What prostate cancer treatments are currently in human trials?

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Current Prostate Cancer Treatments in Human Clinical Trials

Several innovative prostate cancer treatments are currently being evaluated in human clinical trials, including novel hormone therapies, immunotherapies, targeted therapies, and radiopharmaceuticals, with a focus on improving survival outcomes and quality of life for patients with advanced disease.

Novel Hormone Therapies and Combinations

  • Triplet therapy combining ADT+docetaxel+darolutamide is being evaluated in clinical trials for metastatic hormone-sensitive prostate cancer (mHSPC), showing significant overall survival benefits (OS gain: 23.0 months, HR: 0.68) 1
  • ADT+docetaxel+abiraterone+prednisone combination is recommended as first-line treatment for fit men with de novo mHSPC, especially those with multiple bone metastases or visceral metastases 1
  • Novel hormone agents (NHAs) plus ADT, including abiraterone+prednisone, apalutamide, or enzalutamide, are being evaluated for first-line treatment of mHSPC 1

Targeted Therapies

  • Olaparib, a PARP inhibitor, is being investigated after novel androgen receptor axis inhibitors for patients with mCRPC and BRCA1/2 alterations, showing improved overall survival (HR 0.69,95% CI 0.50-0.97) 1
  • Trials examining newer agents in the castration-naïve setting are emerging, potentially supporting the upfront use of agents such as docetaxel 1
  • Predictive markers to facilitate the selection of patients for specific therapies or sequences of therapies remain an unmet need and are being actively investigated 1

Radiopharmaceuticals

  • Lutetium-177 prostate-specific membrane antigen (177Lu-PSMA-617) in combination with best standard of care has shown improved radiographic progression-free survival (rPFS) and overall survival in men with mCRPC pretreated with at least one taxane and one novel androgen receptor axis inhibitor 1
  • This targeted radiopharmaceutical approach is being evaluated in patients with PSMA-expressing tumors on PET-PSMA imaging 1

Immunotherapy Approaches

  • Despite initial challenges, immunotherapy continues to be investigated in prostate cancer clinical trials, particularly in combination strategies 2, 3, 4
  • Pembrolizumab, a PD-1 blocking antibody, has been evaluated in multiple phase III clinical trials for mCRPC and mHSPC, including KEYNOTE-641, KEYNOTE-921, KEYNOTE-991, and KEYLYNK-010 2
  • While pembrolizumab has not benefited unselected metastatic prostate cancer patients when combined with chemotherapy, next-generation hormonal agents, or PARP inhibitors, research continues to identify biomarkers and patient subsets who may benefit 2, 4

Combination Therapies

  • Effective combination therapies are being investigated to improve outcomes, particularly for castration-resistant disease 1
  • Cabazitaxel is being evaluated in combination with prednisone or prednisolone for the treatment of adult patients with mCRPC previously treated with a docetaxel-containing regimen 5
  • Large-scale, prospective randomized trials testing the optimal sequencing of treatments are ongoing but have not yet been reported 1

Clinical Trial Participation

  • The St Gallen Advanced Prostate Cancer Consensus Conference (APCCC) Expert Panel strongly encourages the inclusion of men with advanced prostate cancer in clinical trials 1
  • Participation in clinical trials is particularly important given the rapidly evolving treatment landscape and the need to identify optimal treatment sequences and combinations 1

Common Pitfalls and Considerations

  • Novel imaging methods for patient selection and response claiming increased sensitivity and specificity have not been adequately tested in prospective clinical trials 1
  • Treatment selection should consider disease extent and location, prior treatments, host factors, patient preferences, and logistical and economic constraints 1
  • Global access to new therapeutics varies across regions, and the financial burden to patients and healthcare systems must be factored into treatment decisions 1
  • Careful patient selection is crucial, as some castration-resistant phenotypes may be more responsive to hormonal strategies, others to cytotoxics, and others to biologic approaches 1

References

1
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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