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

Official title

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)

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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).]

Secondary outcome measures (7)

• proportion of patients with undetectable PSA level after 3 cycles of treatment (each cycle is 28 days). [Time frame: At the end of the 3rd cycle of treatment (each cycle is 28 days).]
• PSA50 response rate and PSA90 response rate at the end of the 3rd treatment cycle (each cycle is 28 days). [Time frame: At the end of the 3rd cycle of treatment (each cycle is 28 days).]
• PSA50 response rate and PSA90 response rate at the end of the 6th treatment cycle (each cycle is 28 days). [Time frame: At the end of the 6th cycle of treatment (each cycle is 28 days).]
• Conventional imaging and PSMA-PET/CT imaging features at baseline [Time frame: Baseline (Before trial treatment)]
• Proportion of patients with ≤ 10 metastases on PSMA-PET/CT imaging at the end of the third treatment cycle (each cycle is 28 days). [Time frame: At the end of the 3rd cycle of treatment (each cycle is 28 days).]
• Comparison of imaging features between conventional imaging and PSMA PET/CT. [Time frame: At the end of the 3rd and 6th cycle of treatment (each cycle is 28 days).]
• Feasibility and safety of performing cRP±MDT treatment [Time frame: At the end of the 6th cycle of treatment (each cycle is 28 days).]

Eligibility criteria

Inclusion criteria

• 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);
• M1a/b disease with the presence of 1-10 visible metastases at diagnosis by conventional imagine including bone scan (ECT) and CT or MRI of the chest, abdomen, and pelvis;
• With initial systemic treatment of apalutamide plus ADT and willing and expected to comply with treatment and follow up schedule \[No more than 2-month systemic treatment before enrollment (including ADT and ADT combined with short-term first-generation anti-androgen therapy (flutamide or bicalutamide); To maximize enrollment, patients who had started apalutamide plus ADT before enrollment are allowed into the study provided that they are otherwise eligible and therapy was initiated no longer than 2 months before enrollment\];
• Fit to undergo cytoreductive radical prostatectomy and radiotherapy to the visible sites of metastases;
• ECOG PS score is 0-1;
• Adequate organ function;
• Life expectancy ≥ 12 months.

Exclusion criteria

• 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;

• >2-month ADT or first-generation antiandrogens (bicalutamide, flutamide etc.);
• Any other novel hormonal therapies (enzalutamide, darolutamide, abiraterone etc.) except ≤ 2-month apalutamide plus ADT listed in inclusion criteria;
• Any chemotherapy;
• local treatment or metastatic treatment for primary prostate cancer or metastases;
• Any immunotherapy (PD-L1 etc.), target therapy (PARPi etc), etc;
• History of seizure or known condition that may predispose to seizure;
• History of major surgery 4 weeks before enrollment;
• Had major cardiovascular and cerebrovascular diseases within 6 months prior to the start of the study;
• Any condition that could interfere with drug absorption(e.g. unable to swallow, chronic diarrhea etc. );
• Conditions of active infection;
• History of previous or current malignant disease, except for curatively treated tumors cured for more than 3 years;
• Patients who is currently undergoing other trials;
• Unwilling or difficult to cooperate with treatment and follow-up visit;
• Other sever conditions which could interfere with trial safety or results judged by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• Fudan University Shanghai Cancer Center Pudong Hospital — Shanghai
• Fudan University Shanghai Cancer Center Xuhui Hospital — Shanghai

Publications

• Pan J, Wang B, Zhu B, Gan H, Hu X, Liu X, Li X, Wu J, Wang H, Zhang Q, Liu C, Song S, Ma X, Ye D, Zhu Y. Consolidative therapy for PSMA-avid lesions after 3 cycles of apalutamide plus androgen deprivation in metastatic hormone-sensitive prostate cancer: A prospective phase 2 single-arm trial. Eur J Nucl Med Mol Imaging. 2026 Jun 8. doi: 10.1007/s00259-026-07982-4. Online ahead of print. PMID 42252348
• Wang B, Pan J, Zhang T, Ni X, Wei Y, Li X, Fang B, Hu X, Gan H, Wu J, Wang H, Ye D, Zhu Y. Protocol for CHAMPION study: 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 androgen deprivation therapy. BMC Cancer. 2024 May 25;24(1):643. do PMID 38796422

Identifiers

NCT: NCT05717582 · PCa-CHAMPION

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗