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Trial Title:
Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment
NCT ID:
NCT05717582
Condition:
Metastatic Prostate Cancer
Castration-Sensitive Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Hypersensitivity
Androgens
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
apalutamide
Description:
Patients receive apalutamide 240mg,qd,po.
Arm group label:
maximal-cytoreductive therapy
Intervention type:
Drug
Intervention name:
androgen deprivation therapy
Description:
Patients receive systemic ADT.
Arm group label:
maximal-cytoreductive therapy
Intervention type:
Procedure
Intervention name:
cytoreductive radical prostatectomy with/without pelvic lymph node dissection
Description:
Patients receive cytoreductive radical prostatectomy with/without pelvic lymph node
dissection.
Arm group label:
maximal-cytoreductive therapy
Intervention type:
Radiation
Intervention name:
metastasis-directed therapy with radiation
Description:
Patients receive metastasis-directed therapy with radiation guided by post-treatment
oligopersistent metastases.
Arm group label:
maximal-cytoreductive therapy
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.
Criteria for 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.
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center Pudong Hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Facility:
Name:
Fudan University Shanghai Cancer Center Xuhui Hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Contact:
Last name:
Beihe Wang, M.D.
Phone:
+8602164135590
Email:
med_wangbh@163.com
Investigator:
Last name:
Yao Zhu, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Beihe Wang, M.D.
Email:
Sub-Investigator
Start date:
May 1, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05717582
