Multicenter, randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of low-dose chlormadinone acetate on the rate of continued active surveillance of patients with low-risk prostate cancer.

Multicenter, randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of low-dose chlormadinone acetate on the rate of continued active surveillance of patients with low-risk prostate cancer. - CSPOR-URO 01:PROSAS-Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012284

Enrollment

220

Registered

2013-11-13

Start date

2014-03-26

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

Chlormadinone group: Chlormadinone acetate at 50 mg/day (PROSTAL&amp

reg

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.)

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Rate of continued active surveillance	—

Secondary

Measure	Time frame
-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)	—

Countries

Japan

Contacts

Public ContactAkira Yamao

Public Health Research Foundation Comprehensive Support Project for Oncology Research

info@cso.or.jp03-5287-2636

Outcome results

None listed

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