Metastatic Prostate Cancer, Therapy, Directly Observed
Conditions
Keywords
prostate cancer, cytoreductive prostatectomy
Brief summary
To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP)
Detailed description
To investigate the multimodality approaches for mHSPC
Interventions
PROCEDURECytoreductive prostatectomy or brachytherapy
local treatment+SOC for metastatic prostate cancer
DRUGADT+second-generation antiandrogens ± chemotherapy
SOC(Triplet or doublet therapy) for mHSPC
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized control
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male aged ≥18 and ≤75; 2. Histologically confirmed prostate adenocarcinoma; 3. Evidence of metastasis confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histology; 4. Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (visceral organ metastasis); 5. Prostate cancer has not received local treatment (e.g., prostate radiotherapy, cryotherapy, etc.); 6. The surgeon believes the prostate can be removed;
Exclusion criteria
1. The surgeon believes the disease is unresectable; 2. Life expectancy less than 2 years; 3. Active spinal cord compression; 4. History of prior local treatment for prostate cancer; 5. Difficulty swallowing, chronic diarrhea, intestinal obstruction, and other factors affecting drug intake and absorption; 6. Refusal to sign the informed consent; 7. Investigator believes the individual is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rPFS | 3 year | Assess how long a cancer patient lives without any signs of progression of their disease, as determined by radiographic evidence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of CRP in mHSPC patients | until one year after the local therapy | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Countries
China
Contacts
Primary ContactLixin Hua, M.D.
Backup ContactShangqian Wang, M.D.,PhD
Outcome results
None listed