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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apalutamide | Drug | Patients receive apalutamide 240mg,qd,po. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). |
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Inclusion Criteria:
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;
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center Pudong Hospital | Shanghai | Shanghai Municipality | 200000 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42252348 | Derived | 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. | |
| 38796422 |
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| androgen deprivation therapy |
| Drug |
Patients receive systemic ADT. |
|
| cytoreductive radical prostatectomy with/without pelvic lymph node dissection | Procedure | Patients receive cytoreductive radical prostatectomy with/without pelvic lymph node dissection. |
|
| metastasis-directed therapy with radiation | Radiation | Patients receive metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases. |
|
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). | 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 | 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). | 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. | 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 | 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). |
| Fudan University Shanghai Cancer Center Xuhui Hospital |
| Shanghai |
| Shanghai Municipality |
| 200000 |
| China |
|
| Derived |
| 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. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C572045 | apalutamide |
| D000726 | Androgen Antagonists |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D055585 | Physical Phenomena |
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