The impact of prostatectomy combined with systemic therapy in men with metastatic prostate cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0004129
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 30
4.1.1 Histologically proven adenocarcinoma of the prostate.
4.1.2 Evidence of metastasis by MRI/CT scan, bone scan, or histologic confirmation.
4.1.3 Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (solid organ metastasis).
4.1.4 If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET, bone scan and MRI, modality at the discretion of the treating physician).
4.1.5 No previous local therapy for prostate cancer (i.e. prostate radiation, cryotherapy, etc.).
4.1.6 Give informed consent.
4.1.7 Prostate deemed resectable by surgeon.
4.1.8 Must be male and 18 years or older
4.1.9 Plans to start or has already started ADT no longer than 6 months prior to consent.
4.1.10 ECOG Performance Status of 0 or 1.
4.1.11 Organ functions compatible for surgery.
HgB = 9 g/dL
Platelets >80,000/mcL
AST = 2x ULN
ALT = 2x
4.2.1 Males under the age of 18.
4.2.2 Refuses to give informed consent.
4.2.3 Deemed to have unresectable disease by surgeon.
4.2.4 Received ADT for more than 6 months prior to consent.
4.2.5 Life expectancy of less than 6 months prior to consent.
4.2.6 Known spinal cord compression.
4.2.7 DVT/PE in the past 6 months prior to consent.
4.2.8 Previous local therapy for prostate cancer.
4.2.9 Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety : Complications of each treatment;Efficacy : Biochemical recurrence free survival
- Secondary Outcome Measures
Name Time Method Overall survival