Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorFudan University
About this trial
To assess the feasibility and safety of Maximal cytoreductive therapies in patients with de novo mCSPC who achieve ≤10 oligopersistent metastases on PSMA PET CT after initial 3-month systemic treatment with apalutamide plus ADT. Maximal cytoreductive therapies consist of 1.cytoreductive radical prostatectomy with/without PLND guided by post-treatment PET 2.metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases. All patients receive continuous systemic treatment with apalutamide plus ADT.
Eligibility criteria
Qualifiers
Able to understand and willing to sign the informed consent;
Aged ≥18 years;
Histologically or cytologically confirmed prostate adenocarcinoma (primary small cell carcinoma or signet-ring cell carcinoma of the prostate are not allowed, however adenocarcinoma with neuroendocrine differentiation accounting ≤10% is allowed);
Newly diagnosed prostate cancer (within 3 months prior to enrollment);
Disqualifiers
History of allergies, hypersensitivity, or intolerance to any drug used in the study;
Had the contraindications or is intolerant to cRP or RT;
Had any visceral metastases (brain, liver, lung etc.) on screening conventional imaging (bone scans, CT or MRI);
Prior Received any of the following treatments for primary and metastatic prostate cancer;
Trial design
Treatments tested in this trial
- apalutamide
- androgen deprivation therapy
- cytoreductive radical prostatectomy with/without pelvic lymph node dissection
- metastasis-directed therapy with radiation
Treatment groups
47 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov