- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01802242
Tumor TARGET Prostate Cancer
Tumor Targeted Radiotherapy for Patients With Localized Prostate Cancer
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- University Health Network, The Princess Margaret
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Radiation Treatment (Cohort 2)
|
Patients in this group will receive one of 2 treatment arms of their choice:
|
Other: 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
|
Already had prior radiation treatment.
MRI-guided prostate biopsy at 3 years and PSA per standard practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine rates of Local Control after standard targeted boost radiotherapy in patients with localized prostate cancer.
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine if high-dose tumor-targeted radiotherapy for localized prostate cancer can be integrated in a standard-care workflow.
Time Frame: 5 years
|
5 years
|
Determine a methodology with appropriate uncertainty margins for Gross Tumour Volume boost
Time Frame: 5 years
|
5 years
|
Evaluate the spatial distribution of prostatic carcinoma at the time of repeat biopsy
Time Frame: 5 years
|
5 years
|
Compare dose to recurrent and non-recurrent tumor nodules.
Time Frame: 5 years
|
5 years
|
Determine rates of toxicity with tumor-targeted boost radiotherapy.
Time Frame: 5 years
|
5 years
|
Assess Quality of Life (QoL) outcomes after high-dose tumor-targeted boost therapy.
Time Frame: 5 years
|
5 years
|
Determine patient acceptance of combination of high dose rate and volumetric modulated arc therapy techniques
Time Frame: 5 years
|
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
|
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
|
5 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Explore the predictive value of baseline and early response imaging biomarkers on Local Control.
Time Frame: 5 years
|
5 years
|
Bank tissue and biofluids for future exploration of the relationship between biopsy tissue/serum/urine and disease recurrence.
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Peter Chung, MB ChB, University Health Network, The Princess Margaret
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN REB 12-5015-C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy
-
University of Maryland, BaltimoreCompletedHead and Neck Cancer | Oropharyngeal Squamous Cell Carcinoma | Oropharynx CancerUnited States
-
Umeå UniversityRegion VästerbottenRecruitingAnal Cancer Squamous CellSweden
-
HCA International LimitedTerminatedMetastatic Brain CancerUnited Kingdom
-
National Institute of CancerologíaActive, not recruitingGynecologic CancerMexico
-
Centre hospitalier de l'Université de Montréal...CompletedQuality of Life | Pain | Neoplasm Metastasis | Radiotherapy Side Effect
-
Leiden University Medical CenterErasmus Medical Center; HollandPTCRecruitingUterine Cervical Neoplasms | Locally Advanced Cervical CarcinomaNetherlands
-
Fundacao ChampalimaudRecruitingProstate CancerPortugal
-
British Columbia Cancer AgencyActive, not recruiting
-
Lawson Health Research InstituteAcademic Medical Organization of Southwestern OntarioRecruiting
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Recruiting