response markers signature; TTF |
| 8 | NCT04009967 | Recruiting | Prostate Cancer | Pembrolizumab | Tumor response rate; Immune parameters; PSA; correlation of dMMR/MSI-H with pembrolizumab response |
| 9 | NCT03338790 | Active, not recruiting | Prostate Cancer | Nivolumab; docetaxel; enzalutamide; rucaparib; prednisone | ORR; PSA; PFS; time to response; DOR; adverse events; deaths; laboratory abnormalities |
| 10 | NCT03821246 | Recruiting | Prostate Adenocarcinoma; Localized Prostate Cancer | Atezolizumab; Tocilizumab; Etrumadenant | Positive response; adverse events; pCR; MRD; PSA response |
| 11 | NCT05177770 | Recruiting | mCRPC | SRF617; Etrumadenant; Zimberelimab | PSA; adverse events; ORR; DOR; DCR; pharmacokinetics; SSEs |
| 12 | NCT03315871 | Recruiting | Prostate Cancer | PROSTVAC-V; PROSTVAC-F; MSB0011359C (M7824); CV301 | PSA; adverse events |
| 13 | NCT02020070 | Active, not recruiting | Metastatic Castration-Sensitive Prostate Cancer | Degarelix; Ipilimumab; Radical Prostatectomy | PSA; PFS; OS; toxicity |
| 14 | NCT03385655 | Recruiting | Prostate Cancer | Adavosertib; Savolitinib; Darolutamide; CFI-400945; Ipatasertib; Durvalumab and Tremelimumab; Carboplatin | PSA decline of 50%; PSA progression; objective response; adverse events; PFS; OS |
| 15 | NCT03764540 | Recruiting | Metastatic Prostate Cancer | Cabazitaxel plus prednisone; Docetaxel plus prednisone | PSA response rate; PFS; OS; TTP; tumor response; DOR; pain response |
| 16 | NCT05502315 | Not yet recruiting | CRPC; Metastatic Cancer | Cabozantinib; Nivolumab | PFS; ORR; OS; CTC; adverse events; SSEs |
| 17 | NCT03795207 | Recruiting | Node/Bone Metastases; Prostate Cancer | SBRT + Durvalumab | PFS; ADT free survival; OS; acute toxicity; time to castration resistance |
| 18 | NCT05361798 | Recruiting | Prostate Cancer | M9241; SBRT | Safety; T cell clonality (immunologic activity); peripheral immune response |
| 19 | NCT04751929 | Recruiting | Prostate Cancer; mCRPC | Abemaciclib; Atezolizumab | PFS; ORR; DLTs; adverse events; CBR; DOR; DOT; TTP; OS |
| 20 | NCT04336943 | Recruiting | Biochemically Recurrent Prostate Carcinoma; Prostate Adenocarcinoma | Durvalumab; Olaparib | PSA; adverse events; quality of life |
| 21 | NCT03333616 | Recruiting | Non-adenocarcinoma Prostate Cancer, and various others | Ipilimumab; Nivolumab | ORR; DOR; OS; safety and tolerability; adverse events |
| 22 | NCT04717154 | Recruiting | Prostatic Neoplasms, Castration-Resistant | Ipilimumab; Nivolumab | DCR; adverse effects; ORR; PFS |
| 23 | NCT04126070 | Recruiting | Hormone-Sensitive Prostate Cancer; Prostate Adenocarcinoma; Metastasis Prostate Adenocarcinoma | ADT; Nivolumab; Docetaxel | PSA; ORR; OR; time to castration resistance/clinical progression/serologic progression; severe adverse events |
| 24 | NCT04592237 | Recruiting | Aggressive PC; CRPC; Metastatic Prostate Carcinoma; Metastatic Prostate Neuroendocrine Carcinoma; Metastatic Prostate Small-Cell Carcinoma; Stage IV Prostate Cancer AJCC v8 | Cabazitaxel; Carboplatin; Cetrelimab; Niraparib | PFS; OS; RR; adverse events |
| 25 | NCT04090528 | Recruiting | CRPC; Metastatic Cancer; Prostate Cancer | pTVG-HP; pTVG-AR; Pembrolizumab | PFS; ORR; PSA; RR; OS; antigen-specific Th1 immune response; safety and tolerability |
| 26 | NCT04926181 | Recruiting | Small Cell Neuroendocrine Carcinoma; Prostate Cancer; Small-Cell Carcinoma | Apalutamide; Cetrelimab | Composite RR; adverse events; median PFS; PSA; OS; OSS; DOR |
| 27 | NCT05445882 | Not yet recruiting | CRPC | Bintrafusp alfa; N-803; BN-Brachyury | Clinical efficacy; DOR; safety |
| 28 | NCT05168618 | Recruiting | CRPC; Metastatic Prostate Adenocarcinoma; Stage IV, IVA, IVB Prostate Cancer AJCC v8 | Atezolizumab; Cabozantinib S-malate | DCR; PSA; PFS; OS; adverse events |
| 29 | NCT05568550 | Not yet recruiting | Prostate Cancer | Pembrolizumab; Olaparib; ADT; Radiation Therapy | Clinical RR; biochemical/metastasis-free survival; molecular alterations in homologous recombination repair genes |
| 30 | NCT03879122 | Active, not recruiting | Metastatic Hormone-sensitive Prostate Cancer | Ipilimumab 5 MG/ML; Nivolumab 10 MG/ML; Docetaxel; ADT | OS; PSA; PFS; time to CRPC; PFS; SSEs; toxicity; quality of life |
| 31 | NCT01436968 | Active, not recruiting | Prostate Cancer | Aglatimagene besadenovec + valacyclovir; Placebo + valacyclovir | DFS; OS; PSA; safety; quality of life |
| 32 | NCT03686683 | Active, not recruiting | Adenocarcinoma, Prostate | Sipuleucel-T | Efficacy in reducing histopathologic reclassification to a higher Gleason grade |
| 33 | NCT05544227 | Recruiting | mCRPC | SV-102 | Anti-tumor activity; adverse events; treatment discontinuation |
| 34 | NCT05544240 | Recruiting | mCRPC | SV-101 | Anti-tumor activity; adverse events; treatment discontinuation |
| 35 | NCT02971358 | Recruiting | Locally Advanced and Metastatic Prostate Cancer | Radical prostatectomy | Perioperative complications; time to start ADT |
Abbreviations: ADT: androgen deprivation therapy; CBR: clinical benefit rate; CRPC: castration-resistant prostate cancer; CTC: circulating tumor cells; DCR: disease control rate; DFS: disease-free survival; dMMR: deficient mismatched repair; DOR: duration of response; DOT: duration of therapy; mCRPC: metastatic castrate-resistant prostate carcinoma; MRD: minimal residual disease; MSI-H: microsatellite instability-high; ORR: overall response rate; OS: overall survival; pCR: pathological complete responses; PFS: progression-free survival; PSA: prostate-specific antigen; RR: response rate; SBRT: stereotactic body radiation therapy; SSE: symptomatic skeletal event; TTF: time to treatment failure; TTP: time to progression.