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 SERDsCancer stagePrimary purposePrimary indication
Clincial trial phaseClinical trial numberCombination drug/therapySponsor
RaloxifeneMetastatic or hormone-refractory prostate cancerTreatmentPFS, AEs, QoL assessment, survival timeI (completed)NCT01050842BicalutamideMayo Clinic
ToremifeneStage I or stage II prostate cancer followed by radical prostatectomyPrevention
(neoadjuvant therapy)
Percent of radical prostatectomy tissue volumeII (completed)NCT00020735SurgeryUniversity of Pittsburgh
TamoxifenLocally advanced prostate cancerPreventionIncidence of gynecomastia and breast painIII (completed)NCT00233610BicalutamideAstraZeneca
Zuclomiphene citrateAdvanced prostate cancerTreatmentChange in frequency of moderate to severe hot flashesII (completed)NCT03646162ADTVeru Inc.
Toremifene citrateProstate cancer on androgen deprivation therapyPreventionPercentage of subjects at 24 months with at least one new vertebral fractureIII (completed)NCT00129142ADTGTx
ToremifeneProstate cancer on androgen deprivation therapyPreventionThe efficacy of toremifene in the reduction in the risk of new bone fracture occurrencesIII (withdrawn)NCT01214291ADTGTx
Raloxifene hydrochlorideProstate cancer undergoing surgeryTreatment
(neoadjuvant therapy)
Collection and interrogation of prostate cancer samplesII (withdrawn)NCT03147196Bicalutamide
Mayo Clinic
TamoxifenAdenocarcinoma of the prostate gland but with no evidence of distant metastasisTreatmentThe extent of gynaecomastia and breast pain by treatment groupII (completed)NCT00637871CasodexAstraZeneca
ToremifeneHigh grade prostatic intraepithelial neoplasia (PIN)PreventionThe efficacy of toremifene in the prevention of prostate cancerIII (completed)NCT00106691GTx
TamoxifenProstate cancer with stage T1a, T1b T2a or T2b Nx MxTreatmentTotal prostate volumeII (unknown)NCT00866554Bicalutamide, dutasteride,
CHU de Quebec-Universite Laval
Toremifene citrateHigh grade prostate intraepithelial neoplasiaPrevention
Investigational medication that reduce high grade PIN and prevent the occurrence of prostate cancerII (completed)NCT00028353GTx
FulvestrantRecurrent prostate cancerTreatmentProportion of patients who respond to treatmentII (terminated)NCT00217464Roswell Park Cancer Institute
FulvestrantHormone refractory prostate cancerTreatmentPSA reduction ≥50%II (completed)NCT00476645Stanford University
FulvestrantAdvanced prostate cancerTreatmentPSA objective response rateII (completed)NCT00244998Roswell 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.