Unique ID issued by UMIN | UMIN000017242 |
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Receipt number | R000019997 |
Scientific Title | Effectiveness of Adjuvant Intermittent Endocrine Therapy Following Neoadjuvant Endocrine Therapy and External Beam Radiation Therapy in Men With Locally Advanced Prostate Cancer |
Date of disclosure of the study information | 2015/05/01 |
Last modified on | 2020/10/29 17:51:40 |
Effectiveness of Adjuvant Intermittent Endocrine Therapy Following Neoadjuvant Endocrine Therapy and External Beam Radiation Therapy in Men With Locally Advanced Prostate Cancer
RCT on the Effectiveness of Intermittent Hormonal Therapy After EBRT
Effectiveness of Adjuvant Intermittent Endocrine Therapy Following Neoadjuvant Endocrine Therapy and External Beam Radiation Therapy in Men With Locally Advanced Prostate Cancer
RCT on the Effectiveness of Intermittent Hormonal Therapy After EBRT
Japan |
prostate cancer
Urology | Radiology |
Malignancy
NO
To clarify the optimal duration and methods for adjuvant endocrine therapy after external beam radiation therapy (EBRT) in patients with locally advanced prostate cancer.
Others
The present assessment of combination therapy with EBRT and endocrine therapy for locally advanced prostate cancer may be of positive concern. However, it may be difficult to answer how long neoadjuvant and/ or adjuvant endocrine therapy should be used. There have been no RCTs comparing the treatment efficacy and QOL between long-term adjuvant endocrine therapy and intermittent adjuvant endocrine therapy after treatment with EBRT and neoadjuvant endocrine therapy for locally advanced prostate cancer. To answer uncertainties on the above issues, the present multi-center RCT was conducted as a national cancer research project, which has been supported by the Ministry of Health, Labor and Welfare in Japan.
Confirmatory
Pragmatic
Phase III
biochemical relapse-free survival
overall survival, cancer-specific survival and longitudinal QOL assessment
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Central registration
2
Treatment
Medicine |
LHRH-agonist is injected all participants until 6 months after completing EBRT every 4 weeks or 3 months according to the drug information.
Adjuvant long-term androgen deprivation therapy (ADT) group: ADT following to EBRT continue for 5 years in total (including neoadjuvant and concomitant ADT)
Adjuvant intermittent androgen deprivation therapy (ADT) group: ADT must be stopped 6 months after the day of final EBRT treatment. Then, stop or start to ADT according to the protocol during intermittent ADT stage
Not applicable |
79 | years-old | >= |
Male
1)Pathologically confirmed prostate cancer
2)Clinical stage is T3N0M0 or T4N0M0 (bladder neck invasion only)
3)Untreated prostate cancer
4)Performance status is 0 or 1
5)Aged younger than 80 years
6)Laboratory data is fit the following criteria within 14 days before the registration
a)White blood cell is 3.0X103/ul or higher, Hemoglobin levels is 10.0g/dl or higher and Platelet is 10X10000/ul or higher
b) Serum creatinine levels is 2.0 mg/dl or lower, GOT is 100 U/L or lower, GPT is 100 U/L or lower
7) Restriction of concomitant medication and treatment
a) No history of undergoing prostate surgery for benign prostatic hyperplasia, which includes transurethral resection of the prostate (TUR-P), subcapsular prostatectomy, or other operation or thermotherapy to the prostate.
b) No medication of adrenocortical steroid agent
c) No medication of antiandrogen for benign prostatic hyperplasia
8) Written informed consent must be done and get agreement on the enrollment of the present study by participants
1) Having uncontrolled other malignancy
2) Having uncontrolled hypertension (Diastolic blood pressure 120mmHg or higher)
3) Having severe disease in brain or central nerve system
4) Having collagen disease
5) Having uncontrolled diabetes mellitus
6) Having any other problem that researchers judge unfit for the present study
300
1st name | Kazuto |
Middle name | |
Last name | Ito |
Gunma University
Urology
3718511
3-39-22, Showa-machi, Maebashi, Gunma, 3718511, Japan
0272208306
kzito@gunma-u.ac.jp
1st name | Atsuko |
Middle name | |
Last name | Ohyama |
Gunma University
Urology
3718511
3-39-22, Showa-machi, Maebashi, Gunma, 3718511, Japan
0272208303
a-ohyama@gunma-u.ac.jp
Department of Hygiene and Preventive Medicine, School of Health Sciences and Nursing, University of Tokyo
the Ministry of Health, Labor
and Welfare in Japan
Japanese Governmental office
National Cancer Center Hospital
Sapporo Medical University School of Medicine
The Cancer Institute Hospital of JFCR
Graduate School of Medical Sciences, Kyushu University
Osaka Medical Center for Cancer and Cardiovascular Diseases
Tokyo Metropolitan Cancer and Infections disease Center Komagome Hospital
Koshigaya Hospital, Dokkyo Medical University
Kitazato University Hospital
Tokyo Medical Center
Shikoku Cancer Center
Ibaraki Prefectural Central Hospital and Cancer Center
Gunma Prefectual Cancer Center
Isesaki Municipal Hospital
Miyagi Cancer Center
National Cancer Center Hospital
Clinical Investigation and Research Unit
3-39-15, Showa-machi, Maebashi, Gunma, 3718511, Japan
027-220-8740
gunmaciru-office@umin.ac.jp
YES
12-14
The Ministry of Health, Labor and Welfare in Japan
15-2
The Ministry of Health, Labor and Welfare in Japan
群馬大学病院(群馬県)、国立がん研究センター中央病院(東京都)、札幌医科大学医学部(北海道)、がん研有明病院(東京都)、九州大学大学院医学研究院(福岡県)、大阪府立成人病センター(大阪府)、がん・感染症センター都立駒込病院(東京都)、獨協医科大学越谷病院(埼玉県)、北里大学医学部(神奈川県)、東京医療センター(東京都)、四国がんセンター(愛媛県)、茨城県立中央病院(茨城県)、群馬県立がんセンター(群馬県)、伊勢崎市民病院(群馬県)、宮城県立がんセンター(宮城県)
2015 | Year | 05 | Month | 01 | Day |
http://onlinelibrary.wiley.com/doi/10.1002/pros.20171/abstract
Published
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
303
Median follow-up duration after randomization was 8.2 years. Arms 1 and 2 enrolled 136 and 144 patients, respectively. Of them, 24 and 30 had biochemical progression, and five and six died due to prostate cancer, respectively. The 5-year bRFS rates were 84.8% and 82.8% in arm 1 and arm 2, respectively (hazard ratio [HR], 1.132; 95%CI, 0.744-1.722). Non-inferiority of intermittent ADT against continuous ADT was not confirmed statistically.
2019 | Year | 04 | Month | 25 | Day |
2020 | Year | 06 | Month | 23 | Day |
Patients with locally advanced prostate cancer
Patients with locally advanced prostate cancer were randomized after 6 months of induction by ADT if the prostate-specific antigen level was <10 ng/mL. A total of 280 participants were divided randomly into two arms between 2000 and 2006. All participants underwent 72-Gy EBRT combined with 2 months of concomitant and 6 months of adjuvant ADT. Thereafter, the patients were treated with 5 years of continuous ADT (arm 1) or intermittent ADT (arm 2).
There was no grade 3 or worse adverse events in the study
The definition of PSA recurrence was the modified Phoenix definition, which is the PSA nadir + 2 ng/mL during the on-phase of ADT. PSA relapse was defined as tumor progression to castration registrant status. Clinical relapse was defined as progressive disease at a new site, local progression, worsening performance status, or body weight loss due to progression of prostate cancer regardless of ADT status.
The primary endpoint at the start of the trial was the biochemical relapse-free rate (bRFR). However, most clinical trials have been used biochemical relapse-free survival (bRFS), which is defined events as the last date of PSA relapse or any clinical relapse if it occurs earlier than the PSA relapse, or any cause of death. Therefore, bRFS was used as a primary endpoint in the final analysis. The secondary endpoints were overall survival (OS), CSS, and a QOL assessment.
Completed
2000 | Year | 10 | Month | 01 | Day |
2000 | Year | 11 | Month | 28 | Day |
2001 | Year | 01 | Month | 01 | Day |
2013 | Year | 03 | Month | 31 | Day |
2014 | Year | 03 | Month | 31 | Day |
2015 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2015 | Year | 04 | Month | 22 | Day |
2020 | Year | 10 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019997
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