NCT01418040: PROCITT

PROstate Cancer Imaging, Treatment and Toxicity (PROCITT)

Completed Last updated 5 February 2018

What this trial tests

trial in Prostate Cancer in 28 participants. Completed in 20 July 2017.

Timeline

28 November 2012

Primary endpoint
20 July 2017

20 July 2017

Quick facts

Lead sponsor	Calvary Mater Newcastle, Australia
Status	Completed
Study type	OBSERVATIONAL
Enrollment	28
Start date	28 November 2012
Primary completion	20 July 2017
Estimated completion	20 July 2017
Sites	1 location across Australia

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Calvary Mater Newcastle, Australia

Who can join

Eligibility, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Circulating tumor cell detection in high-risk non-metastatic prostate cancer.
   Loh J, Jovanovic L, Lehman M, Capp A, et al · · 2014 · cited 50× · PMID 25028119 · DOI 10.1007/s00432-014-1775-3
2. A prospective study of nomogram-based adaptation of prostate radiotherapy target volumes.
   Wu R, Woodford H, Capp A, Hunter P, et al · · 2015 · cited 4× · PMID 26607977 · DOI 10.1186/s13014-015-0545-y