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

February 4, 2023 updated by: Ding-Wei Ye, Fudan University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Fudan University Shanghai Cancer Center Pudong Hospital
      • Shanghai, Shanghai, China, 200000
        • Fudan University Shanghai Cancer Center Xuhui Hospital
        • Contact:
        • Principal Investigator:
          • Yao Zhu, M.D.
        • Sub-Investigator:
          • Beihe Wang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Able to understand and willing to sign the informed consent;
  2. Aged ≥18 years;
  3. 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);
  4. Newly diagnosed prostate cancer (within 3 months prior to enrollment);
  5. 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;
  6. 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];
  7. Fit to undergo cytoreductive radical prostatectomy and radiotherapy to the visible sites of metastases;
  8. ECOG PS score is 0-1;
  9. Adequate organ function;
  10. Life expectancy ≥ 12 months.

Exclusion Criteria:

  1. History of allergies, hypersensitivity, or intolerance to any drug used in the study;
  2. Had the contraindications or is intolerant to cRP or RT;
  3. Had any visceral metastases (brain, liver, lung etc.) on screening conventional imaging (bone scans, CT or MRI);

  4. Prior Received any of the following treatments for primary and metastatic prostate cancer;

    1. >2-month ADT or first-generation antiandrogens (bicalutamide, flutamide etc.);
    2. Any other novel hormonal therapies (enzalutamide, darolutamide, abiraterone etc.) except ≤ 2-month apalutamide plus ADT listed in inclusion criteria;
    3. Any chemotherapy;
    4. local treatment or metastatic treatment for primary prostate cancer or metastases;
    5. Any immunotherapy (PD-L1 etc.), target therapy (PARPi etc), etc;
  5. History of seizure or known condition that may predispose to seizure;
  6. History of major surgery 4 weeks before enrollment;
  7. Had major cardiovascular and cerebrovascular diseases within 6 months prior to the start of the study;
  8. Any condition that could interfere with drug absorption(e.g. unable to swallow, chronic diarrhea etc. );
  9. Conditions of active infection;
  10. History of previous or current malignant disease, except for curatively treated tumors cured for more than 3 years;
  11. Patients who is currently undergoing other trials;
  12. Unwilling or difficult to cooperate with treatment and follow-up visit;
  13. Other sever conditions which could interfere with trial safety or results judged by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: maximal-cytoreductive therapy
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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).
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).
It is defined as the proportion of patients with a PSA reduction of over 50% / 90%compared with baseline.
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).
It is defined as the proportion of patients with a PSA reduction of over 50% / 90%compared with baseline.
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)
Imaging features before hormonal therapy
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).
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).
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).
Including prostate volume, tumor burden, distribution of metastatic lesions etc.
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).
Feasibility and safety of performing cRP±MDT guided by oligopersistent metastases assessed by PSMA PET/CT
At the end of the 6th cycle of treatment (each cycle is 28 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2023

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCa-CHAMPION

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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