Adaptive Radiotherapy for Genitourinary Cancers (SMART-B01)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Bladder Cancer; Prostate Cancer (Post Prostatectomy)

Treatments: Radiation: adaptive RT

Study type: Interventional

Funder types: Other

Identifiers

NCT07324798

NCC-020503

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Experimental arm

Experimental group

Description:

Pts will receive adaptive boost for clinically significant disease

Treatment:

Radiation: adaptive RT