Tumor TARGET Prostate Cancer (NCT01802242) | Clinical Trial Compass
CompletedNot Applicable
Tumor TARGET Prostate Cancer
Canada85 participantsStarted 2012-11-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histological evidence of prostate adenocarcinoma.
. Discrete intra-prostatic tumor that can be confidently visualized on MRI prior to radiotherapy (\>5mm maximum diameter but \<33% of prostate volume, biopsy confirmed from initial diagnosis or interventional Biopsy) )
. At least 18 years old
. ECOG performance status 0 or 1
. Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed (this does not include standard care laboratory tests or imaging studies).
. Patients will be one of the following risk groups prior to therapy:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine rates of Local Control after standard targeted boost radiotherapy in patients with localized prostate cancer.
. Risk of LN involvement \<30% (Roach formula = 2/3PSA(\[G-6\]x10))
. Patients who received 78Gy RT to the prostate gland 3-4.5 years prior to enrollment (Cohort 1 only)
Exclusion criteria
. Previous history of radiation therapy to the prostate (Cohort 2)
. Diagnosis of another cancer not being skin cancer within the last 5 years (Cohort 2)
. Patients weight as per MRI Technologist's discretion
. Patients with contraindications to MRI: this includes patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI determination. Exceptions will be allowed if deemed sage and appropriate by the MRI technologist.
. Severe claustrophobia
. Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding biopsy
. Current hormonal therapy (Cohort 1) or initiated \>2 weeks prior to enrollment (Cohort 2)
. Radiological evidence of regional or distant metastases (Cohort 2)