Bladder Cancer, Prostate Cancer (Post Prostatectomy)
Conditions
Keywords
prostate cancer, bladder cancer, adaptive radiotherapy, post-prostatectomy, bladder-conserving treatment
Brief summary
The goal of this clinical trial is to learn if adaptive radiation boost works to treat genitourinary cancers, esp. in the context of prostate cancer patients with post-prostatectomy local relapse and bladder cancer patients with bladder-conserving treatment. It will also learn about the safety and efficacy of adaptive boost. The main questions it aims to answer are: Does adaptive boost lower the toxicities? Does adaptive boost maintain or improve the clinical efficacy? Participants will: Undergo adaptive boost on 1.5-Tesla MR-Linac Visit the clinic once every 2 weeks during RT, and every 3 months post-ART Keep a regular QOL questinnaire completion
Interventions
RADIATIONadaptive RT
Prostate cancer pts post-prostatectomy：95%PTVboost 7Gy/3.5Gy/2f，95%PTV 66Gy/2.0Gy/33f，w/o 95%PTVp 50Gy/2.0Gy/25f Bladder cancer pts with bladder-conserving txt：95%PGTV 18Gy/6.0Gy/3f，95%PTV 50Gy/2.0Gy/25f，w/o 95%PTVp 50Gy/2.0Gy/25f
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with newly diagnosed or metastatic/recurrent pathologically confirmed urological tumors, clinically assessed as suitable for adaptive radiotherapy; * Age ≥ 18 years; * ECOG performance status score 0-2; * No prior radiotherapy history within the current radiation field; * No contraindications for MRI scanning; * No contraindications for radiotherapy.
Exclusion criteria
* Patients with contraindications to radiotherapy; * Patients unable to tolerate MRI or with contraindications to MRI scanning.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute GU and GI toxicities as per NCI-CTC 5.0 criteria 3-months post RT | 3-months post-RT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local control | 2-year | local control |
| disease-free survival | 2-year | disease-free survival |
| Quality-of-Life, general | Baseline, 1-month post-RT, every 3 months till 2-years post-RT | general quality-of-life questionaaires as per EORTC QLQ-C30 |
| Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales | Baseline, 1-month post-RT, every 3 months till 2-years post-RT | GU quality-of-life questionaaires as per EORTC QLQ-NMIBC24 |
| Quality-of-Life, sexual scales | Baseline, 1-month post-RT, every 3 months till 2-years post-RT | quality-of-life questionaaires as per IIEF-5 |
| Late toxicities | 2-year | Late GU and GI toxicities as per RTOG scales |
Countries
China
Contacts
Primary ContactNing-Ning Lu, M.D.
Outcome results
None listed