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Metastatic Prostate CancerPhase 2CHAMPIONNCT05717582

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

A Phase 2 study testing apalutamide, androgen deprivation therapy and cytoreductive radical prostatectomy with/without pelvic lymph node dissection in people with Metastatic Prostate Cancer and Castration-Sensitive Prostate Cancer, run by Fudan University at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
apalutamide, androgen deprivation therapy and cytoreductive radical prostatectomy with/without pelvic lymph node dissection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
2 sitesChina
Study dates
1 May 2023to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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];
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites

  • Fudan University Shanghai Cancer Center Pudong Hospital

    Shanghai, Shanghai Municipality, 200000

  • Fudan University Shanghai Cancer Center Xuhui Hospital

    Shanghai, Shanghai Municipality, 200000

    Beihe Wang, M.D., +8602164135590, med_wangbh@163.com

    Yao Zhu, M.D.

Other trials in China

About this study

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)

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.

Being tested
apalutamide, androgen deprivation therapy, cytoreductive radical prostatectomy with/without pelvic lymph node dissection, metastasis-directed therapy with radiation
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • apalutamideDrug

    Patients receive apalutamide 240mg,qd,po.

  • androgen deprivation therapyDrug

    Patients receive systemic ADT.

  • cytoreductive radical prostatectomy with/without pelvic lymph node dissectionProcedure or surgery

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

  • metastasis-directed therapy with radiationRadiation

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

Study groups in NCT05717582
Study groupRoleWhat they receive
maximal-cytoreductive therapyExperimentalPatients 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.
Receives: Drug: apalutamide; Drug: androgen deprivation therapy; Procedure: cytoreductive radical prostatectomy with/without pelvic lymph node dissection; Radiation: metastasis-directed therapy with radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (7)

  1. 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).

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

  2. 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.

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

  3. 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.

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

  4. Conventional imaging and PSMA-PET/CT imaging features at baseline

    Imaging features before hormonal therapy

    Measured: Baseline (Before trial treatment)

  5. 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).

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

  6. Comparison of imaging features between conventional imaging and PSMA PET/CT.

    Including prostate volume, tumor burden, distribution of metastatic lesions etc.

    Measured: At the end of the 3rd and 6th cycle of treatment (each cycle is 28 days).

  7. Feasibility and safety of performing cRP±MDT treatment

    Feasibility and safety of performing cRP±MDT guided by oligopersistent metastases assessed by PSMA PET/CT

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start1 May 2023 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05717582
Sponsor's protocol ID
PCa-CHAMPION
Acronym
CHAMPION
Status last verified
Feb 2023
First submitted
25 Jan 2023
Last updated
8 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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. doi: 10.1186/s12885-024-12395-3.

    PubMed 38796422

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing apalutamide, androgen deprivation therapy and cytoreductive radical prostatectomy with/without pelvic lymph node dissection in people with Metastatic Prostate Cancer and Castration-Sensitive Prostate Cancer, run by Fudan University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05717582, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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