A Study of Adaptive Radiation Therapy for Pelvic Genitour... | NCT03909893

Studies
A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer

NCT03909893

Sponsor

University Health Network, Toronto

Status

Withdrawn

Last Update Posted

Mar 19, 2024Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Prostate Cancer
Bladder Cancer

Interventions

Adaptive Radiation Therapy

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study is being closed. The protocol may be reviewed and consolidated under a new study currently in development.

Expanded Access Info

Start Date

Oct 2023Estimated

Primary Completion Date

Jan 2025Estimated

Completion Date

Jan 2025Estimated

First Submitted Date

May 14, 2018

First Submission Date that Met QC Criteria

Apr 8, 2019

First Posted Date

Apr 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2024

Last Update Posted Date

Mar 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adaptive Radiation Therapy	Experimental		Radiation: Adaptive Radiation Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Chung, MD	Princess Margaret Cancer Centre - University Health Network	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Health Network, Princess Margaret Hospital		Toronto	Ontario	M5G 2M9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

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