Table 2.
Drug Category | Clinical Trial Title | Number ClinicalTrials.gov ID | Phase | Study Start Date | Estimated Enrollment | Status | Intervention |
---|---|---|---|---|---|---|---|
Anti-diabetic | Metformin Hydrochloride as First-Line Therapy in Treating Patients with Locally Advanced or Metastatic PCa | NCT01243385 | II | 1 December 2010 | 44 | Completed | Metformin |
Anti-diabetic | Castration Compared to Castration Plus Metformin as First Line Treatment for Patients with Advanced PCa | NCT01620593 | II | 1 April 2011 | 41 | Completed | Metformin |
Anti-diabetic | Prevention of Metabolic Syndrome and Increased Weight Using Metformin Concurrent to ADT and Radiotherapy for Locally Advanced PCa | NCT01996696 | II | 1 September 2014 | 104 | Recruiting | Metformin |
Anti-diabetic | Repurposing Metformin as Anticancer Drug in Advanced PCa (Mansmed) | NCT03137186 | II | 1 January 2017 | 120 | Unknown | Metformin |
Anti-diabetic | Study of Metformin Plus Oligomeric Procyanidin Complex for Pharmacologic Manipulation of AGE Levels in PCa Patients | NCT03465345 | Ib | 1 July 2018 | 0 | Withdrawn | Metformin + oligomeric procyanidin complex |
Anti-diabetic | Drug-Drug Interaction of SHR3680 with Digoxin, Rosuvastatin Calcium and Metformin Hydrochloride | NCT04621669 | I | 1 November 2020 | 18 | Not yet recruiting | Metformin hydrochloride + SHR3680 + digoxin + rosuvastatin |
Anti-hyperlipidemic | Impact of Adjuvant Statin Therapy in Patients who Underwent Radical Prostatectomy for Locally Advanced PCa | NCT01759836 | II | 1 October 2012 | 354 | Unknown | Atorvastatin vs. placebo |
Anti-parasitic | Low, Intermediate, or High Dose Suramin in Treating Patients with Hormone-Refractory PCa | NCT00002723 | III | 1 January 1996 | 390 | Completed | Suramin |
Anti-parasitic | Combination Chemotherapy with Suramin Plus Doxorubicin in Treating Patients with Advanced Solid Tumors | NCT00003038 | I | 1 October 1997 | 20 | Completed | Doxorubicin + suramin |
Anti-parasitic | Akt Inhibitor MK2206 and Hydroxychloroquine in Treating Patients with Advanced Solid Tumors, Melanoma, Prostate or Kidney Cancer | NCT01480154 | I | 1 November 2011 | 62 | Active, not recruiting | Hydroxycloroquine + Akt inhibitor MK2206 |
Anti-helminthic | Enzalutamide and Niclosamide in Treating Patients with Recurrent or Metastatic CRPC | NCT03123978 | I | 1 January 2017 | 12 | Recruiting | Enzalutamide + niclosamide |
Anti-helminthic | Niclosamide and Enzalutamide in Treating Patients With CRPC | NCT02532114 | I | 1 December 2015 | 5 | Completed | Niclosamide + enzalutamide |
Anti-fungal | Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients with PCa | NCT02494713 | II | 1 October 2015 | 4 | Terminated | Degarelix + Doxorubicin + Ketoconazole + Docetaxel + Estramusine |
Anti-fungal | Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced PCa | NCT02560051 | II | 1 November 2015 | 19 | Terminated | Doxorubicin + ketoconazole + docetaxel + estramustine |
Antiviral | A Study of Aplidin (Plitidepsin) in Subjects with Advanced PCa | NCT00780975 | II | 1 February 2005 | 8 | Terminated | Plitidepsin |
NSAID | Dexamethasone, Aspirin, and Diethylstilbestrol in Treating Patients with Locally Advanced or Metastatic PCa | NCT00316927 | III | 1 December 2002 | 260 | Completed | Dexamethasone + aspirin vs. dexamethasone + diethylstilbestrol + aspirin |
Steroid | Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients with Advanced PCa (PROSTATA) | NCT00705822 | III | 1 August 2006 | 54 | Terminated | Docetaxel + prednisone vs. docetaxel + estramusine + hydrocortisone |
Steroid | Docetaxel, Prednisone, and Vatalanib in Treating Patients with Advanced PCa | NCT00293371 | I/II | 1 September 2006 | 6 | Terminated | Docetaxel + prednisone + vatalanib |
Steroid | A Safety and Efficacy Study of Abiraterone Acetate in Participants with Advanced PCa who Failed ADT and Docetaxel-Based Chemotherapy | NCT00474383 | II | 1 November 2006 | 47 | Completed | Abiraterone acetate + glucocorticoid |
Steroid | An Open-Label Study of YM155 + Docetaxel in Subjects with Advanced Hormone Refractory PCa and Other Solid Tumors | NCT00514267 | I/II | 1 May 2007 | 32 | Completed | YM 155 + docetaxel + prednisone vs. YM 155 + docetaxel |
Steroid | An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants with PCa Who Failed ADT and Docetaxel-Based Chemotherapy | NCT00485303 | II | 1 June 2007 | 58 | Completed | Abiraterone acetate + prednisone |
Steroid | AMG 386 and Abiraterone for Advanced PCa | NCT01553188 | II | 1 February 2012 | 36 | Completed | Abiraterone + prednisone vs. abiraterone + prednisone + AMG |
Steroid | Cabozantinib Plus Docetaxel and Prednisone for Advanced PCa | NCT01683994 | I | 1 September 2012 | 49 | Completed | Carbozantinib + docetaxel + prednisone |
Steroid | Reducing Dexamethasone Around Docetaxel Infusion (REDEX) | NCT02776436 | I | 1 January 2016 | 46 | Active, not recruiting | Dexamethasone |
Steroid | Cognitive Effects of AR Directed Therapies for Advanced PCa | NCT03016741 | IV | 1 March 2017 | 100 | Recruiting | GnRH agonist/antagonist + prednisone + abiraterone acetate vs. GnRH agonist/antagonist + enzalutamide |
Steroid | Intermittent ADT for Stage IV Castration Sensitive PCa | NCT03511196 | 1b | 1 September 2018 | 17 | Active, not recruiting | ADT + abiraterone + prednisone |
Steroid | A Study of Nivolumab or Placebo in Combination with Docetaxel in Men with Advanced CRPC (CheckMate 7DX) | NCT04100018 | III | 1 February 2020 | 984 | Recruiting | Nivolumab + prednisone + docetaxel vs. placebo |
Immunosuppressive drug | Sirolimus Before Surgery in Treating Patients with Advanced Localized PCa | NCT00311623 | I/II | 1 August 2006 | 32 | Completed | No intervention vs. low dose rapamycin vs high dose rapamycin |
Synthetic vitamin D analogue | Paricalcitol in Treating Patients with Advanced PCa and Bone Metastases | NCT00634582 | II | 1 January 2009 | 2 | Terminated | Paricalcitol |
Vitamin D analogue | Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/PCa Patients Treated with Denosumab/Zoledronic Acid | NCT02274623 | I | 1 December 2014 | 33 | Completed | CTAP101 capsules (vitamin D analogue) |
Vitamin D | Changes in Bone Mineral Density and Fracture Risk in Patients Receiving ADT for PCa | NCT00536653 | N/A * | 1 October 1999 | 618 | Completed | Bicalutamide + calcium/vitamin D supplementation vs. LHRH agonists + calcium/vitamin D supplementation |
Bisphosphonate | Study of Zoledronic Acid for Patients with Hormone-sensitive Bone Metastases from PCa | NCT00242567 | III | 1 December 2005 | 522 | Completed | Zoledronic acid |
Bisphosphonate | Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients with Locally Advanced Nonmetastatic PCa Undergoing Radiation Therapy and Hormone Therapy | NCT00329797 | III | 1 March 2006 | 109 | Completed | Calcium + zoledronic acid + radiation therapy + LHRH + vitamin D vs. calcium + radiation therapy + LHRH + vitamin D |
Bisphosphonate | Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects with Advanced Cancer or Multiple Myeloma. | NCT00330759 | III | 1 June 2006 | 1779 | Completed | Denosumab + zoledronic acid |
Somatostatin analogue | Effects of Octreotide Acetate on Circulating Levels of Chromogranin A in Advanced PCa Patients | NCT00166725 | II | 1 February 2004 | 40 | Completed | Octreotide acetate |
Anticoagulant | Standard Therapy with or Without Dalteparin in Treating Patients with Advanced Breast, Lung, Colorectal, or PCa | NCT00003674 | III | 1 December 1998 | 141 | Completed | Dalteparin |
Anticoagulant | Effects of Nadroparin in Patients with Lung, Pancreas or PCa | NCT00312013 | III | 1 May 2006 | 503 | Completed | Nadroparin |
Synthetic retinoid | Fenretinide In Treating Patients with Advanced or Metastatic Hormone-Refractory Prostate Cancer | NCT00077402 | II | 1 February 2004 | 50 | Completed | Fenretinide |
Other | Preoperative Thalidomide Followed by Radical Retropubic Prostatectomy in Select Patients with Locally Advanced PCa | NCT00038181 | II | 5 October 2000 | 18 | Completed | Thalidomide preoperatively |
Other | Trial of Docetaxel-Samarium in Patients with Hormone-Refractory Advanced PCa | NCT00126230 | II | 1 January 2004 | 55 | Terminated | Docetaxel-samarium |
Other | Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced PCa | NCT00328614 | I | 1 March 2003 | 32 | Completed | Samarium + hormonal and radiation therapy |
Other | Study of Chitosan for Pharmacologic Manipulation of AGE Levels in PCa Patients | NCT03712371 | Ib/2 | 1 January 2019 | 45 | Recruiting | Chitosan |
Other | Study of Pharmacologic Manipulation of AGE Levels in PCa Patients Receiving ADT | NCT02946996 | II | 1 December 2016 | 45 | Recruiting | AGE |
Other | A Phase I/II Trial of 2-Deoxyglucose (2DG) for the Treatment of Advanced and Hormone Refractory PCa | NCT00633087 | I/II | 1 March 2011 | 12 | Terminated | 2-deoxyglucose |
Other | Omega-3 Fatty Acids in Treating Patients with Advanced PCa | NCT00996749 | 1 May 2011 | 0 | Withdrawn | Omega-3 PUFA supplementation | |
Other | Hyperpolarized C-13 Pyruvate as a Biomarker in Patients with Advanced Solid Tumor Malignancies | NCT02913131 | I/II | 1 October 2016 | 20 | Terminated | Pyruvate |
Other | Nanoparticle Albumin-Bound Rapamycin in Treating Patients with Advanced Cancer with mTOR Mutations | NCT02646319 | I | 1 January 2016 | 2 | completed | Rapamycin |
Other | Enzalutamide/Leuprolide ± Abiraterone/Pred in PCa | NCT02268175 | II | 1 October 2014 | 75 | Active, not recruiting | Enzalutamide + leuprolife + abiraterone acetate + prednisone vs. enzalutamide + leuprolide |
Other | Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced PCa and Anorexia | NCT04803305 | I | 1 May 2021 | 40 | Recruiting | PF-06946860 |
Other | Study of XL102 as Single-Agent and Combination Therapy in Subjects with Solid Tumors | NCT04726332 | I | 1 February 2021 | 298 | Recruiting | XL102 + fulvestrant + abiraterone + prednisone |
Abbreviations: ADT: Androgen Deprivation Therapy; AGE: Advanced Glycation End products; AR: Androgen Receptor; CRPC: castration resistant prostate cancer; PCa: prostate cancer. * N/A: Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.