UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000027795
Receipt number	R000029208
Scientific Title	The phaseII study of the efficacy of Abirateron acetate and Dutasteride therapy for castration resistant prostate cancer.
Date of disclosure of the study information	2017/07/01
Last modified on	2025/07/02 15:53:53

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Basic information

Public title

The phaseII study of the efficacy of Abirateron acetate and Dutasteride therapy for castration resistant prostate cancer.

Acronym

The efficacy of Abirateron and Dutasteride for CRPC.

Scientific Title

The phaseII study of the efficacy of Abirateron acetate and Dutasteride therapy for castration resistant prostate cancer.

Scientific Title:Acronym

The efficacy of Abirateron and Dutasteride for CRPC.

Region

Japan

Condition

castration resistant prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

YES

Objectives

Narrative objectives1

The purpose of this study is to evaluate the effect and safety of androgen synthesis inhibition with abiraterone and dutasteride for the patients with castration resistant prostate cancer and benign prostate hyperplasia before the therapy of Docetaxel.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

the rate of patients with over fifty percent reduction in PSA

Key secondary outcomes

Time-to-treatment failure

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients is treated with abiraterone (1,000 mg daily) and prednisone (5 mg daily) for two 4-week cycles. After this time, dutasteride (0.5 mg daily) is added for 12 weeks. Patients continue on the three-drug regimen until study withdrawal or radiographic disease progression.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

50 years-old <=

Age-upper limit

90 years-old >

Gender

Male

Key inclusion criteria

1)advanced prostate cancer (>stage III) with androgen deprivation therapy
2)a serum total testosterone <50 ng/dL
3)PSA progression as defined by the Prostate Cancer Clinical Trials Working Group
4)patients with benign prostate hyperplasia (IPSS>9)
5)
Hematologic and laboratory criteria including
White blood cell >3,000/mm3
Hemoglobin>8.0 g/dL
Platelet count>100000/mm3
aspartate aminotransferase (AST) <100 IU/L
alanine aminotransferase (ALT) <100 IU/L
Serum creatinine <1.5 mg/dL
patients provide written informed consent

Key exclusion criteria

1)Patients took 5alpha-reductase inhibitors previously
2)AST >101 IU/L or ALT>101 IU/L or Child-Pugh score C
3)HbA1c > 10%
4)serum potassium < 3.5 mEq/l

Target sample size

Research contact person

Name of lead principal investigator

1st name Hideyasu

Middle name

Last name Matsuyama

Organization

Yamaguchi Graduate School of Medicine

Division name

Urology

Zip code

7558505

Address

1-1-1, Minamikogushi, Ube, Yamaguchi, Japan

TEL

0836-22-2275

Email

hidde@yamaguchi-u.ac.jp

Public contact

Name of contact person

1st name Keita

Middle name

Last name Kobayashi

Organization

Yamaguchi Graduate School of Medicine

Division name

Urology

Zip code

7558505

Address

1-1-1, Minamikogushi, Ube, Yamaguchi, Japan

TEL

0836-22-2275

Homepage URL

Email

kkoba@yamaguchi-u.ac.jp

Sponsor or person

Institute

Department od Urology, Yamaguchi Graduate School of Medicine

Institute

Department

Personal name

Funding Source

Organization

Grant-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Center For Clinical Research, Yamaguchi University Hospital

Address

1-1-1 Minamikogushi, Ube city

Tel

0836-22-2428

Email

me223@yamaguchi-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 01 Day

Related information

URL releasing protocol

None

Publication of results

Published

Result

URL related to results and publications

https://accp1.onlinelibrary.wiley.com/doi/10.1002/jcph.2191

Number of participants that the trial has enrolled

Results

21 CRPC patients with a median age of 76 and PSA of 3.9 were analyzed. 85.7 percent had a 50 percent or greater PSA decline. PSA dropped to 3.4 ng per mL at 4 weeks and 0.78 ng per mL at 20 weeks. Seven patients experienced treatment failure and the median time was not reached. Dutasteride reduced 3 keto 5 alpha abiraterone. Higher levels were linked to shorter time to failure. HSD3B1 wild type had better outcomes.

Results date posted

2025 Year 07 Month 02 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2022 Year 12 Month 09 Day

Baseline Characteristics

Overall, 28 patients were enrolled in this study of which 4 were excluded because they did not meet the inclusion or exclusion criteria. 1 patient withdrew consent before treatment initiation. Abiraterone treatment was discontinued before combination therapy with abiraterone and dutasteride in 2 patients by patient request related to adverse events and economic reasons. Finally, 21 patients were analyzed in this study. Patient characteristics are shown in Table 1. The median age at enrollment was 76 years with an interquartile range of 71 to 83 years. The median PSA concentration at enrollment was 3.9 ng per mL with an interquartile range of 3.0 to 5.9 ng per mL. Gleason score was greater than 8 in 13 patients which was 61.9 percent. 8 patients or 38.1 percent and 13 patients or 61.9 percent were diagnosed with nonmetastatic and metastatic CRPC respectively. No patients were treated with ketoconazole.

Participant flow

All patients provided written informed consent. Within two weeks after enrollment, treatment was initiated with abiraterone at a dose of 1000 milligrams daily and prednisolone at a dose of 10 milligrams daily for four weeks. After four weeks of treatment with abiraterone and prednisolone, dutasteride at a dose of 0.5 milligrams daily was added. During treatment, castration status was maintained either surgically or medically. Blood samples were taken from the patients approximately three hours after the last intake of abiraterone. Serum concentrations of abiraterone and its metabolites were obtained at baseline and at two, four, six, eight, twelve, sixteen, and twenty weeks after abiraterone initiation until treatment discontinuation.

Adverse events

Toxicities were observed in three patients (14.2%). Grade 2 gastric ulcer and diabetes mellitus in one case each were observed during the 4 weeks after abiraterone initiation. Grade 1 AST/ALT increase was observed in patients after adding dutasteride. No grade >3 adverse events were observed and no patients discontinued the trial treatment because of adverse events.

Outcome measures

The primary end point was a 50 percent PSA response rate defined as the rate of patients experiencing a maximum PSA decline of 50 percent or more on trial treatment. Pretreatment PSA concentrations were measured within 2 weeks before abiraterone initiation. PSA responses at 4 and 20 weeks and maximum decline after abiraterone initiation were evaluated.

Secondary end points were time to treatment failure and safety. Time to treatment failure was defined as the duration from the date of abiraterone initiation to the date of treatment discontinuation due to progression or adverse event. Treatment discontinuation was judged by the physician according to biochemical radiographic and clinical evaluations in addition to toxicities. Treatment discontinuation by patient request including economic burden or polypharmacy was defined as censor. Patients with no events were censored at the last follow up visit. Serum PSA concentrations were evaluated at baseline and at 4, 6, 8, 12, 16, and 20 weeks after abiraterone initiation and every 12 weeks after 20 weeks by protocol. Computed tomography and bone scans were performed at baseline and at 4, 12, and 20 weeks after abiraterone initiation. All adverse events during treatment with abiraterone with or without dutasteride were collected and evaluated by Common Terminology Criteria for Adverse Events version 4.0.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 04 Month 27 Day

Date of IRB

2017 Year 04 Month 26 Day

Anticipated trial start date

2017 Year 08 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2017 Year 06 Month 17 Day

Last modified on

2025 Year 07 Month 02 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029208