A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan

Sponsor
Janssen Pharmaceutical K.K. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04034095
Collaborator
(none)
979
77
61.2
12.7
0.2

Study Details

Study Description

Brief Summary

The purpose of this registry study is to longitudinally observe clinical outcomes and patient-reported outcomes (PRO) for participants with high-risk metastatic hormone-naive prostate cancer (mHNPC) in the real-world setting in Japan.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
979 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Registry to Observe Clinical Outcomes of Patients With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
Actual Study Start Date :
Jul 8, 2019
Anticipated Primary Completion Date :
Jul 15, 2024
Anticipated Study Completion Date :
Aug 12, 2024

Arms and Interventions

Arm Intervention/Treatment
Cohort 1: ADT alone/ ADT + Bicalutamide

Participants with diagnosis of metastatic hormone-naive prostate cancer (mHNPC) receiving androgen-deprivation therapy (ADT) alone or ADT plus bicalutamide (combined androgen blockade [CAB]) under routine clinical practice will be observed.

Drug: Androgen-deprivation Therapy (ADT)
Participants enrolled in this study will continue to receive ADT (example- Leuprorelin, Goserelin and Degarelix) alone or in combination with other therapies in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.

Drug: Bicalutamide
Participants enrolled in this study will continue to receive bicalutamide along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.

Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide

Participants with diagnosis of mHNPC receiving ADT plus abiraterone plus prednisolone (AAP) or Docetaxel or Enzalutamide or Apalutamide under routine clinical practice will be observed.

Drug: Androgen-deprivation Therapy (ADT)
Participants enrolled in this study will continue to receive ADT (example- Leuprorelin, Goserelin and Degarelix) alone or in combination with other therapies in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.

Drug: Abiraterone
Participants enrolled in this study will continue to receive abiraterone in combination with prednisolone along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.

Drug: Prednisolone
Participants enrolled in this study will continue to receive prednisolone in combination with abiraterone along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.

Drug: Docetaxel
Participants enrolled in this study will continue to receive docetaxel along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.

Drug: Enzalutamide
Participants enrolled in this study will continue to receive enzalutamide along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.

Drug: Apalutamide
Participants enrolled in this study will continue to receive apalutamide along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants who Achieve Prostate-specific Antigen (PSA) <=0.2 ng/mL Within a Year from Registration [1 year]

    Percentage of participants who achieve prostate-specific antigen (PSA) less than or equal to (<=)0.2 nanogram per milliliter (ng/mL) within a year from registration will be reported.

  2. PSA Progression-free Survival (PSA-PFS) [Up to 5 years]

    The PSA-PFS is defined as the duration from registration to either PSA progression or death, whichever occurs first.

  3. Percentage of Participants with PSA-PFS [2 years]

    Percentage of participants with PSA-PFS at 2 years from registration will be reported.

  4. Progression-free Survival (PFS) [Up to 5 years]

    The PFS is defined as the duration from registration to either radiographic progression, clinical progression or death, whichever occurs first.

  5. Percentage of Participants with PFS [3 years]

    Percentage of participants with PFS at 3 years from registration will be reported.

  6. Overall Survival (OS) [Up to 5 years]

    The OS is defined as the duration from registration to any death.

  7. Percentage of Participants with Overall Survival (OS) [3 years]

    Percentage of participants with OS at 3 years from registration will be reported.

  8. Cancer Specific Survival (CSS) [Up to 5 years]

    The CSS is defined as the duration from registration to prostate cancer (PC)-related death. The PC-related death will be determined by each physician's discretion.

  9. Percentage of Participants with CSS [3 years]

    Percentage of participants with CSS at 3 years from registration will be reported.

  10. Time to Symptomatic Skeletal Event (TTSSE) [Up to 5 years]

    The TTSSE is defined as the duration from registration to any first symptomatic skeletal event (SSE). The SSE is defined as 1 of the following: symptomatic pathological fracture, spinal cord compression, palliative radiation to bone and surgery to bone.

  11. Patient Health Questionnaire-9 (PHQ-9) Score [Up to 5 years]

    The PHQ-9 is a multipurpose self-reported inventory used for screening, diagnosing, and measuring the severity of mental status or depression of the patient. It contains 2 weeks recall of information and scores each of the 9 Diagnostic and Statistical Manual of Mental Disorders (4th edition; DSM-IV) criteria as "0" (not at all) to "3" (nearly every day).

  12. Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Questionnaire Score [Up to 5 years]

    The FACT-P consists of the FACT-General (FACT-G) and a PC-specific subscale. The FACT-G (Version 4) contains a 27-item questionnaire and is composed of 4 dimensions of health-related quality of life (HRQoL): physical well-being, social/family well-being, emotional well-being, and functional well-being. The PC-specific subscale is composed of 12 items, which span the dimensions of sexual function, bowel/bladder function, and pain. Each item for FACT-G subscale and PC-specific subscale is rated on a 0 to 4 Likert type scale. Higher scores represent better QoL.

  13. Montreal Cognitive Assessment (MoCA) Score [Up to 5 years]

    The MoCA is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Documented diagnosis of metastatic, hormone-naïve prostate cancer (mHNPC) after 1 May 2019

  • Should have at least 2 of the 3 following high-risk factors: a Gleason score of greater than or equal to (>=) 8, at least 3-bone lesions, or the presence of visceral metastasis

  • Willing to receive androgen-deprivation therapy (ADT) containing regimens for high-risk metastatic, hormone-naïve prostate cancer (mHNPC) in the hospital which have the contract with sponsor for this study, or patient received a regimen containing ADT for high-risk mHNPC

  • Possess Japanese nationality

  • Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for the study and is willing to participate in the study. For dead cases, the ICF can be waived after approved by Independent Ethics Committee/Institutional Review Board (IEC/IRB)

Exclusion Criteria:
  • has any other active malignancies

Contacts and Locations

Locations

Site City State Country Postal Code
1 Akita University Hospital Akita Japan 010-8543
2 Juntendo University Hospital Bunkyo-Ku Japan 113-8431
3 Tokyo Medical and Dental University Hospital Bunkyo-Ku Japan 113-8519
4 Chiba University Hospital Chiba Japan 260-8677
5 Chiba Cancer Center Chiba Japan 260-8717
6 University of Yamanashi Hospital Chuo Japan 409-3898
7 Kyushu University Hospital Fukuoka Japan 812-8582
8 Fukushima Medical University Hospital Fukushima Japan 960-1295
9 Gifu University Hospital Gifu Japan 501-1194
10 Harasanshin Hospital Hakata-Ku Japan 812-0033
11 Hamamatsu University Hospital Hamamatsu Japan 431-3192
12 Saitama Medical University International Medical Center Hidaka Japan 350-1298
13 Hirosaki University Hospital Hirosaki Japan 036-8563
14 Hiroshima University Hospital Hiroshima-shi Japan 734-8551
15 Hospital of the University of Occupational and Enviromental Health Hukuoka Japan 807-8555
16 Kobe City Medical Center General Hospital Hyogo Japan 650-0047
17 Tokyo Dental College Ichikawa General Hospital Ichikawa Japan 272-8513
18 Tokyo Medical University Ibaraki Medical Center Inashiki Japan 300-0395
19 Kanazawa Medical University Hospital Kahoku-District Japan 920-0293
20 University Hospital Kyoto Perfectural University of Medicine Kamigyo Japan 602-8566
21 St.Marianna University Hospital Kanagawa Japan 216-8511
22 Kanazawa University Hospital Kanazawa Japan 920-8641
23 Nara Medical University Hospital Kashihara Japan 634-8522
24 Kimitsu Chuo Hospital Kisarazu-shi Japan 292-8535
25 Kagawa University Hospital Kita-Gun Japan 761-0793
26 Kobe University Hospital Kobe Japan 650-0017
27 Kochi Medical School Hospital Kochi Japan 783-8505
28 Dokkyo Medical University Saitama Medical Center Koshigaya Japan 343-8555
29 National Hospital Organizaiton Shikoku Cancer Center Matsuyama-Shi Japan 791-0280
30 Kitasato University Hospital Minami-Ku, Sagamihara-Shi Japan 252-0375
31 University of Miyazaki Hospital Miyazaki Japan 889-1692
32 Iwate Medical University Hospital Morioka Japan 020-8505
33 Aichi Medical University Hospital Nagakute Japan 480-1195
34 Nagasaki University Hospital Nagasaki-shi Japan 852-8501
35 Nagoya City University Hospital Nagoya Japan 467-8602
36 University of the Ryukyus Hospital Nakagami gun Japan 903-0215
37 Tokyo Metropolitan Police Hospital Nakano-ku Japan 1648541
38 Miyagi Cancer Center Natori-shi Japan 981-1293
39 Niigata University Medical & Dental Hospital Niigata Japan 951-8520
40 Okayama University Hospital Okayama Japan 700-8558
41 Kindai University Hospital Osaka-Sayama-shi Japan 589-8511
42 Osaka International Cancer Institute Osaka Japan 541-8567
43 Gunma Prefectural Cancer Center Ota Japan 373-8550
44 Shiga University of Medical Science Hospital Otsu Japan 520-2121
45 Japan Community Health Care Organization Saitama Medical Center Saitama Japan 350-8550
46 Hokkaido University Hospital Sapporo-shi Japan 060-8648
47 Sapporo Medical University Hospital Sapporo Japan 060-8543
48 Tohoku University Hospital Sendai-shi Japan 980-8574
49 Tohoku Medical And Pharmaceutical University Hospital Sendai Japan 981-8558
50 Jichi Medical University Hospital Shimotsuke Japan 329-0498
51 Showa University Hospital Shinagawa Japan 142-8666
52 Japan Community Health care Organization Tokyo Shinjuku Medical Center Shinjuku-ku Japan
53 Chutoen General Medical Center Shizuoka Japan 436-0040
54 Osaka University Hospital Suita-shi Japan 565-0871
55 Osaka Medical and Pharmaceutical University Hospital Takatsuki Japan 569-8686
56 Tokushima University Hospital Tokushima Japan 770-8503
57 Toranomon Hospital Tokyo Japan 105-8470
58 The Jikei University Hospital Tokyo Japan 105-8471
59 Nippon Medical School Hospital Tokyo Japan 113-8603
60 The Cancer Institute Hospital of JFCR Tokyo Japan 135-8550
61 Tokyo Medical University Hospital Tokyo Japan 160-0023
62 Teikyo University Hospital Tokyo Japan 173-8606
63 Ehime University Hospital Toon-shi Japan 791-0295
64 Toyama University Hospital Toyama-shi Japan 930-0194
65 Fujita Health University Hospital Toyoake Japan 470-1192
66 University of Tsukuba Hospital Tsukuba-City Japan 305-8576
67 Mie University Hospital Tsu Japan 514-8507
68 Yamaguchi University Hospital Ube Japan 755-8505
69 Wakayama Medical University Hospital Wakayama Japan 641-8510
70 Yamagata University Hospital Yamagata Japan 990-9585
71 Yokohama Rosai Hospital Yokohama Japan 222-0036
72 Yokohama City University Medical Center Yokohama Japan 232-0024
73 Yokohama City University Hospital Yokohama Japan 236-0004
74 Yokosuka Kyosai Hospital Yokosuka Japan 238-8558
75 Tottori University Hospital Yonago Japan 683-8504
76 University of Fukui Hospital Yoshida Japan 910-1193
77 Oita University Hospital Yufu Japan 879-5593

Sponsors and Collaborators

  • Janssen Pharmaceutical K.K.

Investigators

  • Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial, Janssen Pharmaceutical K.K.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT04034095
Other Study ID Numbers:
  • CR108675
  • 56021927PCR4009
First Posted:
Jul 26, 2019
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022