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

NCT05717582 | Not Yet Recruiting Phase 2

• 1 other identifier: PCa-CHAMPION
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief 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

Metastatic Prostate Cancer; Castration-Sensitive Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• proportion of patients with undetectable PSA level after 6 cycles of treatment (each cycle is 28 days).

  It is defined as the proportion of patients with PSA≤0.2 ng/mL without disease progression or symptomatic deterioration after 6 cycles of study treatment (each cycle is 28 days).

  At the end of the 6th cycle of treatment (each cycle is 28 days).

Secondary Outcomes (7)

• proportion of patients with undetectable PSA level after 3 cycles of treatment (each cycle is 28 days).

  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).

  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).

  At the end of the 6th cycle of treatment (each cycle is 28 days).

• Conventional imaging and PSMA-PET/CT imaging features at baseline

  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).

  At the end of the 3rd cycle of treatment (each cycle is 28 days).

Study Arms (1)

maximal-cytoreductive therapy

EXPERIMENTAL

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.

Drug: apalutamide; Drug: androgen deprivation therapy; Procedure: cytoreductive radical prostatectomy with/without pelvic lymph node dissection; Radiation: metastasis-directed therapy with radiation

Interventions

apalutamide DRUG

Patients receive apalutamide 240mg,qd,po.

maximal-cytoreductive therapy

androgen deprivation therapy DRUG

Patients receive systemic ADT.

maximal-cytoreductive therapy

cytoreductive radical prostatectomy with/without pelvic lymph node dissection PROCEDURE

Patients receive cytoreductive radical prostatectomy with/without pelvic lymph node dissection.

maximal-cytoreductive therapy

metastasis-directed therapy with radiation RADIATION

Patients receive metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases.

maximal-cytoreductive therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (2)

Fudan University Shanghai Cancer Center Pudong Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Fudan University Shanghai Cancer Center Xuhui Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (1)

• 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. doi: 10.1186/s12885-024-12395-3.

  PMID: 38796422 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide; Androgen Antagonists; Radiation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 8, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

CN (2)