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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 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.
Timepoint [1] 0 0
6 years
Secondary outcome [1] 0 0
Feasibility, toxicity and efficacy of multimodality therapy with hypofractionated radiotherapy - Feasibility, toxicity (acute and late) and efficacy (5 year bNED by Phoenix definition) 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 - 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 - Determine prevalence of CTCs in men with high risk prostate cancer and the prognostic significance of CTCs
Timepoint [3] 0 0
6 years
Secondary outcome [4] 0 0
Implementation of a risk adapted duration of neoadjuvant hormonal therapy - 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.
Timepoint [4] 0 0
6 years
Secondary outcome [5] 0 0
Implementation of a nomogram based radiotherapy target delineation algorithm - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/NCT01418040
Trial related presentations / publications
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
Other publications