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Clinical Trials in China / NCT05717582
Starting soon Phase 2

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

NCT05717582 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Phase 2
Started
2023-05-01
Last updated
2023-02-08

Condition(s) studied

Metastatic Prostate CancerCastration-Sensitive Prostate Cancer

Investigational drug(s) / intervention(s)

apalutamide →androgen deprivation therapy →cytoreductive radical prostatectomy with/without pelvic lymph node dissectionmetastasis-directed therapy with radiation

apalutamide: Patients receive apalutamide 240mg,qd,po.

androgen deprivation therapy: Patients receive systemic ADT.

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

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

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Pudong Hospital Shanghai Shanghai Municipality
Fudan University Shanghai Cancer Center Xuhui Hospital Shanghai Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05717582 on ClinicalTrials.gov ↗ ← All trials in China