A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer

NCT03909893 | Withdrawn

• 1 other identifier: 17-5929
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer; Bladder Cancer

Keywords

Adaptive; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Dosimetry

  Difference in dose-volume irradiation of critical organs between original and adapted plan will be compared.

  5 years

Secondary Outcomes (6)

• Toxicity in Patients

  Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy

• Bladder Cancer Patients' Quality of Life Function

  Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy

• Prostate Cancer Patients' Quality of Life Function

  Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy

• Biochemical Control in Prostate Patients

  PSA will be done before Radiation Therapy, and at Month 3, Year 1, 3 and 5 after Radiation Therapy

• Local Control in Bladder Patients

  5 years

Study Arms (1)

Adaptive Radiation Therapy

EXPERIMENTAL

Radiation: Adaptive Radiation Therapy

Interventions

Adaptive Radiation Therapy RADIATION

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.

Adaptive Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Histologic diagnosis of transitional cell carcinoma of the bladder with intact bladder and:
• Clinical stage cT2, cT3, cT4, and N0 or N1

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

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

Study Officials

• Peter Chung, MD

  Princess Margaret Cancer Centre - University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: April 10, 2019
• Study Start: October 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

CA (1)