Tumor TARGET Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) RadiotherapyOther: No Active Treatment - completed Prior Radiation
- Registration Number
- NCT01802242
- Lead Sponsor
- University Health Network, Toronto
- Brief 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.
- Detailed Description
This is a prospective two arm phase 2 trial investigating the technical and clinical performance of tumor-targeted (rather than prostate targeted) radiotherapy.
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 85
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Radiation Treatment (Cohort 2) Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy - Prior Radiation Treatment (Control Cohort) No Active Treatment - completed Prior Radiation Patients who received 78Gy RT to the prostate gland 3-4.5 years prior to enrollment. This group will not be receiving any active treatment
- Primary Outcome Measures
Name Time Method Determine rates of Local Control after standard targeted boost radiotherapy in patients with localized prostate cancer. 5 years
- Secondary Outcome Measures
Name Time Method Determine if high-dose tumor-targeted radiotherapy for localized prostate cancer can be integrated in a standard-care workflow. 5 years Compare dose to recurrent and non-recurrent tumor nodules. 5 years Determine patient acceptance of combination of high dose rate and volumetric modulated arc therapy techniques 5 years Determine a methodology with appropriate uncertainty margins for Gross Tumour Volume boost 5 years Evaluate the spatial distribution of prostatic carcinoma at the time of repeat biopsy 5 years Determine clinical outcomes by comparing integrated boost volumetric modulated arc therapy and a combination of high dose rate and volumetric modulated arc therapy techniques. 5 years Determine dosimetric outcomes by comparing integrated boost volumetric modulated arc therapy and a combination of high dose rate and volumetric modulated arc therapy techniques. 5 years Determine rates of toxicity with tumor-targeted boost radiotherapy. 5 years Assess Quality of Life (QoL) outcomes after high-dose tumor-targeted boost therapy. 5 years
Trial Locations
- Locations (1)
University Health Network, The Princess Margaret
🇨🇦Toronto, Ontario, Canada