prostate cancer
Conditions
Interventions
Experimental group:CyberKnife radiotherapy for prostate cancer and adjacent seminal vesicles delivering 39 Gy/6 Fx, with a simultaneous integrated boost to 48 Gy/6 Fx targeting the tumor lesion identi
Control group:CyberKnife radiotherapy for prostate cancer and adjacent seminal vesicles delivering 39 Gy/6 Fx
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed prostate adenocarcinoma within the past 6 months; 2. Primary localized PCa (cN0 and cM0 on mpMRI and PSMA-PET); 3. PSMA-PET examination completed; 4. Good physical condition with an ECOG performance status of 0 or 1; 5. Age >= 18 years; 6. Expected survival >= 5 years; 7. Patient voluntarily participates, receives standard treatment prior to stereotactic body radiotherapy of the prostate, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Prostate neuroendocrine tumor; 2. Previous history of prostate surgery, prostate or pelvic radiotherapy, or local prostate treatment; 3. Time interval between the start of ADT and the initial mpMRI and PSMA-PET scans is greater than 1 month; 4. Radiologically suspicious or pathologically confirmed mpMRI and/or PSMA-PET lymph node involvement (cN), metastatic disease (cM) / cT4 lesions; 5. Bilateral hip prostheses or any implants that may cause extensive CT artifacts; 6. Medication contraindications for undergoing mpMRI/PSMA-PET scans; 7. Contraindications to radiotherapy, or deemed unsuitable for radiotherapy by a radiation oncologist and medical physicist; 8. New malignancies within the past 2 years, or previous malignancies expected to significantly affect 5-year survival; 9. Concurrent participation in other interventional clinical trials that may interfere with this study; 10. According to clinical assessment, anticoagulation therapy with warfarin or a bleeding tendency that poses a risk for fiducial marker implantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA-progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| local progression-free survival;distant metastasis-free survival;progression-free survival, PFS;overall survival;prostate cancer-specific survival;Toxicity and Adverse Events;Quality of Life (QoL); | — |
Countries
China
Contacts
Public ContactWang Xin; Zhu Huaguang
Huashan Hospital, Fudan University
Outcome results
None listed