Table 1.
Current clinical trials involving immunotherapy in combination with ADT and RT in PCa (completed and in-progress).
| ClinicalTrials.Gov Identifier | Phase | Immunotherapy | ADT | RT | Timing |
|---|---|---|---|---|---|
| NCT02107430 [169] | 2 | DCVAC/PCa | LHRH-a | Standard EBRT | DCVAC/PCa after RP and RT; Neo-adjuvant LHRH-a |
| PMC4241355 [146] | 0 | Dendritic Cell Vaccine | GnRH-a and Bicalutamide | EBRT (45 Gy in 25 fractions) and BT | ADT start 30–44 days before RT; intraprostatic DC injection after fractions 5, 15, and 25 |
| NCT00323882 [170] | 1, 2 | Ipilimumab | Prior disease progression w/ADT | EBRT (8 Gy/lesion) | Prior ADT; Single dose RT to bone metastases <2 days before Ipilimumab |
| NCT00861614 [171] | 3 | Ipilimumab | Prior ADT | EBRT (8 Gy/lesion) | Prior ADT; Single dose RT to bone metastases <2 days before Ipilimumab or placebo |
| NCT01777802 [172] | 0 | Monitor Timing for Immune Modulation | Prior ADT | SBRT | Monitor for immune changes after RT |
| NCT01436968 [173] | 3 | ProstAtak™(AdV-tk) | 6 months ADT | Standard EBRT | Two doses of ProstAtak™(AdV-tk) or placebo before RT, 3ird dose during RT; short term (6mo) ADT optional |
| NCT00005916 [174] | 2 | rV-PSA, rV-B7.1, GM-CSF and IL-2 | Ongoing ADT allowed | Standard EBRT +/− BT | GM-CSF on days 1-4, rV-PSA/rV-B7.1 on day 2, low dose IL-2 on days 8–21 (repeat cycle every 28 days); RT after 3rd cycle |
| NCT00005916 [174] | 2 | rV-PSA, rV-B7.1, GM-CSF and IL-2 | Ongoing ADT allowed | Standard EBRT +/− BT | GM-CSF on days 1–4, rV-PSA/rV-B7.1 on day 2, IL-2 on days 8–12 (repeat cycle every 28 days); RT between 4th and 6th cycle |
| NCT00450619 [175] | 2 | PROSTVAC-TRICOM | Ongoing ADT | 153Sm-EDTMP | PROSTVAC-TRICOM on day 1, 15, 29, and every 28 days thereafter; 153Sm-EDTMP starting on day 8 and every 12 weeks thereafter |
| NCT01807065 [142] | 2 | Sipuleucel-T | Disease progression w/ADT | EBRT | RT in weeks 1–2 to a single metastasis, Sipuleucel-T on days 22, 36, and 50 |
| NCT01818986 [143] | 2 | Sipuleucel-T | Ongoing ADT | SABR | Not specified |
| NCT02463799 [144] | 2 | Sipuleucel-T | Disease progression w/ADT | 223Ra | 223Ra every 4 weeks (6 cycles); Sipuleucel-T every 2 weeks starting on week 6 (3 cycles) |
| NCT02232230 [145] | 2 | Sipuleucel-T | Prior ADT | EBRT | RT to metastases 28 days prior to Sipuleucel-T |
| NCT01496131 [176] | 2 | Tecemotide (L-BLP25) | Goserelin | EBRT (54–72 Gy in 30–40 fractions) | Tecemotide and ADT start 2–3 months before starting RT |
Abbreviations: luteinizing-hormone-releasing hormone analogues (LHRH-a); gonadotropin-releasing hormone agonist (GnRH-a); samarium-153-ethylenediamine tetramethylene phosphonic acid (153Sm-EDTMP); radium-223 (223Ra); recombinant Vaccinia (rV); prostate-specific antigen (PSA); stereotactic ablative radiotherapy (SABR); Interleukin-2 (IL-2); granulocyte macrophage colony stimulating factor (GM-CSF); external beam radiation therapy (EBRT); brachytherapy (BT); stereotactic body radiation therapy (SBRT); radical prostatectomy (RP).