The placebo-controlled parallel-group comparative study for patients with low-risk prostate cancer

JRCT ID: jRCTs061180024

Registered date:20/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: prostatic cancer
• Date of first enrollment: 24/03/2014
• Target sample size: 220
• Countries of recruitment: No,Japan
• Study type: Interventional

Intervention(s)

Chlormadinone group:
Chlormadinone acetate at 50 mg/day (PROSTAL® TABLETS 25, 1 tablet at a time, b.i.d.)

Placebo group:
Chlormadinone acetate at 0 mg/day (placebo tablet, 1 tablet at a time, b.i.d.)

Outcome(s)

• Primary Outcome: Rate of continued active surveillance

Secondary Outcome

PSA (prostate-specific antigen) level
-Testosterone level
-Successful treatment period
-Tumor progression level (measured by Gleason score, TNM stage, exacerbation rate and incidence of distant metastasis, etc.)
-QOL (SF-8, EPIC, I-PSS)
-Safety (measured by incidence of adverse events and discontinuation rate due to adverse events)

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

(1) A patient who has been diagnosed with prostate cancer based on histology (biopsy).
(2) A patient with T1c, N0, M0, Gleason score <= 6, PSA <= 10 ng/mL.
(3) A patient with untreated prostate cancer.
(4) If a patient is already receiving AS, the AS must have been started within the previous 6 months.
(5) A male patient aged 65 years or older at the time of enrollment.
(6) A patient with an ECOG performance status (PS) of 0 or 1.
(7) A patient who has provided written informed consent to participate in this study.

Exclude criteria

(1) A patient with active double cancer (synchronous double cancer and metachronous double cancer with a disease-free interval of less than 5 years, excluding carcinoma in situ and intramucosal carcinoma lesions, which are considered to be cured by local treatment).
(2) A patient with serious hepatic disorder and hepatic disease.
(3) A patient with serious disease (e.g., chronic renal failure, cardiac failure, myocardial infarction within the previous 3 months, uncontrolled hypertension, uncontrolled diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonia, immunodeficiency, etc.).
(4) A patient with serious drug allergy/hypersensitivity.
(5) A patent with active urogenital infection.
(6) A patient with prostatitis with the chief symptom of pain.
(7) A patient with severe lower urinary tract symptoms (LUTS) requiring surgical intervention.
(8) A patient with a history of surgical treatment of the prostate.
(9) A patient who is not allowed to discontinue treatment with antiandrogen or 5a-reductase inhibitor.
(10) A patient with an expected survival of less than 5 years.
(11) A patient whom the investigator considers to be ineligible as a subject.

Related Information

• Primary Sponsor: Sugimoto Mikio
• Source(s) of Monetary Support: ASKA Pharmaseutial Co., ltd.
• Secondary ID(s): UMIN000012284