A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer

Not Applicable

Withdrawn

• Conditions: Prostate Cancer; Bladder Cancer
• Interventions: Radiation: Adaptive Radiation Therapy

• Registration Number: NCT03909893
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Radical radiation therapy for prostate cancer is a common treatment that has shown to improve clinical outcomes in a post-operative setting. However, radiation therapy after surgery poses a greater risk for bladder and rectum injury for patients with prostate or bladder cancer. For prostate cancer patients, the risk is further amplified when pelvic nodes are part of the target irradiated volume. For bladder cancer patients, the risk of injury increases when more of the bladder is part of the target volume. Using an adaptive radiation therapy approach allows for correcting any shifts in the target volume. ART approach uses images from treatment to adapt the treatment plan. This study will use Adaptive Radiation Therapy for patients who receive pelvic nodal radiotherapy for either prostate or bladder cancer. Their treatment plans will adapted using MRI scans and CBCT scans taken during their first week of radiotherapy to account for any shifts in the target volume. The purpose of this study is to evaluate the feasibility of ART approach and its and on treatment plan quality metrics for pelvic radiotherapy. Acute and late toxicities will also be evaluated. 40 participants (minimum of 10 bladder cancer patients) will be enrolled. The participants will be followed for a period of 5 years post radiation therapy, during which they will have PSA as per standard practice, along with follow-up questionnaires (EPIC for prostate cancer patients and BUSS for bladder cancer patients).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Study Start: 2023-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy:

   • Clinical stage pT3, pT4, or pT2 with positive margin; OR,
   • any p-stage with persistently elevated post-operative PSA > 0.05ng/mL; OR,
   • a delayed rise in PSA post-operative

2. Histologic diagnosis of transitional cell carcinoma of the bladder with intact bladder and:

   • Clinical stage cT2, cT3, cT4, and N0 or N1

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Exclusion Criteria

1. Inflammatory bowel disease or other contraindications to radiotherapy.
2. Prior pelvic radiotherapy
3. Previous cytotoxic chemotherapy
4. Evidence of systemic metastases on imaging

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adaptive Radiation Therapy	Adaptive Radiation Therapy	-

Primary Outcome Measures

Name	Time	Method
Dosimetry	5 years	Difference in dose-volume irradiation of critical organs between original and adapted plan will be compared.

Secondary Outcome Measures

Name	Time	Method
Toxicity in Patients	Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy	To determine a preliminary measure of toxicity with this technique. CTCAE toxicity data will be described for this population.
Bladder Cancer Patients' Quality of Life Function	Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy	Bladder Utility Symptom Scale (BUSS) questionnaires will be scored and analyzed to determine QoL function. BUSS will be scored (1-100) as per standard criteria. Data will be analyzed as a continuous variable
Prostate Cancer Patients' Quality of Life Function	Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy	Expanded Prostate Cancer Index Composite (EPIC) questionnaires will be scored and analyzed to determine QoL function. EPIC will be scored (1-100) as per standard criteria. Data will be analyzed as a continuous variable
Biochemical Control in Prostate Patients	PSA will be done before Radiation Therapy, and at Month 3, Year 1, 3 and 5 after Radiation Therapy	For prostate patients, patients will be considered to have biochemical failure if the PSA has risen 2ng above nadir.
Local Control in Bladder Patients	5 years	Local control will be defined by an absence of clinically locally recurrent disease
Feasibility of the use of Fiducial markers for bladder RT: quality of target delineation using fiducial markers	5 years	Feasibility will be determined by analyzing the quality of target delineation using fiducial markers in bladder cancer patients.

Trial Locations

Locations (1)

University Health Network, Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada