Testing the safety and feasibility of neoadjuvant radiotherapy followed by radical prostatectomy in men with pelvic lymph node-positive locally advanced prostate cancer

Testing the safety and feasibility of neoadjuvant radiotherapy followed by radical prostatectomy in men with pelvic lymph node-positive locally advanced prostate cancer -- A single-arm, single-center, open-label, dose-escalation study

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900022716

Enrollment

Unknown

Registered

2019-04-23

Start date

2019-05-01

Completion date

Unknown

Last updated

2020-08-31

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

Conditions

prostate cancer

Interventions

Case series:neoadjuvant radiotherapy followed by radical prostatectomy

Eligibility

Sex/Gender

Male

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Men aged below 75 years. 2. Men with a diagnosis of prostate adenocarcinoma confirmed by biopsy results. 3. Men diagnosed with pelvic lymph node-positive locally advanced prostate cancer using contrast-enhanced CT, MRI, bone scan and/or 68Ga-PSMA PET/CT (N1M0). 4. Men with an expected survival exceeding 5 years. 5. ECOG 0-1 6. The participant is well-informed of the current treatment options and the design of this trial; he/she is willing and able to give informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: A patient may not enter the study if ANY of the following applies: 1. Lymph node metastasis spreading beyond pelvic and retroperitoneal nodes; 2. Bone metastasis or distant organ metastasis; 3. Prior exposure to any treatment for prostate cancer, including radiotherapy, chemotherapy, hormone therapy, focal therapy, etc.; 4. Prior transurethral enucleation or resection of the prostate; 5. Any abdominal surgery performed within 3 months prior to enrollment; 6. A transrectal prostate biopsy performed within 2 weeks prior to enrollment; 7. Sustained use of anticoagulation and antiplatelet drugs; 8. Any other previous or current malignancies; 9. Disease 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; 10. Participation in other trials which are ongoing or have been completed within 3 months; 11. Any contraindications for radiation therapy or surgery.

Design outcomes

Primary

Measure	Time frame
early and late toxicity of radiotherapy;Maximal tolerable dose of radiotherapy;	—

Secondary

Measure	Time frame
post-operative urinary continence;prostate specific antigen(PSA) level;testosterone level;erectile function;quality of life;rates of positive surgical margin;	—

Countries

China

Contacts

Public ContactShancheng Ren

Department of Urology, Shanghai Changhai Hospital

renshancheng@gmail.com+86 13917793885

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026