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A prospective study of salvage radiotherapy combined with horrmone therapy for high-risk recurrent prostate cancer after radical prostatectomy

A prospective study of salvage radiotherapy combined with horrmone therapy for high-risk recurrent prostate cancer after radical prostatectomy - The SAHOP study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030864
Enrollment
100
Registered
2018-04-01
Start date
2018-04-01
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

Recurrent prostate cancer after radical prostatectomy

Interventions

Salvage radiotherapy (monotherapy, 70Gy/35fr to the prostate surgical bed) or Salvage radiotherapy (70Gy/35fr to the prostate surgical bed) combined with hormone therapy (LHRH analogue and bicaluta

Sponsors

Department of Urology, Nara Medical University
Lead Sponsor
Urology, Nara Prefecture General Medical Center Urology, Nara City Hospital Urology, Takai Hospital Urology, Yamato Takada Municipal Hospital Urology, Hoshigaoka Medical Center Urology, Tane General Hospital Urology, Matsuzaka Chuo General Hospital
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) History of radical prostatectomy for prostate cancer of clinical stage, T1-T3N0M0 2) Pathological stage, T0, T2, T3 3) Pathological stage, N0 or Nx 4) Continuous elevation of serum PSA level, which is 0.2 ng/mL or more 5) Serum PSA level, 1.0 ng/mL or less 6) No radiographcally-detected recurrent lesions 7) No history of radiotherapy to the pelvic for other malignant diseases 8) Age, 20 to 85 yo 9) ECOG-PS 0 or 2 10) No history of blood transfusion within 28 days before the registration 11) Sufficient organ functions within 28 days before the registration 12) Agreement for enrolment in the study with the signed form

Exclusion criteria

Exclusion criteria: Inappropriate for the enrolment by the judgement of the physician

Design outcomes

Primary

MeasureTime frame
Second biochemical recurrence-free survival

Secondary

MeasureTime frame
1) Salvage hormone therapy-free survival 2) Metastatic-free survival 3) Cancer-specific survival 4) Overall survival 5) Adverse event 6) Body composition analysis after treatment 7) Health-related quality of life after treatment

Countries

Japan

Contacts

Public ContactMakito Miyake

Nara Medical University Department of Urology

urology@naramed-u.ac.jp0744-22-3051

Outcome results

None listed

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