Prostate cancer
Conditions
Interventions
experimental group:Implantable isolation balloon
Control group:Non-implantation of isolation balloon
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Males with T1-T3a stage prostate cancer; (2) Aged 18-80 years; (3) ECOG score of 0-1; (4) Able to cooperate and complete all study procedures; (5) No metal implants in the abdomen, pelvis, or joints, and able to tolerate MRI scans; (6) No contraindications for CT scans; (7) Able to understand the purpose of the trial, voluntarily participate, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who have previously received pelvic radiotherapy; (2) Patients whose target tumors have previously undergone radiotherapy, chemotherapy, or surgery; (3) Patients with a history of other malignant tumors; (4) Individuals requiring pelvic lymph node irradiation; (5) Those with lymph node and distant metastases (i.e., prostate cancer TNM staging not N0 and M0); (6) Subjects deemed to have contraindications for radiotherapy by the researcher; (7) Patients with a prostate volume greater than 80 cm³ before enrollment; (8) History of rectal or gastrointestinal surgery or inflammatory bowel disease (including ulcerative colitis and Crohn's disease); (9) Those with injection site infections; (10) Individuals known to be allergic to the ingredients of the experimental product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients who achieved a reduction of rV70 by =25% and =50% after implantation of the isolating balloon.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rectal rV50, rV60, rV65, rV80 values and the rate of decrease after implanting a spacer balloon;The success rate of isolation balloon implantation and whether it is easy to implant.;Success rate of minimally invasive removal of isolation balloons.;Positioning balloon thickness (isolation distance, uniformity) on CT+MR images.;Stability of the device: Inflate the balloon before each radiotherapy session, and determine the displacement and rotation of the balloon on the positioning CT images.; | — |
Countries
China
Contacts
Public Contacthongzhen li
Peking University First Hospital
Outcome results
None listed