Adaptive Radiotherapy for Genitourinary Cancers

NCT07324798 | Recruiting DMC

• 1 other identifier: NCC-020503
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer (Post Prostatectomy); Bladder Cancer

Keywords

prostate cancer; bladder cancer; adaptive radiotherapy; post-prostatectomy; bladder-conserving treatment

Outcome Measures

Primary Outcomes (1)

• Acute GU and GI toxicities as per NCI-CTC 5.0 criteria 3-months post RT

  3-months post-RT

Secondary Outcomes (11)

• Quality-of-Life, general

  Baseline, 1-month post-RT, every 3 months till 2-years post-RT

• Local control

  2-year

• disease-free survival

  2-year

• Late toxicities

  2-year

• Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales

  Baseline, 1-month post-RT, every 3 months till 2-years post-RT

Study Arms (1)

Experimental arm

EXPERIMENTAL

Pts will receive adaptive boost for clinically significant disease

Radiation: adaptive RT

Interventions

adaptive RT RADIATION

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

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with contraindications to radiotherapy;
• Patients unable to tolerate MRI or with contraindications to MRI scanning.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, National Cancer Center, CAMS & PUMC

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases

Central Study Contacts

Ning-Ning Lu, M.D.

CONTACT

861018611804268; ningninglu09@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 7, 2026
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-12

Locations

CN (1)