Tumour TARGET Prostate Cancer

Official Title

Tumour Targeted Radiation Therapy for Patients With Localized Prostate Cancer

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 tumour 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 tumour 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 tumour on MRI. This guides therapy, allowing the radiation treatment to be targeted to the tumour 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 tumour nodule in prostate gland.

Trial Description

Primary Outcome:

• Determine rates of Local Control after standard targeted boost radiation therapy in patients with localized prostate cancer.

Secondary Outcome:

• Determine if high‐dose tumour‐targeted radiation therapy for localized prostate cancer can be integrated in a standard‐care workflow.
• Determine a methodology with appropriate uncertainty margins for Gross Tumour Volume boost
• Evaluate the spatial distribution of prostatic carcinoma at the time of repeat biopsy
• Compare dose to recurrent and non‐recurrent tumour nodules.
• Determine rates of toxicity with tumour‐targeted boost radiation therapy.
• Assess Quality of Life (QoL) outcomes after high‐dose tumour‐targeted boost therapy.
• Determine patient acceptance of combination of high dose rate and volumetric modulated arc therapy techniques
• Determine clinical outcomes by comparing integrated boost volumetric modulated arc therapy and a combination of high dose rate and volumetric modulated arc therapy techniques.
• Determine dosimetric outcomes by comparing integrated boost volumetric modulated arc therapy and a combination of high dose rate and volumetric modulated arc therapy techniques.

This is a prospective two arm phase 2 trial investigating the technical and clinical performance of tumour-targeted (rather than prostate targeted) radiation therapy. Cohort 1 (Control group): This group consists of patients who have had previous radiation. This group will not receive any active treatment but will have a biopsy at 3 years from the time they completed their radiation therapy. Patient in this group will also continue to have their PSA checked per standard practice Cohort 2 (Experimental group): Patients in this group will receive one of 2 treatment arms of their choice. In addition to the MRI-guided prostate biopsy at 3 years and regular standard of care PSA checks, this group will also complete a quality of life questionnaire and have regular imaging per standard practice. Both groups will be followed by the research team per protocol.

View this trial on ClinicalTrials.gov