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Testing the safety and feasibility of neoadjuvant radiotherapy followed by radical prostatectomy in men with prostate cancer and oligometastases to the bone

Testing the safety and feasibility of neoadjuvant radiotherapy followed by radical prostatectomy in men with prostate cancer and oligometastases to the bone: a single-arm, single-center, dose-escalation trial

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025743
Enrollment
Unknown
Registered
2019-09-07
Start date
2019-09-09
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

prostate cancer

Interventions

Sponsors

Department of Urology, Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Men aged 18 to 75 years; (2) Men with a diagnosis of prostate cancer confirmed by biopsy results; (3) Men with oligometastases (including lesions of the bone, or lymph nodes superior to the level of renal artery; number of lesions less than 5) detected by ECT, MRI or 68Ga PSMA PET/CT; (4) ECOG 0-1; (5) The participant is well-informed of the current treatment options and the design of this trial; he is willing and able to give informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1. Prior exposure to any treatment for prostate cancer, including radiotherapy, chemotherapy, hormone therapy, focal therapy, etc.; 2. Prior transurethral enucleation or resection of the prostate; 3. Patients who took any abdominal surgery in the past 3 months; 4. Patients who received transrectal prostate biopsy in the past 2 weeks; 5. Sustained use of anticoagulation and antiplatelet drugs; 6. Patients who are having other malignancies or an acute/severe infection; 7. Patients who are complicated by other severe systemic diseases which, in the judgment of the investigators, are likely to interfere with the treatment, assessment or compliance associated with this trial; patients who are not suitable for general anesthesia; 8. Patients who have contradictions to radiation therapy or surgery; 9. Participation in other trials which are ongoing or have been completed within 3 months; 10. Patients who are not willing to take robotic-assisted laparoscopic prostatectomy.

Design outcomes

Primary

MeasureTime frame
Early/late complications related to radiotherapy, perioperative complications related to surgery (operation time, intraoperative bleeding volume, conversion rate, intraoperative radiotherapy area fibrosis, perioperative complications, etc.);

Secondary

MeasureTime frame
Positive rate of incision margin, no recurrence time of Biochemistry after operation, urine control after operation, recovery rate of sexual function after operation, quality of life scale, OS, endocrine adverse reactions;Adverse events;

Countries

China

Contacts

Public ContactShancheng Ren

Department of Urology, Shanghai Changhai Hospital

xiaoyutian212@163.com+86 13917793885

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026