Table 1.
Updated clinical trials associated with the application of SERMs/SERDs, combined with other agents in treatment and prevention of PC or adverse effects followed by first-line therapy
| SERMs or SERDs | Cancer stage | Primary purpose | Primary indication /outcome |
Clincial trial phase | Clinical trial number | Combination drug/therapy | Sponsor |
| Raloxifene | Metastatic or hormone-refractory prostate cancer | Treatment | PFS, AEs, QoL assessment, survival time | I (completed) | NCT01050842 | Bicalutamide | Mayo Clinic |
| Toremifene | Stage I or stage II prostate cancer followed by radical prostatectomy | Prevention (neoadjuvant therapy) |
Percent of radical prostatectomy tissue volume | II (completed) | NCT00020735 | Surgery | University of Pittsburgh |
| Tamoxifen | Locally advanced prostate cancer | Prevention | Incidence of gynecomastia and breast pain | III (completed) | NCT00233610 | Bicalutamide | AstraZeneca |
| Zuclomiphene citrate | Advanced prostate cancer | Treatment | Change in frequency of moderate to severe hot flashes | II (completed) | NCT03646162 | ADT | Veru Inc. |
| Toremifene citrate | Prostate cancer on androgen deprivation therapy | Prevention | Percentage of subjects at 24 months with at least one new vertebral fracture | III (completed) | NCT00129142 | ADT | GTx |
| Toremifene | Prostate cancer on androgen deprivation therapy | Prevention | The efficacy of toremifene in the reduction in the risk of new bone fracture occurrences | III (withdrawn) | NCT01214291 | ADT | GTx |
| Raloxifene hydrochloride | Prostate cancer undergoing surgery | Treatment (neoadjuvant therapy) |
Collection and interrogation of prostate cancer samples | II (withdrawn) | NCT03147196 | Bicalutamide surgery |
Mayo Clinic |
| Tamoxifen | Adenocarcinoma of the prostate gland but with no evidence of distant metastasis | Treatment | The extent of gynaecomastia and breast pain by treatment group | II (completed) | NCT00637871 | Casodex | AstraZeneca |
| Toremifene | High grade prostatic intraepithelial neoplasia (PIN) | Prevention | The efficacy of toremifene in the prevention of prostate cancer | III (completed) | NCT00106691 | GTx | |
| Tamoxifen | Prostate cancer with stage T1a, T1b T2a or T2b Nx Mx | Treatment | Total prostate volume | II (unknown) | NCT00866554 | Bicalutamide, dutasteride, brachytherapy |
CHU de Quebec-Universite Laval |
| Toremifene citrate | High grade prostate intraepithelial neoplasia | Prevention (chemoprevention) |
Investigational medication that reduce high grade PIN and prevent the occurrence of prostate cancer | II (completed) | NCT00028353 | GTx | |
| Fulvestrant | Recurrent prostate cancer | Treatment | Proportion of patients who respond to treatment | II (terminated) | NCT00217464 | Roswell Park Cancer Institute | |
| Fulvestrant | Hormone refractory prostate cancer | Treatment | PSA reduction ≥50% | II (completed) | NCT00476645 | Stanford University | |
| Fulvestrant | Advanced prostate cancer | Treatment | PSA objective response rate | II (completed) | NCT00244998 | Roswell Park Cancer Institute |
AEs, adverse effects; PC, prostate cancer; PFS, progression-free survival; PSA, prostate specific antigen; Qol, quality oflife; SERDs, selective estrogen receptor degraders; SERMs, selective estrogen receptor modulators.