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

NCT ID: NCT05717582

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

apalutamide

Intervention Type: DRUG

Patients receive apalutamide 240mg,qd,po.

androgen deprivation therapy

Intervention Type: DRUG

Patients receive systemic ADT.

cytoreductive radical prostatectomy with/without pelvic lymph node dissection

Intervention Type: PROCEDURE

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

metastasis-directed therapy with radiation

Intervention Type: RADIATION

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

Interventions

apalutamide

Patients receive apalutamide 240mg,qd,po.

Intervention Type: DRUG

androgen deprivation therapy

Patients receive systemic ADT.

Intervention Type: DRUG

cytoreductive radical prostatectomy with/without pelvic lymph node dissection

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

Intervention Type: PROCEDURE

metastasis-directed therapy with radiation

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

Intervention Type: RADIATION

Eligibility Criteria

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.

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.

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.);

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Ding-Wei Ye

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center Pudong Hospital

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center Xuhui Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Facility Contacts

Beihe Wang, M.D.

Role: primary

med_wangbh@163.com

+8602164135590

References

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.

Reference Type: DERIVED

PMID: 38796422 (View on PubMed)

Other Identifiers

PCa-CHAMPION

Identifier Type: -

Identifier Source: org_study_id