Tumor TARGET Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01802242|
Recruitment Status : Active, not recruiting
First Posted : March 1, 2013
Last Update Posted : May 9, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy Other: No Active Treatment - completed Prior Radiation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tumor Targeted Radiotherapy for Patients With Localized Prostate Cancer|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
|Experimental: Active Radiation Treatment (Cohort 2)||
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:
Prior Radiation Treatment (Control Cohort)
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
Other: No Active Treatment - completed Prior Radiation
Already had prior radiation treatment. MRI-guided prostate biopsy at 3 years and PSA per standard practice
- Determine rates of Local Control after standard targeted boost radiotherapy in patients with localized prostate cancer. [ Time Frame: 5 years ]
- Determine if high-dose tumor-targeted radiotherapy for localized prostate cancer can be integrated in a standard-care workflow. [ Time Frame: 5 years ]
- Determine a methodology with appropriate uncertainty margins for Gross Tumour Volume boost [ Time Frame: 5 years ]
- Evaluate the spatial distribution of prostatic carcinoma at the time of repeat biopsy [ Time Frame: 5 years ]
- Compare dose to recurrent and non-recurrent tumor nodules. [ Time Frame: 5 years ]
- Determine rates of toxicity with tumor-targeted boost radiotherapy. [ Time Frame: 5 years ]
- Assess Quality of Life (QoL) outcomes after high-dose tumor-targeted boost therapy. [ Time Frame: 5 years ]
- Determine patient acceptance of combination of high dose rate and volumetric modulated arc therapy techniques [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 5 years ]
- Explore the predictive value of baseline and early response imaging biomarkers on Local Control. [ Time Frame: 5 years ]
- Bank tissue and biofluids for future exploration of the relationship between biopsy tissue/serum/urine and disease recurrence. [ Time Frame: 5 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
Inclusion Criteria [applicable to both Cohorts 1 (control) and Cohort 2 (Experimental) unless otherwise specified]:
- 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 with > 10-year life expectancy
- 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:
- Low-risk disease (Gleason 6 and PSA <10 and T1) AND >50% of biopsy cores involved with tumor
- Intermediate-risk disease (Gleason 7 or PSA 10-20 or T2)
- High-risk disease (Gleason >8 or T3 or PSA >20)
- 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 [applicable to both Cohorts 1 (control) and Cohort 2(Experimental) unless otherwise specified]:
- 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 weighing >136kgs (weight limit for the scanner tables)
- 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)
- Other urinary or medical conditions deemed by the PI or associates to make the patient ineligible for MRI-guided prostate biopsy
- Contraindications to the endorectal coil, surgically absent rectum, severe hemorrhoids or previous colorectal surgery
- Contraindications to conscious sedation
- Latex allergy
- History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE (Cohort 2)
- Other medical conditions deemed by the PI to make patient ineligible for study intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802242
|University Health Network, The Princess Margaret|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Peter Chung, MB ChB||University Health Network, The Princess Margaret|
|Responsible Party:||University Health Network, Toronto|
|Other Study ID Numbers:||
UHN REB 12-5015-C
|First Posted:||March 1, 2013 Key Record Dates|
|Last Update Posted:||May 9, 2023|
|Last Verified:||May 2023|
prostate cancer treatment
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases