Prostate Cancer Clinical Trials
Prostate cancer clinical trials are used to determine just how effective promising new therapies can be. Although they are often thought of as experimental studies, clinical trials are actually conducted after a treatment has been deemed safe. Patients are carefully monitored by physicians and prostate cancer researchers throughout the entire process. Patients are never obligated to participate, and can end their participation at any time.

Is a Clinical Trial the Right Option for Your Prostate Cancer Treatment?
Clinical trials are not only safe and carefully regulated, but also an important step in determining how a new treatment can best be used to help patients. During a clinical trial, investigators will learn:
- Which doses of the treatment are most effective
- Which patients respond best to the treatment (e.g., patients with a certain stage of cancer, or patients whose tumors are made up of a certain kind of cells)
- Whether the treatment provides the best results on its own or when combined with other therapies
- What side effects might occur, and how they can be managed
Leading-Edge Prostate Cancer Trial
Moffitt Cancer Center treated the first patient in a groundbreaking clinical trial using gamma delta CAR T-cell therapy for bone-metastatic prostate cancer. This innovative treatment harnesses the unique properties of gamma delta T cells to target and attack cancerous cells, offering new hope for patients with advanced prostate cancer.
Roughly 90% of men with advanced prostate cancer will develop bone metastases.
Learn More About Our Clinical Trials
As a National Cancer Institute-designed Comprehensive Cancer Center, Moffitt is constantly conducting clinical trials to study the newest treatments for prostate cancer. We have investigated the role of hormone therapy in patients with rising prostate-specific antigen (PSA) levels after their first attempt at treatment, as well as the effectiveness of bone-strengthening therapies to help reduce the likelihood that prostate cancer will spread to the bones. These are just a small sampling of the trials we’ve conducted; we continually strive to offer our patients more effective treatment options, and our robust clinical trials program is one of the main ways we are able to do so.
To learn more about our prostate cancer clinical trials, call 1-813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form online. No referral is required; our clinical trial navigators will be happy to help you find a trial that may suit your treatment goals.
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Clinical Trials
CLINICAL TRIAL 19291
The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men with High GC Decipher® Test Scores: A Sub-aim of the VANDAAM Study (MCC #18523)
Condition: Genitourinary
Intervention:
CLINICAL TRIAL 20117
A Phase 1/2 Study of Regn5678 (Anti-psmaxcd28) with Cemiplimab (Anti-pd-1) in Patients with Metastatic Castration-Resistant Prostate Cancer
Condition: Genitourinary
Intervention: Cemiplimab (); REGN2810 (Cemiplimab); REGN5678 (); Sarilumab (); [18]F-DCFPyL ()
CLINICAL TRIAL 20832
A Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization in Patients with Localized Prostate Carcinoma and Obstructive Lower Urinary Tract Symptoms
Condition: Genitourinary
Intervention: Radiotherapy ()
CLINICAL TRIAL 50428
Metabolite Consumption in Patient-Derived Explants to Predict Therapeutic Response in Aggressive and Oligometastatic Prostate Cancer in African American Men
Condition: Genitourinary
Intervention:
CLINICAL TRIAL 21899
Phase Ib Expansion Study of CX-5461 in Patients with Solid Tumours and BRCA2 and/or PALB2 Mutation
Condition: Multiple
Intervention: CX-5461 ()
CLINICAL TRIAL 22003
A Phase II Randomized Study of Sipuleucel-T with or without Continuing New Hormonal Agents (NHA) in Metastatic Prostate Cancer with PSA Progression while on NHA and LHRH Analog
Condition: Genitourinary
Intervention: Abiraterone (); Apalutamide (); Enzalutamide (Xtandi); Provenge (Sipuleucel-T); Sipuleucel-T (); prednisone ()
CLINICAL TRIAL 22098
Non-Invasive Biomarkers in Prostate Cancer Disease Management
Condition: Genitourinary
Intervention:
CLINICAL TRIAL 22344
A Phase I Clinical Trial of an Infusion of Autologous gamma delta T cells Genetically Engineered with a Chimeric Receptor to Target the Prostate Stem Cell Antigen in Patients with Metastatic Castration Resistant Prostate Cancer
Condition: Genitourinary
Intervention: MSGV1-PSCA-8T28Z (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
CLINICAL TRIAL 22350
A Phase I/II Open Label Study to Evaluate the Safety, Cellular Kinetics, and Efficacy of AZD0754, a Chimeric Antigen Receptor (CAR) T-cell Therapy Directed Against STEAP2, in Adult Participants with Metastatic Prostate Cancer: APOLLO
Condition: Genitourinary
Intervention: AZD0754 (); AZD2287 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
CLINICAL TRIAL 22726
miRNA-Related Polygenic Risk Score and miRNA Expression on Prostate Cancer Survival
Condition: Genitourinary
Intervention:
CLINICAL TRIAL 23255
An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy in Patients with Advanced Solid Tumors
Condition: Multiple
Intervention: Olaparib (Lynparza); XL309 ()
CLINICAL TRIAL 23260
A Phase IIA study of adaptive androgen deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
Condition: Genitourinary
Intervention: Abiraterone acetate (); Apalutamide (); Darolutamide (); Decapeptyl SR (Triptorelin); Degarelix (); Eligard (Leuprolide); Enzalutamide (Xtandi); Firmagon (); Leuprolide (); Lupron (leuprolide acetate); Relugolix (Orgovyx); Taxotere (docetaxel); Triptorelin (); Zytiga (Abiraterone acetate); docetaxel ()
CLINICAL TRIAL 23303
Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical Recurrence (INDICATE)
Condition: Genitourinary
Intervention: Apalutamide (); Decapeptyl SR (Triptorelin); Degarelix (); Lupron (leuprolide acetate); Relugolix (Orgovyx); Triptorelin (); goserelin acetate (Zoladex); leuprolide acetate ()
CLINICAL TRIAL 23480
A Phase 1/2 Study of a Selective FGFR2/3 Inhibitor, CGT4859, in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors Harboring FGFR2 and/or FGFR3 Genetic Alterations
Condition: Multiple
Intervention: CGT4859 ()
CLINICAL TRIAL 23562
A Phase II Double-Blinded, Placebo-Controlled Trial of Prostate Oligometastatic Radiotherapy with or without Androgen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)
Condition: Genitourinary
Intervention: Placebo (); Radiotherapy (); Relugolix (Orgovyx)
CLINICAL TRIAL 23679
The Phase III "High Five Trial" Five Fraction Radiation for High-Risk Prostate Cancer
Condition: Genitourinary
Intervention: Radiotherapy ()
CLINICAL TRIAL 23692
A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients with Metastatic Castration-Resistant Prostate Cancer (CRPC)
Condition: Genitourinary
Intervention: ACE-232 ()
CLINICAL TRIAL 23697
A Phase 1/1b, Open-label, Multicenter, First-in-human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of VVD-159642, a RAS-PI3KA Inhibitor, as a Single Agent and in Combination in Participants With Advanced Solid Tumors
Condition: Multiple
Intervention: AMG 510 (Sotorasib); GSK1120212 (Trametinib); Sotorasib (); Trametinib (); VVD-159642 ()