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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

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.

Eligibility criteria

Qualifiers

Age > 18

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 confirmation of that lesion on CT or MRI.

Eastern Cooperative Oncology Group Performance Status (ECOG PS) Grade ≤ 2

Disqualifiers

Pathologic findings consistent with small cell, ductal, or neuroendocrine prostate cancer.

Known brain metastases.

Lymph node metastases only.

Visceral metastases.

Trial design

Treatments tested in this trial

  • APA + ADT
  • Local Treatmetn RT or RP

Treatment groups

566 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Lead sponsor

ASST Santi Paolo e Carlo

Collaborator

European Institute of Oncology

Collaborator