Study of the difference in clinical efficacy by the difference between the GnRH agonist and GnRH antagonist when adding short-term androgen deprivation therapy to definitive radiation therapy for localized intermediate-risk prostate cancer

Study of the difference in clinical efficacy by the difference between the GnRH agonist and GnRH antagonist when adding short-term androgen deprivation therapy to definitive radiation therapy for localized intermediate-risk prostate cancer - Study of the difference in clinical efficacy by the difference between the GnRH agonist and GnRH antagonist when adding short-term androgen deprivation therapy to definitive radiation therapy for localized intermediate-risk prostate cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021806

Enrollment

100

Registered

2016-06-01

Start date

2016-10-01

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

goserelin acetate is administered subcutaneously in the abdomen once every 4 weeks at a dose of 3.6 mg. The initial dose of degarelix is 240 mg given as 2 subcutaneous injections of 120 mg in the abdo

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Be a definitive histological diagnosis of PCa by needle biopsy 2) Have intermediate-risk localized PCa as follows. cT2b -T2c or Gleason score: 7, or PSA 10-20 ng/ml 3) Recieved written informed consent prior to initiating this clinical study

Exclusion criteria

Exclusion criteria: 1) Have previously received hormonal therapies including GnRH agonists, GnRH antagonists, and antiandrogen agents, estorogen agents or orchiectomy for PCa 2) Be using 5alpha reductase inhibitor 3) Have severe asthma (e.g. use inhaled corticosteroid that is necessary for daily life), anaphylactic reaction, severe urticaria and complication or medical history of angioedema 4) Be sensitive to mannitol 5) Have multiple malignancies 6) Have myocardial infarction, unstable angina, congestive heart failure, a history of symptomatic peripheral vascular disease within 12 months prior to incorporation 7) Have a history of cerebrovascular disorders, including transient ischemic attack (TIA) 8) Have ALT>= 100 IU/L or total bilirubin >= 1.3 mg/dL 9) Be considered as inappropriate by the investigator

Design outcomes

Primary

Measure	Time frame
Freedom from biochemical progression	—

Secondary

Measure	Time frame
Castration achievement rate (testosterone value 50ng / ml, 20ng / ml) after 1 month, 3 months, and 6 months of androgen deprivation therapy Normalization of serum testosterone levels after completion of androgen deprivation therapy Adverse event evaluation using CTCAE ver. 4.0 Overall survival	—

Countries

Japan

Contacts

Public ContactTsutomu Nishiyama

Uonuma Institute of Community Medicine Niigata University Medical and Dental Hospital Department of Urology

nisiyama@med.niigata-u.ac.jp+81-25-777-3200

Outcome results

None listed

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