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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)

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]

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

Condition category

Condition code

Cancer

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]

Prediction of ADT induced bone mineral density loss

Timepoint [1]

6 years

Secondary outcome [1]

Feasibility, toxicity and efficacy of multimodality therapy with hypofractionated radiotherapy

Timepoint [1]

5 years

Secondary outcome [2]

To correlate marrow changes on MR with changes in blood counts and patient reported fatigue

Timepoint [2]

6 years

Secondary outcome [3]

Prognostic value of circulating tumour cells

Timepoint [3]

6 years

Secondary outcome [4]

Implementation of a risk adapted duration of neoadjuvant hormonal therapy

Timepoint [4]

6 years

Secondary outcome [5]

Implementation of a nomogram based radiotherapy target delineation algorithm

Timepoint [5]

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?

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

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Calvary Mater Newcastle - Waratah

Recruitment postcode(s) [1]

2305 - Waratah

Funding & Sponsors

Primary sponsor type

Other

Name

Calvary Mater Newcastle, Australia

Address

Country

Other collaborator category [1]

Commercial sector/industry

Name [1]

Abbott

Address [1]

Country [1]

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

Jarad M Martin, FRANZCR

Address

Calvary Mater Newcastle

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01418040