Stereotactic ablative radiation against metastatic lesion detected by DWIBS for High risk Prostate Cancer

Stereotactic ablative radiation against metastatic lesion detected by DWIBS for High risk Prostate Cancer - STARCAP

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000044546

Enrollment

Registered

2021-06-15

Start date

2021-08-02

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

Prostate cancer

Interventions

Metastatic-directed radiation therapy against DWIBS positive lesion after radical prostatectomy with extended pelvis lymph node dissection(if number of DWIBS positive lesion 4 or less) Hormonal ther

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Diagnosis of prostate adenocarcinoma as confirmed by a genitourinary pathologist 2) High risk prostate cancer according to NCCN classification (serum PSA >20 ng/mL OR ISUP Gleason grade group 4 or more OR cT>=3a ) 3) No lymph node and distant metastasis confirmed by CT scan and bone scintigraphy 4) Patients who exhibited DWIBS positive (metastatic lesions detected) by two independent radiologists 5) Prostate cancer detected by Prostate 1.5T or higher sophisticated MRI before radical prostatectomy 6) Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1 7) Patient is suitable for radical prostatectomy with PLND and radiation/hormonal therapy 8) Ability to give voluntary written informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1) History of any prostate cancer therapy 2) Severe heart disease (NYHA criteria>=class 3) 3) Cerebral vascular disease with higher cerebral dysfunction 4) Liver disease (total bilirubin> 3*ULN OR ALT/AST>5* ULN) 5) Uncontrollable diabetes mellitus (HbA1c >8.0%) 6) Contraindication for MRI 7) Patient who is considered ineligible for enrolling the study by a principal investigator or sub-investigator

Design outcomes

Primary

Measure	Time frame
3-year composite disease progression free survival rate	—

Secondary

Measure	Time frame
progression-free survival the rate of adverse events QOL recurrence rate of metastatic lesion with SBRT detection rate of DWIBS time to CRPC time to new metastatic lesion rate of hormonal therapy 36-months after protocol therapy rate of metastatic-directed therapy Analysis of survival and other clinical parameters with historical control of high risk prostate cancer using propensity-score matching method	—

Measure

Time frame

progression-free survival the rate of adverse events QOL recurrence rate of metastatic lesion with SBRT detection rate of DWIBS time to CRPC time to new metastatic lesion rate of hormonal therapy 36-months after protocol therapy rate of metastatic-directed therapy Analysis of survival and other clinical parameters with historical control of high risk prostate cancer using propensity-score matching method

—

Countries

Japan

Contacts

Public ContactTakeshi Sasaki

Mie University Hospital Nephro-Urologic Surgery and Andrology

t-sasaki@med.mie-u.ac.jp059-232-1111

Outcome results

None listed

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