The impact of prostatectomy combined with systemic therapy in men with metastatic prostate cancer

SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 multi-institution randomized prospective clinical trial evaluating the impact of cytoreductive radical prostatectomy combined with best systemic therapy on oncologic and quality of life outcomes in men with newly diagnosed metastatic prostate cancer

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0004129

Enrollment

Registered

2019-07-09

Start date

2021-02-24

Completion date

Unknown

Last updated

2021-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Procedure/Surgery : To every subjects, the standard treatment for metastatic prostate cancer, ADT +/- Docetaxel will be administered. To whom were allocated to surgery group, radical prostatecto

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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 ULN

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Safety : Complications of each treatment;Efficacy : Biochemical recurrence free survival	—

Secondary

Measure	Time frame
Overall survival	—

Countries

Korea, Republic of

Contacts

Public ContactJae Young Joung

National Cancer Center

urojy@ncc.re.kr+82-31-930-1740

Outcome results