PROstate Cancer Imaging, Treatment and Toxicity (PROCITT)

This study is currently recruiting participants.
Verified June 2011 by Toowoomba Regional Cancer Research Centre
Sponsor:
Collaborator:
Abbott
Information provided by:
Toowoomba Regional Cancer Research Centre
ClinicalTrials.gov Identifier:
NCT01418040
First received: August 15, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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.

Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Toowoomba Regional Cancer Research Centre:

Primary Outcome Measures:
  • Prediction of ADT induced bone mineral density loss [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Feasibility, toxicity and efficacy of multimodality therapy with hypofractionated radiotherapy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Feasibility, toxicity (acute and late) and efficacy (5 year bNED by Phoenix definition) of multimodality therapy with hypofractionated radiotherapy

  • To correlate marrow changes on MR with changes in blood counts and patient reported fatigue [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    To correlate marrow changes on MR with changes in blood counts and patient reported fatigue

  • Prognostic value of circulating tumour cells [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Determine prevalence of CTCs in men with high risk prostate cancer and the prognostic significance of CTCs

  • Implementation of a risk adapted duration of neoadjuvant hormonal therapy [ Time Frame: 6 years ] [ Designated as safety issue: No ]

    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.

  • Implementation of a nomogram based radiotherapy target delineation algorithm [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
High risk prostate cancer
Histologically confirmed patients with high risk prostate cancer seen at Radiation Queensland Toowoomba.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418040

Contacts
Contact: Clare S Ientile 07 4614 5811 clare.butters@roq.net.au

Locations
Australia, Queensland
Radiation Oncology Queensland Recruiting
Toowoomba, Queensland, Australia, 4350
Contact: Jarad M Martin, FRANZCR    07 4614 5813    jarad.martin@roq.net.au   
Contact: Clare S Butters    07 4614 5811    clare.butters@roq.net.au   
Principal Investigator: Jarad M Martin, FRANZCR         
Sponsors and Collaborators
Toowoomba Regional Cancer Research Centre
Abbott
Investigators
Principal Investigator: Jarad M Martin, FRANZCR Radiation Oncology Queensland
  More Information

No publications provided

Responsible Party: Dr Jarad Martin, Toowoomba Regional Cancer Research Centre
ClinicalTrials.gov Identifier: NCT01418040     History of Changes
Other Study ID Numbers: IIS MET-10-0030
Study First Received: August 15, 2011
Last Updated: August 15, 2011
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014