Prostate cancer
Conditions
Interventions
Control Group:Standard Androgen Deprivation Therapy with Conventional Symptomatic Management
Experimental Group:Standard Androgen Deprivation Therapy Combined with Modified Shenqi Dihuang Decoction (with Individualized Modifications) for Hormone-Sensitive Prostate Cancer
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Locally Advanced Prostate Cancer: Prostate cancer with invasion into bladder rectum pelvis external sphincter levator ani muscle or internal obturator muscle or pelvic lymph node metastasis distal to the aortic bifurcation with maximum metastatic lymph node diameter =3 cm; 2) Low Tumor Burden Metastatic Prostate Cancer: =3 bone metastases without extra-axial skeletal metastases (e.g. pelvis vertebrae) and absence of visceral metastases; 3) Inclusion Criteria: Aged 50-80 years life expectancy >12 months no prior radical prostatectomy radiotherapy or chemotherapy for prostate cancer; 4) Ethical Requirements: Voluntary participation with signed informed consent and willingness to comply with treatment protocols.
Exclusion criteria
Exclusion criteria: 1) Critically ill patients with life expectancy <6 months; 2) Hypersensitivity to Modified Shenqi Dihuang Decoction; 3) Concomitant primary malignancy other than prostate cancer; 4) Severe primary diseases of cardiovascular hepatic renal or hematopoietic systems; 5) Psychiatric disorders or Alzheimer's disease with inability to cooperate with treatment; 6) Non-adherence to clinical research protocol requirements; 7) Subjects currently enrolled in other drug clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6- and 12-month Non-Progression Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) and Overall Survival (OS);NRS;ECOG; | — |
Countries
China
Contacts
Public ContactXu dongliang
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed