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

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 - cytoreductive radical prostatectomy combined with best systemic therapy in men with metastatic prostate cancer (SIMCAP)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036012

Enrollment

190

Registered

2019-04-01

Start date

2020-06-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

metastatic prostate cancer

Interventions

cytoreductive prostatectomy systemic therapy alone

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1 Histologically proven adenocarcinoma of the prostate. 2 Evidence of metastasis by MRI/CT scan, bone scan, or histologic confirmation. 3 Clinical stage N1 (regional node positive), M1a (distant lymph node positive), or M1b (bone metastasis). 4 If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET, bone scan and MRI). 5 No previous local therapy for prostate cancer. 6 Give informed consent. 7 Prostate deemed resectable by surgeon. 8 Must be male and 20 years or older 9 Started ADT no longer than 6 months prior to randomization. 10 ECOG Performance Status of 0 or 1. 11 Organ functions compatible for surgery. HgB>/= 9 g/dL Platelets >80,000 PT/PTT WNL Creatinine </=1.5x ULN AST/ALT </=2x ULN TBili WNL

Exclusion criteria

Exclusion criteria: 1 Males under the age of 18. 2 Refuses to give informed consent. 3 Deemed to have unresectable disease by surgeon. 4 Received ADT for more than 6 months prior to randomization. 5 Life expectancy of less than 6 months. 6 Known spinal cord compression. 7 M1c disease (solid organ metastasis). 8 DVT/PE in the past 6 months. 9 Previous local therapy for prostate cancer.

Design outcomes

Primary

Measure	Time frame
The primary endpoint for the Phase 2 portion of this study is the failure-free survival (FFS) rate at two years after randomization. Failure is defined as: biochemical recurrence, clinical progression, or death from prostate cancer.	—

Secondary

Measure	Time frame
There are seven secondary endpoints: 1) % PSA nadir < 0.2 ng/ml at six months after randomization, 2) overall complication rate, 3) time to biochemical progression, 4) time to clinical progression, 5) FFS (primary endpoint for phase 2 portion), 6) cancer-specific survival, and 7) overall survival (primary endpoint for phase 3 portion). Overall survival will switch to the primary endpoint if the study converts successfully to phase 3 trial.	—

Measure

Time frame

There are seven secondary endpoints: 1) % PSA nadir < 0.2 ng/ml at six months after randomization, 2) overall complication rate, 3) time to biochemical progression, 4) time to clinical progression, 5) FFS (primary endpoint for phase 2 portion), 6) cancer-specific survival, and 7) overall survival (primary endpoint for phase 3 portion). Overall survival will switch to the primary endpoint if the study converts successfully to phase 3 trial.

—

Countries

Japan,Asia(except Japan),North America

Contacts

Public ContactMasayoshi Nagata

Juntendo University, Graduate School of Medicine Department of Urology

m-nagata@juntendo.ac.jp03-5802-1227

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026