Table 1.
Summary of the various molecules currently associated with post-prostatectomy radiotherapy, either in adjuvant situations on anatomopathological criteria (2 studies) or – in most cases – depending on the elevation in PSA after prostatectomy.
| Systemic treatment | Study ID | Population | Study Arm | Radiotherapy | Outcomes Results | Recruitment | Results |
|---|---|---|---|---|---|---|---|
| mTOR inhibitor |
NCT01548807 Phase I (5-7,5-10mg) |
Biochemical recurrence after prostatectomy | Rapamycin + RT | 66,6Gy/37F IMRT Daily CBCT | 10 mg is safe | Completed | Published (31) |
| Abirateron acetate (AA) | NCT01780220 Phase I,II(CARLHA) | Biochemical recurrence after partial response | A: AA-Prednisolone-ADT-RTB: AA-Prednisolone-RT | Prostate bed radiotherapy IMRT 66Gy/33F | B: not recommended Dose: 750 mg | Completed | Published (19) |
| Enzalutamide | NCT02057939 Phase II( STREAM) | Biochemical relapse after partial response | Enza-ADT-RT | 66Gy/33F | 2-year PFS: 65% | Completed | Published (20) |
| Enzalutamide | NCT02203695 Phase II (SALV-ENZA) | Biochemical relapse after partial response | A: RT-PlaceboB: RT-Enzalutamide | 66,6-70,2 Gy (daily placebo/enzlutamide and 2 months after and before |
FFPP (freedom from PSA progression) | Not recruiting | Not published |
| Enzalutamide |
NCT03809000 Phase II (STEEL) |
Biochemical relapse after prostatectomy | A: Enza-ADT-RTB: ADT-RT | 66-70.2 Gy | PFS | Recruiting | Not published |
| Apalutamide | NCT03311555 Phase II(STARTAR) | Biochemical complete response after radical prostatectomy | Apalutamide-ADT-RT + adjuvant cocetaxel | 66-74 Gy in 1,8-2 Gy daily fractions over a total of 6-8 weeks | PFS | Not recruiting | Not published |
| Apalutamide |
NCT04181203 Phase III (CARLHA-2) |
High-risk postprostatectomy biochemically relapsed prostate cancer patients | A: apalutamide-RT-ADTB: RT-ADT | Prostate bed: 66Gy/33FPelvic node: 56,1Gy/33FSIB 69,3/33F to local relapse (TEP/IRM) | PFS | Recruiting | Not published |
| Apalutamide | NCT03899077 Phase II (SAVE) | Biochemical progression after radical prostatectomy | A: ADT-RTB: ADT-RT-Apalutamide | NA | EPIC-26 sexual domain score | Recruiting | Not published |
| Apalutamide | NCT03371719NRG-GU006 Phase II (BALANCE) | Biochemical progression after radical prostatectomy | A: RT-placeboB: RT-apalutamide | NA | bPFS2nd: stratification by PAM50 gene expression | Not recruiting | Not published |
| AA+Apalutamide | NCT03141671 Phase II(FORMULA-509) | Rising PSA after prostatectomy with adverse features | A: ADT-AA-apalutamide-RTB: ADT-RT | NA | PFS | Not recruiting | Not published |
| Docetaxel Sunitinib | NCT00734851 Phase II | Rising PSA after prostatectomy | 4 cycles D1-D21:Docetaxel-Sunitinib D1-D14 | Radiotherapy after docetaxel sunitinib66Gy/33F | PFS | Completed | Published (32) |
| Satraplatin |
NCT00480623 Phase I |
Rising PSA after prostatectomy | Satraplatin+RT concomittant | NA | DMTDLT | Completed | Not published |
| Taxotere | NCT00480857Phase II | Rising PSA after prostatectomy | Docetaxel 20mg/m2 weekly during RT | 64,9-70.3 to tumor bed | No increase in toxicityNo clinical benefit | Completed | Published (33) |
| Cabazitaxel | NCT01650285 | Pathological determined stage 3 and/or PSA rising | CabazitaxelDay 1,22,43 | 64,8 Gy IMRTAdjuvant | DMT | Completed | Not published |
| Ixabepilone | NCT01079793 | Pathological determined stage 3 | Ixabepilone IB D1-D8D1=D21 | IMRTAdjuvant | DMT | Closed | Closed |
| Metformin | NCT02945813 Phase II PROMET | Rising PSA after prostatectomy | A: Metformin 850mg/12h + RTB: RT | 70Gy/35F | TTP (time to progression) | Completed | Not published |
NA, not assessable.