Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment

Italian multicenter study, will enroll \~566 pts with oligometastatic hormone sensitive prostate cancer who are candidates to receive treatment with apalutamide. After 6 months from the start of treatment, patients will be randomized to receive local treatment based on the investigator's choice ( either one between primary radiotherapy or cytoreductive prostatectomy), in addition to apalutamide, or to continue just with medical therapy.

Trial Details

NCT ID
NCT05649943
Phase
NA
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Status
RECRUITING
Cancer Type
Hormone-Sensitive Prostate Cancer
Interventions
  • APA + ADT
  • Local Treatmetn RT or RP
Locations (sample)
  • Milan, Lombardy, Italy|45.46427,9.18951
  • Milan, Lombardy, Italy|45.46427,9.18951
  • Milan, Mi, Italy|45.46427,9.18951

Key Eligibility Criteria

  • Histologically confirmed diagnosis of prostate adenocarcinoma
  • Metastatic disease documented by ≥1 bone lesion with Technetium 99m (99mTc) bone scan. Individuals with only one bone lesion should have confirmati…
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) Grade ≤ 2
  • No previous treatment with antiandrogens or GnRH analogues, or a treatment ≤ 3 months.

For full eligibility, visit ClinicalTrials.gov.

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