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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01418040
Registration number
NCT01418040
Ethics application status
Date submitted
15/08/2011
Date registered
16/08/2011
Titles & IDs
Public title
PROstate Cancer Imaging, Treatment and Toxicity (PROCITT)
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Scientific title
A Phase 2 Clinical Trial Exploring 3-Dimensional Imaging of Androgen Deprivation Induced Osteoporosis, Radiotherapy Hypofractionation and the Prognostic Significance of Micrometastatic Disease in Men With Prostate Cancer
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Secondary ID [1]
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IIS MET-10-0030
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Universal Trial Number (UTN)
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Trial acronym
PROCITT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
High risk prostate cancer - Histologically confirmed patients with high risk prostate cancer seen at Calvary Mater Newcastle.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Prediction of ADT induced bone mineral density loss
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Assessment method [1]
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That baseline MR and CT imaging of lumbar spine cortical bone, trabecular bone, marrow and fat fraction combined with clinical factors predicts which men are at greater risk of accelerated Androgen Deprivation Therapy (ADT) induced bone mineral density loss than baseline DEXA scanning alone.
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Timepoint [1]
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6 years
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Secondary outcome [1]
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Feasibility, toxicity and efficacy of multimodality therapy with hypofractionated radiotherapy
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Assessment method [1]
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Feasibility, toxicity (acute and late) and efficacy (5 year bNED by Phoenix definition) of multimodality therapy with hypofractionated radiotherapy
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Timepoint [1]
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5 years
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Secondary outcome [2]
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To correlate marrow changes on MR with changes in blood counts and patient reported fatigue
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Assessment method [2]
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To correlate marrow changes on MR with changes in blood counts and patient reported fatigue
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Timepoint [2]
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6 years
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Secondary outcome [3]
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Prognostic value of circulating tumour cells
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Assessment method [3]
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Determine prevalence of CTCs in men with high risk prostate cancer and the prognostic significance of CTCs
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Timepoint [3]
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6 years
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Secondary outcome [4]
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Implementation of a risk adapted duration of neoadjuvant hormonal therapy
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Assessment method [4]
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Radiotherapy to commence when the first of the following triggers occurs:\[44\]
* PSA\<0.5 ng/L
* PSA plateau: Defined as a decrease between 2 PSAs taken at least 10 weeks apart of greater than 50%. This definition includes no change, and any increase in PSA observed. For example, if the PSA decreased from 10 to 2 (ie 80%) between 3 and 6 months, the man should receive a further 3 months of neoadjuvant ADT. Conversely, if the PSA decreased from 5 to 3 (ie 40%) over the same time period, the man should commence radiotherapy.
* 9 months of ADT delivered.
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Timepoint [4]
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6 years
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Secondary outcome [5]
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Implementation of a nomogram based radiotherapy target delineation algorithm
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Assessment method [5]
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Nomograms have been constructed from large surgical PC cohorts to help define the risk of extracapsular extension, seminal vesicle involvement and lymph node involvement based on initial clinical parameters. Trying to treat all patients with the progressively larger treatment volumes required to include these areas would potentially increase toxicity without a high chance of improving efficacy. However, if a threshold risk level of 15-25% were required prior to including each elective target volume, we would aim to apply such treatments to patients most likely to benefit.
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Timepoint [5]
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6 years
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Eligibility
Key inclusion criteria
Inclusion Criteria
1. Patient capable of giving informed consent
2. Histological diagnosis of prostate cancer
3. High risk disease defined by any one of:
1. Baseline PSA>20
2. Gleason grade 8 disease
3. Clinical stage T3-T4
4. Negative conventional staging in the form of a:
1. T99m whole body bone scan
2. CT of the abdomen and pelvis
5. No previous pelvic radiotherapy
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Minimum age
No limit
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
1. History of prior malignancy within the last 5 years with the exception of non-melanomatous skin cancers.
2. ECOG performance status >1
3. Inability to have intraprostatic fiducials inserted.
4. Inability to be given an MRI due to:
1. Implanted magnetic metal eg intraocular metal
2. Pacemaker / Implantable defibrillator
3. Extreme claustrophobia
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/11/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/07/2017
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Sample size
Target
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Accrual to date
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Final
28
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Calvary Mater Newcastle - Waratah
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Recruitment postcode(s) [1]
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2305 - Waratah
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Funding & Sponsors
Primary sponsor type
Other
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Name
Calvary Mater Newcastle, Australia
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Abbott
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a single centre prospective observational noninterventional study of men with histological confirmed prostate cancer, high risk disease and not positive for metastatic disease planned to receive Radiotherapy and 18 months of Androgen Deprivation Therapy (ADT). Although ADT improves the chance of cure, it can also have many side effects. One of these is bone mineral density loss. When this is advanced, it is called osteoporosis. Men with osteoporosis have a higher chance of getting fractures of bones such as the hip and spine. Currently, the best way to measure for osteoporosis is to do a bone mineral density scan using a DEXA scanner. The primary objective of this study is to see if baseline Magnetic Resonance Imager (MRI) and a Computer Tomogram (CT) combined with clinical factors predicts which men are at greater risk of accelerated ADT induced bone mineral density loss than baseline DEXA scanning alone. The data from the patients will be used to construct a model predicting annual rate of bone loss based on baseline imaging, clinical and biochemical characteristics. Secondary aims for this study are as follows: * Evaluating the feasibility, toxicity (acute and late) and efficacy (5 year biochemical control by the Phoenix definition)of multimodality therapy with hypofractionated radiotherapy (giving a larger dose of radiotherapy over a shorter time 5½ weeks compared with a standard 8 week approach). Although used overseas, this 5½ week regimen has not been used widely in Australia, and we would like to see if we gain similar results here as have been reported from the US. * Feasibility and efficacy of a risk adapted duration of neoadjuvant hormonal therapy. Usually, ADT is given for between 19 months before radiotherapy is started but there is no agreement as to which duration is best. This trial aims to tailor the duration of ADT prior to radiotherapy based on blood PSA test results. * Prognostic value of circulating tumour cells (CTCs). This is a blood test which can detect cancer cells in the blood which has been used for patients with metastatic cancer. The presence of CTCs in men with prostate cancer correlated with poorer overall survival. Potentially, high risk prostate cancer patients with CTCs detected may represent a very high risk group and could therefore warrant treatment intensification. * To correlate bone marrow changes on MRI with changes in blood counts and patient reported fatigue. Measuring bone marrow may help in predicting not just which patients are at risk of losing bone faster but also of becoming anaemic, and suffering fatigue. A correlation may better explain some of the toxicities associated with ADT. * Implementation of a nomogram based radiotherapy target delineation algorithm. This trial aims to use a decision making tool called a nomogram to help tailor the area to treat in a more standard way.
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Trial website
https://clinicaltrials.gov/study/NCT01418040
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Trial related presentations / publications
Wu R, Woodford H, Capp A, Hunter P, Cowin G, Tai KH, Nguyen PL, Chong P, Martin J. A prospective study of nomogram-based adaptation of prostate radiotherapy target volumes. Radiat Oncol. 2015 Nov 25;10:243. doi: 10.1186/s13014-015-0545-y.
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Public notes
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Contacts
Principal investigator
Name
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Jarad M Martin, FRANZCR
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Address
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Calvary Mater Newcastle
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
It is not intended that results relating to a specific participant be reported to anyone other than the participant.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01418040