PROstate Cancer Imaging, Treatment and Toxicity (PROCITT)

NCT01418040 | Completed DMC

• 1 other identifier: IIS MET-10-0030
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  6 years

Secondary Outcomes (5)

• Feasibility, toxicity and efficacy of multimodality therapy with hypofractionated radiotherapy

  5 years

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

  6 years

• Prognostic value of circulating tumour cells

  6 years

• Implementation of a risk adapted duration of neoadjuvant hormonal therapy

  6 years

• Implementation of a nomogram based radiotherapy target delineation algorithm

  6 years

Study Arms (1)

High risk prostate cancer

Histologically confirmed patients with high risk prostate cancer seen at Calvary Mater Newcastle.

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from Radiation Oncology Queensland Toowoomba outpatient clinics will be offered recruitment into the study by Radiation Oncologists.

You may qualify if:

• Patient capable of giving informed consent
• Histological diagnosis of prostate cancer
• High risk disease defined by any one of:
• Baseline PSA\>20
• Gleason grade 8 disease
• Clinical stage T3-T4
• Negative conventional staging in the form of a:
• T99m whole body bone scan
• CT of the abdomen and pelvis
• No previous pelvic radiotherapy

You may not qualify if:

• History of prior malignancy within the last 5 years with the exception of non-melanomatous skin cancers.
• ECOG performance status \>1
• Inability to have intraprostatic fiducials inserted.
• Inability to be given an MRI due to:
• Implanted magnetic metal eg intraocular metal
• Pacemaker / Implantable defibrillator
• Extreme claustrophobia

Sponsors & Collaborators

• Calvary Mater Newcastle, Australia: lead
• Abbott: collaborator

Study Sites (1)

Calvary Mater Newcastle

Waratah, New South Wales, 2305, Australia

Location

Related Publications (1)

• 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.

  PMID: 26607977 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jarad M Martin, FRANZCR

  Calvary Mater Newcastle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Jarad Martin

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 16, 2011
• Study Start: November 28, 2012
• Primary Completion: July 20, 2017
• Study Completion: July 20, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)