SHIP0804

Phase 3

• Conditions: Prostate Cancer; prostate cancer, permanent I-125 seed implantation, PSA relapse-free survival, International Prostate Symptom Score.

• Registration Number: JPRN-jRCTs031180256
• Lead Sponsor: Egawa Shin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 420

Inclusion Criteria

1.Prostate cancer classified as an intermediate risk group from clinical stage, PSA value, Gleason score of central pathology diagnosis.
2. Be previously untreated Pca.
3. ECOG PS is 0 or 1
4.The age at consent acquisition is between 20 years old and 75 years old.
5.Laboratory test values satisfy the following criteria.
1) White blood cell count over 3000 / myu L
2) Hemoglobin over 10.0 g / dL
3) Number of platelets over 100000 / myu L
4) Serum creatinine under 2.0 mg / dL
5) AST (GOT) under 100 IU / L
6) ALT (GPT) under 100 IU / L
6. Agree in writing to participate in this clinical study after receiving adequate explanation.

Exclusion Criteria

1. Have PSA over 20 ng/mL.
2. Have a biopsy Gleason score over 8.
3. Exhibit clinical stage over T2c.
4. Have a second cancer that requires treatment.
5. Have poorly-controlled hypertension (diastolic pressure over 120mmHg)
6. Have a severe psychiatric disorder, including schizophrenia and dementia.
7. Have collagen disease diabetes.
8. Have poorly-controlled diabetes.
9. Have previously received surgery for PCa.
10. Are using steroid drugs other than topical ointments.
11. Are using antiandrogenic therapy.
12. Are for any other reason considered by a Principal Investigator or Clinical Investigator to be inappropriate for participation in the present study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified