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Primary androgen deprivation therapy with radical prostatectomy or radical radiotherapy and androgen deprivation therapy alone in prostate cancer patients with bone metastases: a prospective, randomized, multicenter study.

Primary androgen deprivation therapy with radical prostatectomy or radical radiotherapy and androgen deprivation therapy alone in prostate cancer patients with bone metastases: a prospective, randomized, multicenter study.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16008421
Enrollment
Unknown
Registered
2016-05-05
Start date
2016-05-16
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

RP+ADT:Radical prostatectomy+androgen deprivation therapy
ADT:androgen deprivation therapy
RT+ADT:Radical radiotherapy+androgen deprivation therapy

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. male; 2. To be aged 18 Years old or oldder; 3. Histologically confirmed prostate adenocarcinoma; 4. Bone scan, CT, and / or MRI were confirmed as bone metastases in patients with stage M1b, and the number of bone lesions was less than 5; 5. Hormone sensitive prostate cancer ; received endocrine therapy within 6 months of PSA decreased to less than 4ng / ml, serum testosterone level less than 1.7nmol/Lor 50ng/dl and metastasis regression or stability, no new lymph node metastasis and abdominal viscera metastasis; 6. ECOG performance status 0-1; 7. Life expectance longer than 5 years; 8. Subjects volunteered to participate and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. The presence of bone metastases other than visceral metastases; 2. Patients with lymph node metastases outside the pelvic region; 3. Patients with high surgical risk disease cant tolerate surgery: such as severe cardiovascular disease, pulmonary dysfunction; 4. Suffering from severe bleeding tendency or blood coagulation disorders; 5. Laboratory test results were obviously abnormal, such as: AST and ALT is more than 2.0 x normal value upper limit of normal (ULN); White blood cell count less than 2.0x109/L; Hemoglobin less than 7.0g/dL; 6. Life expectance less than 5 years;

Design outcomes

Primary

MeasureTime frame
Progression-free Survival;

Secondary

MeasureTime frame
Overall survival;Cancer specific mortality;Disease-specific survival;To the time of occurrence of bone related events;To the time of castration resistant prostate cancer.;Compare health related quality of life;

Countries

China

Contacts

Public ContactFangjian Zhou

Sun Yat-sen University Cancer Center

zhoufj@sysucc.org.cn+86 02 87343312

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026