Therapy Detail

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Therapy Name Leuprolide
Synonyms
Therapy Description

Lupron (leuprolide) is an agonist of gonadotropin releasing hormone (GnRH), which results decreased testosterone production in males and decreased estradiol production in females, potentially leading to decreased growth of androgen-positive tumors (NCI Drug Dictionary).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Leuprolide Lupron Leuprorelin Lupron (leuprolide) is an agonist of gonadotropin releasing hormone (GnRH), which results decreased testosterone production in males and decreased estradiol production in females, potentially leading to decreased growth of androgen-positive tumors (NCI Drug Dictionary).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02736435 Phase III Leuprolide Treatment of Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused Ultrasound Withdrawn CAN 0
NCT03093272 Phase II Leuprolide Prednisone Apalutamide + Docetaxel A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer Terminated USA 0
NCT01786265 Phase II Goserelin Degarelix Abiraterone Prednisone Leuprolide Finite Androgen Ablation vs. Finite Androgen Ablation in Combination With Abiraterone Acetate and Prednisone Active, not recruiting USA 0
NCT02811809 Phase II Leuprolide Apalutamide + Leuprolide Apalutamide Plus Intermittent Hormone Therapy Versus Intermittent Hormone Therapy Alone in Prostate Cancer Withdrawn USA 0
NCT06627530 FDA approved Leuprolide Darolutamide + Leuprolide Darolutamide COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer (COAction) Recruiting BRA 0
NCT03511196 Phase I Abiraterone + Prednisone Leuprolide Goserelin Triptorelin Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer Active, not recruiting USA 0
NCT04126070 Phase II Docetaxel + Nivolumab Leuprolide Goserelin Degarelix Nivolumab + Docetaxel + ADT in Metastatic Hormone Sensitive Prostate Cancer Active, not recruiting USA 0
NCT02366494 Phase I Leuprolide Goserelin Triptorelin Bicalutamide Docetaxel Micro RNAs to Predict Response to Androgen Deprivation Therapy Completed USA 0
NCT02346253 Phase Ib/II Leuprolide Triptorelin Degarelix Bicalutamide Goserelin High-Dose Brachytherapy in Treating Patients With Prostate Cancer Active, not recruiting USA 0
NCT02278185 Phase II Goserelin Degarelix Histrelin acetate Triptorelin Leuprolide Enzalutamide Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer Completed USA 0
NCT02059213 Phase II Goserelin Palbociclib Bicalutamide Leuprolide A Phase II Study of Androgen Deprivation Therapy With or Without PD 0332991 in RB-Positive Metastatic Prostate Cancer Completed USA 0
NCT02268175 Phase II Enzalutamide Abiraterone Prednisone Leuprolide Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate Completed USA 0
NCT02064036 Phase I Bicalutamide Goserelin Leuprolide Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate Completed USA 0
NCT04484818 Phase III Goserelin Leuprolide Darolutamide + Leuprolide Darolutamide + Triptorelin Triptorelin Darolutamide + Goserelin Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study Active, not recruiting USA 0
NCT03809000 Phase II Goserelin Bicalutamide Enzalutamide Leuprolide A Trial to See What the Results Are for Radiation Therapy and Hormone Therapy vs Radiation Therapy With Enhanced Hormone Therapy With Enzalutamide for Patients With PSA Recurrence After Surgery (STEEL) Active, not recruiting USA | CAN 0
NCT05169112 Phase III Leuprolide Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy Recruiting CAN 0
NCT02319837 Phase III Leuprolide Enzalutamide Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Active, not recruiting USA | SWE | SVK | POL | NLD | ITA | GBR | FRA | FIN | ESP | DNK | CAN | BRA | AUT | AUS 2
NCT03573648 Phase II Leuprolide Avelumab + Palbociclib + Tamoxifen Avelumab + Tamoxifen Leuprolide + Palbociclib Avelumab + Leuprolide Avelumab + Leuprolide + Palbociclib Tamoxifen Goserelin Palbociclib + Tamoxifen Avelumab + Goserelin Goserelin + Palbociclib Avelumab + Goserelin + Palbociclib Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer (ImmunoADAPT) Active, not recruiting USA 0
NCT06282588 Phase II Docetaxel Leuprolide Degarelix Goserelin Triptorelin Darolutamide Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) Recruiting BEL 0
NCT02058706 Phase II Goserelin Bicalutamide Enzalutamide Leuprolide LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer Completed USA 0
NCT03261999 Phase III Leuprolide Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer Completed USA | SVK | LTU | CZE 1
NCT02685397 Phase II Enzalutamide Triptorelin Goserelin Leuprolide Management of Castration-Resistant Prostate Cancer With Oligometastases Active, not recruiting CAN 0
NCT03279250 Phase II Goserelin Triptorelin Abiraterone + Apalutamide + Prednisone Leuprolide Apalutamide Effects of Apalutamide Plus LHRH Agonist or Apalutamide Plus Abiraterone Acetate Plus LHRH Agonist for Six Months for Prostate Cancer Patients at High Risk for Recurrence Completed USA 0
NCT00541047 Phase III Leuprolide Goserelin Bicalutamide Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer (RADICALS) Completed GBR | CAN 0
NCT01746849 Phase II Leuprolide Cyclophosphamide Thiotepa Palifermin Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Active, not recruiting USA 0
NCT06654336 Phase II Leuprolide Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC) (RATIONAL-PCS) Not yet recruiting CAN 0
NCT02972060 Phase II Triptorelin Leuprolide Degarelix Goserelin Darolutamide ODM-201 vs Androgen Deprivation Therapy in Hormone naive Prostate Cancer Active, not recruiting ITA | FRA | ESP | BEL 0
NCT04557059 Phase III Apalutamide + Triptorelin Triptorelin Apalutamide + Goserelin Apalutamide + Leuprolide Leuprolide Goserelin A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Prostate-Specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Positive Hormone-Sensitive Prostate Cancer Participants (PRIMORDIUM) Active, not recruiting USA | TUR | SWE | SVK | POL | LBN | ITA | HUN | FIN | ESP | DNK | DEU | CZE | BRA | BEL | AUT | AUS 4
NCT06378866 Phase II Degarelix Goserelin Darolutamide Relugolix Triptorelin Enzalutamide Histrelin acetate Abiraterone + Prednisone Leuprolide Apalutamide Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial (DIVINE) Recruiting USA 0
NCT03944434 Phase II Anastrozole + Ribociclib Letrozole + Ribociclib Leuprolide Goserelin Triptorelin FACILE: FeAsibility of First-line riboCIclib in oLdEr Patients With Advanced Breast Cancer (FACILE) Active, not recruiting ITA 0
NCT03678025 Phase III Docetaxel Nilutamide Triptorelin Bicalutamide Leuprolide Degarelix Goserelin Flutamide Prednisone Abiraterone Histrelin acetate Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer Recruiting USA | CHE 3
NCT02663908 Phase III Degarelix Leuprolide A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease Terminated USA | SVK | POL | GRC | GBR | FRA | FIN | DEU | CZE | CAN 2
NCT02689921 Phase II Anastrozole Letrozole Leuprolide Pertuzumab + Trastuzumab Exemestane NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer (NEOADAPT) Unknown status USA 0
NCT04787744 Phase II Goserelin Degarelix Relugolix Nilutamide Triptorelin Histrelin acetate Docetaxel + Prednisone Leuprolide Apalutamide Abiraterone + Prednisone Flutamide Abiraterone + Methylprednisolone Bicalutamide Docetaxel Enzalutamide Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (VA STARPORT) Recruiting USA 0
NCT01674140 Phase III Goserelin Anastrozole Letrozole Leuprolide Everolimus Tamoxifen Exemestane S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer (e3) Active, not recruiting USA 1
NCT02941926 Phase III Letrozole + Ribociclib Leuprolide Goserelin Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC Completed USA | SWE | SVN | SVK | POL | NOR | NLD | LBN | ITA | ISR | HUN | GRC | GBR | FRA | FIN | ESP | DNK | CZE | CAN | BGR | BEL | AUT | ARG 15
NCT03085095 Phase III Relugolix Leuprolide A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer (HERO) Completed USA | SWE | SVK | POL | NZL | NLD | ITA | GBR | FRA | FIN | ESP | DNK | DEU | CAN | BRA | BEL | AUT | AUS 4
NCT00936390 Phase III Flutamide Goserelin Leuprolide Triptorelin Bicalutamide Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer Active, not recruiting USA | CAN 0
NCT02023463 Phase I Goserelin Enzalutamide Leuprolide Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer Active, not recruiting USA 0
NCT03899077 Phase II Triptorelin Goserelin Degarelix Leuprolide Apalutamide Radiotherapy Combined With a LHRH (Ant)Agonist Versus Apalutamide in Patients With Biochemical Recurrence After RP (SAVE) Recruiting BEL 0
NCT04331717 Phase II Leuprolide Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer (BASH-PC) Withdrawn USA 0
NCT04423211 Phase III Apalutamide + Leuprolide Apalutamide + Goserelin Leuprolide Goserelin Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Using PET/CT Imaging Recruiting USA 0
NCT02064582 Phase II Leuprolide Enzalutamide Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer Completed USA 0
NCT02057939 Phase II Enzalutamide Leuprolide Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM) Completed USA 0
NCT02234115 Phase III Leuprolide Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma Completed USA | SVK | POL | LTU | DEU | CZE | AUT 1
NCT06397703 Phase III Leuprolide Degarelix Relugolix ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer Recruiting USA 0
NCT01717053 Phase II Leuprolide Abiraterone Prednisone Goserelin Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer Completed USA 0
NCT01338987 Phase II Tacrolimus Busulfan Methotrexate Leuprolide Cyclophosphamide Fludarabine Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation Completed USA 0
NCT05050084 Phase III Buserelin Relugolix Degarelix Goserelin Leuprolide Histrelin acetate Triptorelin Darolutamide + Goserelin Bicalutamide Darolutamide + Degarelix Darolutamide + Leuprolide Darolutamide + Triptorelin Buserelin + Darolutamide Darolutamide + Histrelin acetate Flutamide Darolutamide + Relugolix Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score Recruiting USA | CAN 0
NCT00223665 Phase II Leuprolide Flutamide Intermittent Hormone Therapy in Men With Localized Prostate Cancer After Radiation Therapy or Radical Prostatectomy Completed USA 0
NCT02472275 Phase I Leuprolide Pexidartinib Goserelin Degarelix PLX3397, Radiation Therapy, and Antihormone Therapy in Treating Patients With Intermediate- or High-Risk Prostate Cancer Completed USA 0
NCT04302454 Phase III Leuprolide Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy (ADOPT) Active, not recruiting NLD 0


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