A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer (ARTGU)

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).

Study Overview

• Status: Withdrawn
• Conditions: Prostate Cancer; Bladder Cancer
• Intervention / Treatment: Radiation: Adaptive Radiation Therapy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Chung, MD; Phone Number: 6522 416-946-4501; Email: peter.chung@rmp.uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network, Princess Margaret Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adaptive Radiation Therapy	Radiation: Adaptive Radiation Therapy; Cone-beam CT images as well as MRI scans will be used to make any changes to the radiation treatment plan, part of the way through the treatment. Adaptation of treatment plans may allow smaller target volumes to be treated with higher doses, while minimizing the side effects to surrounding organs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosimetry	Difference in dose-volume irradiation of critical organs between original and adapted plan will be compared.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity in Patients	To determine a preliminary measure of toxicity with this technique. CTCAE toxicity data will be described for this population.	Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy
Bladder Cancer Patients' Quality of Life Function	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	Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy
Prostate Cancer Patients' Quality of Life Function	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	Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy
Biochemical Control in Prostate Patients	For prostate patients, patients will be considered to have biochemical failure if the PSA has risen 2ng above nadir.	PSA will be done before Radiation Therapy, and at Month 3, Year 1, 3 and 5 after Radiation Therapy
Local Control in Bladder Patients	Local control will be defined by an absence of clinically locally recurrent disease	5 years
Feasibility of the use of Fiducial markers for bladder RT: quality of target delineation using fiducial markers	Feasibility will be determined by analyzing the quality of target delineation using fiducial markers in bladder cancer patients.	5 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Peter Chung, MD, Princess Margaret Cancer Centre - University Health Network

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Radiation Therapy; Adaptive
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urogenital Neoplasms
• Other Study ID Numbers: 17-5929

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No