Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fudan University
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.);
Clareo Health | Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment
