Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment

Sponsor
Fudan University
Study ID
NCT05717582
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Castration-Sensitive Prostate Cancer
  • Metastatic Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • apalutamide — DRUG
    Patients receive apalutamide 240mg,qd,po.
  • androgen deprivation therapy — DRUG
    Patients receive systemic ADT.
  • cytoreductive radical prostatectomy with/without pelvic lymph node dissection — PROCEDURE
    Patients receive cytoreductive radical prostatectomy with/without pelvic lymph node dissection.
  • metastasis-directed therapy with radiation — RADIATION
    Patients receive metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases.

Study Details

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.

Key Dates

Start date
May 1, 2023
Status verified
Feb 2023
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
47 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: maximal-cytoreductive therapy
    Patients with de novo mCSPC who achieve ≤10 oligopersistent metastases on PSMA PET CT after initial 3-month systemic treatment with apalutamide plus ADT will receive cytoreductive radical prostatectomy with/without PLND and metastasis-directed therapy with radiation.

Primary Outcome Measure

proportion of patients with undetectable PSA level after 6 cycles of treatment (each cycle is 28 days). [ Time Frame: At the end of the 6th cycle of treatment (each cycle is 28 days). ]

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