Tests surgery and radiation on remaining prostate cancer spots during treatment
Tests surgery and radiation for men with newly found spread prostate cancer.
Plain-language title generated from the registry record
Registry title: Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment
Key facts
- Where
- Shanghai, ChinaSee the 2 sites
- Phase
- Phase 2
Where in China
- Fudan University Shanghai Cancer Center Pudong HospitalShanghai, ChinaNo longer taking part
- Fudan University Shanghai Cancer Center Xuhui HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fudan University
- Trial code
- NCT05717582
- Record updated
- 8 February 2023
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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 major surgery 4 weeks before enrollment; Had major cardiovascular and cerebrovascular diseases within 6 months prior to the start of the study; History of previous or current malignant disease, except for curatively treated tumors cured for more than 3 years; History of allergies, hypersensitivity, or intolerance to any drug used in the study; History of seizure or known condition that may predispose to seizure; Any condition that could interfere with drug absorption(e.g. unable to swallow, chronic diarrhea etc. ); Conditions of active infection; Other sever conditions which could interfere with trial safety or results judged by the investigator; 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); Patients who is currently undergoing other trials; Unwilling or difficult to cooperate with treatment and follow-up visit.