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PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer

Recruitingn/aAges 18 Years - anyMaleFondazione Policlinico Universitario Agostino Gem…
NCT06652607 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Prostate cancer remains the most common malignancy in men in Europe. Over the last two decades, the treatment landscape for both localized and metastatic prostate cancer has been revolutionized. For patients with metastatic castration-sensitive prostate cancer (mCSPC), the primary treatment objectives are to delay progression to metastatic castration-resistant prostate cancer (mCRPC) and to improve overall survival (OS). Although patients with PC may initially respond to androgen deprivation therapy (ADT), progression to castration resistance occurs in 10-20% of patients within 5 years. Primary ADT has been the standard of care for over 50 years. However, recent advancements have shifted treatment from ADT monotherapy for all mHSPC/mCRPC patients to more intensive approaches, which include combinations of ADT with new androgen receptor pathway inhibitors (ARPIs), chemotherapy, or both,

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged ≥ 18 years old; * Men with histologically or cytologically confirmed adenocarcinoma of the prostate with evidence of metastases; * ECOG performance status ≤2; * Staging of disease with TC + bone scintigraphy or with PET PSMA/choline; * Availability of baseline PSA and after six months (±1) from the beginning of the ADT; * Ongoing or completed treatment with at least one ARPI among abiraterone acetate, apalutamide, darolutamide and enzalutamide; * Adequate information about baseline demographic, biological, clinical and laboratory data; * Signed informed consent form, or declaration in lieu of informed consent form, if applicable. Exclusion Criteria: * Patients without evidence of histological diagnosis of prostate cancer; * No follow up visit after the beginning of therapy; * No availability of baseline informations.
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What it tests

  • Enzalutamide
  • Apalutamide (Erleada™) 60 mg or 240 mg tablets
  • Darolutamide (Nubeqa®) 300 mg tablets
  • Taxotere (docetaxel)
  • Abiraterone acetate + Prednisone or Prednisolone
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Where

1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ONCOLOGIA MEDICA
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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