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

Primary Purpose

Metastatic Prostate Cancer, Castration-Sensitive Prostate Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
apalutamide
androgen deprivation therapy
cytoreductive radical prostatectomy with/without pelvic lymph node dissection
metastasis-directed therapy with radiation
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

maximal-cytoreductive therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

proportion of patients with undetectable PSA level after 3 cycles of treatment (each cycle is 28 days).
It is defined as the proportion of patients with PSA≤0.2 ng/mL after 3 cycles of study 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).
It is defined as the proportion of patients with a PSA reduction of over 50% / 90%compared with baseline.
PSA50 response rate and PSA90 response rate at the end of the 6th treatment cycle (each cycle is 28 days).
It is defined as the proportion of patients with a PSA reduction of over 50% / 90%compared with baseline.
Conventional imaging and PSMA-PET/CT imaging features at baseline
Imaging features before hormonal therapy
Proportion of patients with ≤ 10 metastases on PSMA-PET/CT imaging at the end of the third treatment cycle (each cycle is 28 days).
Proportion of patients with ≤ 10 metastases on PSMA-PET/CT imaging at the end of the third treatment cycle (each cycle is 28 days).
Comparison of imaging features between conventional imaging and PSMA PET/CT.
Including prostate volume, tumor burden, distribution of metastatic lesions etc.
Feasibility and safety of performing cRP±MDT treatment
Feasibility and safety of performing cRP±MDT guided by oligopersistent metastases assessed by PSMA PET/CT

Full Information

First Posted
January 25, 2023
Last Updated
February 4, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05717582
Brief Title
Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment
Acronym
CHAMPION
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Cancer, Castration-Sensitive Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
maximal-cytoreductive therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
apalutamide
Intervention Description
Patients receive apalutamide 240mg,qd,po.
Intervention Type
Drug
Intervention Name(s)
androgen deprivation therapy
Intervention Description
Patients receive systemic ADT.
Intervention Type
Procedure
Intervention Name(s)
cytoreductive radical prostatectomy with/without pelvic lymph node dissection
Intervention Description
Patients receive cytoreductive radical prostatectomy with/without pelvic lymph node dissection.
Intervention Type
Radiation
Intervention Name(s)
metastasis-directed therapy with radiation
Intervention Description
Patients receive metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases.
Primary Outcome Measure Information:
Title
proportion of patients with undetectable PSA level after 6 cycles of treatment (each cycle is 28 days).
Description
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).
Time Frame
At the end of the 6th cycle of treatment (each cycle is 28 days).
Secondary Outcome Measure Information:
Title
proportion of patients with undetectable PSA level after 3 cycles of treatment (each cycle is 28 days).
Description
It is defined as the proportion of patients with PSA≤0.2 ng/mL after 3 cycles of study treatment (each cycle is 28 days).
Time Frame
At the end of the 3rd cycle of treatment (each cycle is 28 days).
Title
PSA50 response rate and PSA90 response rate at the end of the 3rd treatment cycle (each cycle is 28 days).
Description
It is defined as the proportion of patients with a PSA reduction of over 50% / 90%compared with baseline.
Time Frame
At the end of the 3rd cycle of treatment (each cycle is 28 days).
Title
PSA50 response rate and PSA90 response rate at the end of the 6th treatment cycle (each cycle is 28 days).
Description
It is defined as the proportion of patients with a PSA reduction of over 50% / 90%compared with baseline.
Time Frame
At the end of the 6th cycle of treatment (each cycle is 28 days).
Title
Conventional imaging and PSMA-PET/CT imaging features at baseline
Description
Imaging features before hormonal therapy
Time Frame
Baseline (Before trial treatment)
Title
Proportion of patients with ≤ 10 metastases on PSMA-PET/CT imaging at the end of the third treatment cycle (each cycle is 28 days).
Description
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).
Title
Comparison of imaging features between conventional imaging and PSMA PET/CT.
Description
Including prostate volume, tumor burden, distribution of metastatic lesions etc.
Time Frame
At the end of the 3rd and 6th cycle of treatment (each cycle is 28 days).
Title
Feasibility and safety of performing cRP±MDT treatment
Description
Feasibility and safety of performing cRP±MDT guided by oligopersistent metastases assessed by PSMA PET/CT
Time Frame
At the end of the 6th cycle of treatment (each cycle is 28 days).

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center Pudong Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Fudan University Shanghai Cancer Center Xuhui Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beihe Wang, M.D.
Phone
+8602164135590
Email
med_wangbh@163.com
First Name & Middle Initial & Last Name & Degree
Yao Zhu, M.D.
First Name & Middle Initial & Last Name & Degree
Beihe Wang, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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