Tumor TARGET Prostate Cancer

NCT01802242 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-03-18

No results posted yet for this study

Summary

Prostate cancer is common in males and may develop over the course of an individual's life. This cancer is often discovered at the time of routine physical examinations and/or blood work or on rectal examination. Once diagnosed, most patients do require some form of treatment so that the prostate cancer does not progress to cause damage and/or shortened lifespan. Occasionally, after patients receive treatment, the investigators have found that an area of cancer remains within the prostate. Those patients with a large area of cancer (i.e. seen on MRI image) appear to have a higher chance of remaining or recurrent prostate cancer even after standard treatment. Thus, the investigators believe that the area of the prostate gland occupied by a dense area of cancer may need more radiation therapy than normal to remain cancer free.

Standard therapy currently in place in North America: Currently patients who are diagnosed with prostate cancer have 3 common options: surgery, external beam radiation therapy (EBRT) alone or internal radiation (brachytherapy). Patients may or may not receive hormone therapy alongside the radiation depending on their physician's preference. For those who receive radiation therapy, the tumor typically receives the same dose as the rest of the prostate gland.

Findings to date: In the past few years the investigators have discovered that patients with a tumor large enough to be seen on MRI images (\>5mm) have a higher chance than normal of having cancer remain in the prostate, despite receiving treatment for their cancer 3 years earlier. Using new technology investigators can deliver radiation therapy after viewing the prostate tumor on MRI. This guides therapy, allowing the radiation treatment to be targeted to the tumor within the prostate. Based on this earlier success the investigators believe that they can now safely give a higher dose of radiation to specifically target the cancer within the prostate gland.

Reason for the study: The investigators would like to test this technology and expertise to give radiation to a higher than normal dose to the tumor nodule in prostate gland.

Conditions

Interventions

RADIATION

Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy

Patients in this group will receive one of 2 treatment arms of their choice: * Arm 1: VMAT delivery with integrated VMAT boost (IB-VMAT) GTV: 95Gy in 38fractions * Arm 2: HDR-boost followed by VMAT GTV: 10Gy HDR + 76Gy in 38 fractions VMAT

OTHER

No Active Treatment - completed Prior Radiation

Already had prior radiation treatment. MRI-guided prostate biopsy at 3 years and PSA per standard practice

Sponsors & Collaborators

  • Princess Margaret Hospital, Canada

    collaborator OTHER
  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Peter Chung, MB ChB · University Health Network, The Princess Margaret

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01802242 on ClinicalTrials.gov