Why Clinical Trials in 2025?

  • They test new medications or procedures.
  • They gather data on safety and effectiveness.
  • They compare new options to established treatments.
  • They might give you a treatment opportunity years ahead for the general public.

Trial Phases

Phase Main Goal Pros Cons
I Tests safety and best dose Possible early access to new drugs Limited data on effectiveness
II Looks at how well it works More information on side effects Small group of participants
III Compares new vs standard Often large, randomized trials Longer and more complex
IV Watches long-term effects Real-life data on approved treatments Some treatments may have rare side effects

Currently Approved Treatments

  1. Androgen Deprivation Therapy (ADT)
    • Lowers testosterone levels.
    • Often combined with other drugs.
  2. Hormone Pathway Blockers (enzalutamide, abiraterone, apalutamide, darolutamide)
    • Target signals that help cancer grow.
    • Can slow disease progression.
  3. Chemotherapy (docetaxel, cabazitaxel)
    • Attacks rapidly dividing cells.
    • May be used along with hormone therapy.
  4. Radiopharmaceuticals (radium-223)
    • Releases radiation at cancer sites.
    • Used for cancer that has spread to bones.
  5. PARP Inhibitors (olaparib, rucaparib)
    • Used in patients with certain genetic changes.
    • Disrupts cancer cell repair processes.

Emerging Therapies

  • PSMA-Targeted Therapies
    New agents deliver radioactive material to cells with a protein called PSMA.
    Early data points to longer control of disease [1].
  • Immunotherapy Combinations
    Some trials combine drugs like pembrolizumab with targeted agents.
    Studies are ongoing to see how different drug types work together [2].
  • Genetic Testing and Personalized Medicine
    Some trials match treatments to specific genetic changes in tumors.
    This approach may refine medication choices [3].

Practical Tips for Working with Investigators

  • Ask direct questions about trial goals and potential risks.
  • Keep a journal of your symptoms and side effects.
  • Contact the study coordinator when scheduling tests or visits.
  • Discuss your full medical history at each appointment.
  • Ask about any extra appointments or lab tests.

Questions to Ask Your Doctor

  1. Am I eligible for any clinical trials?
  2. What are the risks of joining a study?
  3. How long will the trial last?
  4. What tests or scans are involved?
  5. Can I stay on my current medications?
  6. How often will I see the research team?
  7. Will my regular doctors stay involved in my care?

References

  1. Hofman MS, Emmett L, Sandhu S, et al. [^1]
    Lancet. 2021;397(10276):797–804.

  2. Antonarakis ES, Piulats JM, Gross-Goupil M, et al. [^2]
    J Clin Oncol. 2020;38(32):3682–3694.

  3. Annala M, Vandekerkhove G, Khalaf D, et al. [^3]
    Nat Med. 2018;24(4):528–533.

 

 

 

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