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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
Date last updated
5/02/2018

Titles & IDs
Public title
PROstate Cancer Imaging, Treatment and Toxicity (PROCITT)
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
Secondary ID [1] 0 0
IIS MET-10-0030
Universal Trial Number (UTN)
Trial acronym
PROCITT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
High risk prostate cancer - Histologically confirmed patients with high risk prostate cancer seen at Calvary Mater Newcastle.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prediction of ADT induced bone mineral density loss
Timepoint [1] 0 0
6 years
Secondary outcome [1] 0 0
Feasibility, toxicity and efficacy of multimodality therapy with hypofractionated radiotherapy
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
To correlate marrow changes on MR with changes in blood counts and patient reported fatigue
Timepoint [2] 0 0
6 years
Secondary outcome [3] 0 0
Prognostic value of circulating tumour cells
Timepoint [3] 0 0
6 years
Secondary outcome [4] 0 0
Implementation of a risk adapted duration of neoadjuvant hormonal therapy
Timepoint [4] 0 0
6 years
Secondary outcome [5] 0 0
Implementation of a nomogram based radiotherapy target delineation algorithm
Timepoint [5] 0 0
6 years

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
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/07/2017
Sample size
Target
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 0 0
2305 - Waratah

Funding & Sponsors
Primary sponsor type
Other
Name
Calvary Mater Newcastle, Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Abbott
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01418040
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.
Public notes

Contacts
Principal investigator
Name 0 0
Jarad M Martin, FRANZCR
Address 0 0
Calvary Mater Newcastle
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01418040