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The efficacy of cytoreductive TURP with ADT compared with ADT alone in mHSPC patients: an open-labeled, randomized controlled phase II trial.

The efficacy of cytoreductive TURP with ADT compared with ADT alone in mHSPC patients: an open-labeled, randomized controlled phase II trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027430
Enrollment
Unknown
Registered
2019-11-13
Start date
2019-11-12
Completion date
Unknown
Last updated
2019-11-18

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

Conditions

Prostate Caner

Interventions

experimental group:TURP combined with ADT
controlled group:ADT

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male; 2. Aged >=18, = 2, endless urination, urine waiting, indwelling catheterization, cystotomy due to dysuria, Qmax 2 year2; 9. No prior local treatment to prostate and metastatic lesion; 10. The primary lesion of prostate could be treated by TURP without severe complications including death, incontinence, rectal injury and life-threatening bleeding; 11. Voluntary participation and informed consent signed; 12. Patients could be treated and followed up regularly.

Exclusion criteria

Exclusion criteria: 1. Prior treatment to primary lesion including radical prostatectomy, TURP, radiation therapy, cryoablation, HIFU, irreversible electroporation; 2. History of chemotherapy or ADT > 6 months; 3. Small cell carcinoma of the prostate; 4. Poor physical condition and intolerant to the treatment of primary lesion; 5. Unwilling to take the risks of complications brought by the treatment to primary lesion or metastatic lesion 6. History of other malignant tumors (excluding basal cell carcinoma or other tumors cured for over 5 years); 7. Other severe conditions; 8. Enrolled in other trials.

Design outcomes

Primary

MeasureTime frame
progression of primary lesion;Local symptom;

Secondary

MeasureTime frame
PSA progression;Overall survival;PSMA-based nuclear imaging;

Countries

China

Contacts

Public ContactDingwei Ye

Fudan University Shanghai Cancer Center

dwyeli_urp@163.com+86 021-64175590

Outcome results

None listed

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