Randomized control study to evaluate the efficacy of adjuvant androgen deprivation therapy after rotational IMRT in patients with high risk prostate cancer

Randomized control study to evaluate the efficacy of adjuvant androgen deprivation therapy after rotational IMRT in patients with high risk prostate cancer - Randomized control study to evaluate the efficacy of adjuvant androgen deprivation therapy after rotational IMRT in patients with high risk prostate cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008887

Enrollment

200

Registered

2012-09-10

Start date

2012-09-17

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

Patients receive Combined Androgen Blockade (CAB) with LH-RH agonist and anti-androgen for 4 months as neoadjuvant hormonal therapy. After that, patients receive 76Gy external beam radiotherapy (EBRT)

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1.High risk prostate cancer patient (by NCCN recurrence risk) 2.Performance status 0-1 (ECOG) 3.Age: 40-79 years old 4.Patients who satisfy the following (1)WBC>=3.0x103/microL (2)hemoglobin>=10.0 g/dL (3) platelet>=10x104/microL (4)erum creatinine<=2.0 mg/dL (5)AST<=100 IU/L (6)ALT<=100 IU/L 5.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Clinical stage T3b or T4 2.Patients who has metastasis with lymph node or distant lesion 3.Patients with active another cancer 4.Patients with uncontrollable hypertension 5.Patients with severe psychiatric disorders 6.Patients with connective tissue disease 7.Patients with poorly controlled diabetes 8.Patients with poorly controlled ischemic heart disease 9.Patients who had prior surgery for prostate (e.g. radical prostatectomy) 10.Patients who had prior radiotherapy (e.g. EBRT, brachytherapy) 11.Patients who had prior orchiectomy 12.Patients who are treated with steroids (except for external use for skin) 13.Patients who are treated with anti-androgen for BPH 14.Patients who considered inappropriate for this trial by physicians

Design outcomes

Primary

Measure	Time frame
PSA-progression free survival	—

Secondary

Measure	Time frame
Overall survival Cause-specific survival QOL Adverse events	—

Countries

Japan

Contacts

Public ContactShiraishi Kenshiro

The University of Tokyo Hospital Department of Radiology

kshiraishi-tky@umin.ac.jp03-3815-5411

Outcome results

None listed

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