Trials / Not Yet Recruiting
Not Yet RecruitingNCT05717582
Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment
A Prospective Study of Maximal-Cytoreductive Therapies for Patients With de Novo Metastatic Hormone-sensitive Prostate Cancer Who Achieve Oligopersistent Metastases During Systemic Treatment With Apalutamide Plus ADT (CHAMPION Study)
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (estimated)
- Sponsor
- Fudan University · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | apalutamide | Patients receive apalutamide 240mg,qd,po. |
| DRUG | androgen deprivation therapy | Patients receive systemic ADT. |
| PROCEDURE | cytoreductive radical prostatectomy with/without pelvic lymph node dissection | Patients receive cytoreductive radical prostatectomy with/without pelvic lymph node dissection. |
| RADIATION | metastasis-directed therapy with radiation | Patients receive metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases. |
Timeline
- Start date
- 2023-05-01
- Primary completion
- 2025-12-31
- Completion
- 2026-12-31
- First posted
- 2023-02-08
- Last updated
- 2023-02-08
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05717582. Inclusion in this directory is not an endorsement.