JPRN-jRCTs031180256
Active, not recruiting
Phase 3
TRANSPERINEAL PROSTATE BRACHYTHERAPY, USING I-125 SEED WITH OR WITHOUT ADJUVANT ANDROGEN DEPRIVATION, IN PATIENTS WITH INTERMEDIATE-RISK PROSTATE CANCER: STUDY PROTOCOL FOR A PHASE III, MUTICENTER, RANDOMIZED, CONTROLLED TRIAL - SHIP0804
Egawa Shin0 sites420 target enrollmentMarch 13, 2019
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Egawa Shin
- Enrollment
- 420
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
DR-brachytherapy with I-125-seeds for prostate cancer - Offenburg results: a retrospective analysis of 260 patientsC61Malignant neoplasm of prostateDRKS00016919Ortenau Klinikum Offenburg-Kehl, Standort St. Josefsklinik260
Completed
Phase 3
RCT of Tri-Modalities with I-125 Brachy Therapy and EBRT and Short or Long Term Hormone Therapy for High-risk Localized Prostate CancerProstate CancerJPRN-UMIN000003992Kanazawa University Translational Research Informatices Center340
Not yet recruiting
Not Applicable
Transperineal prostate biopsy under local anaesthetic compared to general anaesthetic for men with suspected prostate cancerProstate cancerCancer - ProstateACTRN12620001145998Monash Health Department of Urology620
Completed
Not Applicable
Transurethral Enucleation and Resection of Prostate versus Transvesical Prostatectomy for Prostate greater than 80ml: A Prospective Randomized Studybenign proaste hyperplasiaRenal and Urogenital - Other renal and urogenital disordersACTRN12610000072011xie, keji100
Completed
Not Applicable
Transanal and transperineal total prostatectomy with total mesorectal excision for lower rectal cancer and proctal cancerower Rectal CancerJPRN-UMIN000029229Saku Central Hospital Advanced Care Center5