Clinical trials – prostate cancer

Clinical trials - prostate cancer - open to new participants

The PC Project

Criteria for the selection and treatment of clinically localised prostate cancer.

The main objective of the prostate cancer (PC) project is to improve the understanding of prostate cancer by utilising known and newly-developed methods. In a broad collaboration between units, departments and institutes, the objective is to contribute to reducing illness and morbidity in patients with clinically localised disease.

A secondary objective of the PC project is to establish a clinical database to assist with the quality control of diagnostics, staging of prostate cancer, operation (radical prostatectomy), therapeutical side effects, life quality, time of any relapses of the disease (biochemical, radiological) and surviving prostate cancer.

All patients who undergo surgery for removal of the prostate gland (radical prostatectomy) have had the opportunity to participate in the PC project since 2002. Approx. 1,900 patients contributed to the PC biobank with blood- and urine samples as well as prostate tissue.

The PC project is being carried out in close collaboration with the Department of Molecular Medicine (MOMA) Read more here

Contact:
Project Biomedical Analyst Mette Emdal, tel: 3091 1197
Project Biomedical Analyst Derya Ayyeldez, tel: 2460 8292  

Primary responsibility: Professor, Consultant, DMSc, PhD Michael Borre

MDM

The overall objective of the project is to develop new non-invasive or minimally invasive molecular diagnostic methods to improve the detection/diagnosis of prostate cancer and better prediction of the future progression of the disease. The aim of such methods is to pave the way for a future reduction in overtreatment of prostate cancer.

We will therefore:


1) Systematically and prospectively collect blood-, urine- and prostate tissue samples from patients referred to a prostate biopsy – e.g. with a prior prostate MR scanning for either diagnosing prostate cancer, or in active surveillance with a known prostate cancer.


2) Register all relevant clinical, paraclinical and histopathological parameters for these patients, as well as following them prospectively. For example the result of scanning, initial/repeat prostate biopsies, response to any later treatment for prostate cancer, any disease progression or PSA increase, etc.


3) Analyse specific molecular/candidate markers (e.g. miRNA, mRNA, DNA, DNA methylation, protein) in urine, blood and/or prostate biopsy tissue from the above-named patients and compare all molecular findings with relevant clinical, paraclinical and histopathological parameters including biopsy findings (positive=malign, negative=non-malign), tumour stage, Gleason classification, PSA etc.

The ultimate goal is thus to develop a molecular diagnostic test which provides greater certainty than the existing methods in predicting which patients actually need a MR scan and/or prostate biopsy (initial/repeat), as well as which patients in fact have prostate cancer that requires treatment. The final development of such a test will however require further studies in new multicentre studies.

The project is carried out in close collaboration with MOMA and approx. 3,500 patients are expected to participate in the project.


Read more about the project here.

Primary responsibility: Professor, Consultant, DMSc, PhD Michael Borre

Funding: The Danish National Advanced Technology Foundation has granted DKK 12.8 million to the project “Improved Molecular diagnostics for prostate cancer”, of which DKK 3.76 million goes to Aarhus University Hospital. The project is also supported by the Innovation Fund Denmark/Nordforsk (DKK 4.8 million). Applications will be made for additional financial support for the project from other foundations.

CRPC

The overall objective of the project is to develop new non-invasive or minimally invasive molecular biomarkers to improve treatment of advanced prostate cancer and better predictability of the effect of the current secondary hormone/chemotherapy treatments in these patients.

These biomarkers will help guide us in relation to which patients should be offered chemotherapy and which patients would benefit from secondary hormone treatment as first choice for prostate cancer patients where the primary hormone treatment is no longer adequate.

In future, we will systematically collect blood- and urine samples from patients where the primary hormone treatment is no longer effective enough (the patient is diagnosed with castration-resistant prostate cancer (CRPC)). Furthermore, if possible up to four tissue samples will also be taken from the prostate at the beginning of secondary hormone treatment/chemotherapy.

We will look for molecular differences in the primary cancer tissue and compare this with the molecular differences in the blood/urine samples taken at the same time. These extra tissue samples are taken so we can gain more fundamental knowledge about the underlying molecular conditions in prostate cancer tissue during treatment with secondary hormone treatment and/or chemotherapy.

Contact
Project Biomedical Analyst Derya Ayyildez, tel: 24608292

Project Biomedical Analyst Mette Emdal, tel: 3091 1197  

Project responsibility: Professor, Consultant, DMSc, PhD Michael Borre

SPCG 15

For many years, patients with prostate cancer that has spread outside the prostate but which has not spread to the lymph nodes or bones, have been offered radiotherapy to remove the cancer.

SPCG 15 is a randomised controlled trial which compares whether treatment with surgical removal of the prostate (radical prostatectomy) with possible subsequent radiotherapy has a better effect on the disease than the traditional radiotherapy together with medicinal castration treatment.

The trial is carried out in collaboration with the Department of Oncology at AUH where Consultant Lise Bentzen has clinical responsibility.

It is possible to participate at a number of urology/cancer departments in Denmark.

The study is carried out in collaboration with SPCG (Scandinavian Prostate Cancer Group) and approx. 1,200 patients will participate in the trial at a number of departments around Scandinavia.

Description of the trial

Contact: Project nurse Birgit Kaa Bach tel: 30 91 55 82

Project responsibility: Specialty Registrar Morten Andersen tel: 30 91 55 88

What is a clinical trial?

In order to gain new knowledge about urological diseases and become better at treating them, it is important to carry out clinical research with patient participation.

Through clinical research we can be better to prevent, diagnose and treat urological diseases.

Patients who meet the Department of Urology either in the clinic or the ward may be asked whether they wish to participate in a clinical research trial.

The majority of clinical trials are carried out with a view to clarifying whether new treatment options are better or at least as good as the current standard treatments.

Other trials compare existing standard treatments to gain more knowledge about forms of treatment.

The Research Unit at the Department of Urology takes part in different clinical trials, including trials of new medicines.
The trials are most often international trials in which new medicines are tested in centres around the world.
The majority of clinical trials at the Research Unit at the Department of Urology focus on prostate cancer patients.
Do not hesitate to ask the staff if you are interested in finding out whether there is a trial that you or one of your relatives could benefit from participating in.

Each trial has special requirements for the test subjects who take part.
For this reason, a number of examinations are required to determine whether the patient can take part in the trial.
These examinations may be in the form of blood samples, scans, ECGs, etc.

Who can participate in clinical trials?

The test subjects who participate in clinical trials can comprise patients from the Department of Urology at the hospitals in Skejby, Horsens or Randers, although patients may also be referred from other urology departments.

If you have any questions about participation in a trial, you are welcome to contact the Research Unit at the Department of Urology .

Participation is voluntary
Participation in a clinical trial is entirely voluntary and will not affect the patient's treatment options during or after participation.
Information on the objective of the trial and what is involved in participation will be provided by the staff at the research unit.

You are welcome to bring a relative or good friend along to the information discussion and you have the right to take time to think things over before deciding.
If you wish to participate, the patient and staff from the Research Unit sign a declaration of intent and it is first here that the initial examinations begin in the trial.

Read about trial subjects' rights on the National Committee on Health Research Ethics’ website.

Clinical trials of medicines at the Research Unit at the Department of Urology

The Research Unit at the Department of Urology takes part in different clinical trials, including trials of new medicines.

The trials are most often international trials in which new medicines are tested in centres around the world.
The majority of clinical trials focus on prostate cancer patients.
Do not hesitate to ask the staff if you are interested in finding out whether there is a trial that you could benefit from participating in.

Each trial has special requirements of participating test subjects.
For this reason, a number of examinations are often required to determine whether you can take part in the trial.
These examinations may be in the form of blood samples, scans, ECGs, etc.

What is required to participate in a research project:

Participation in a research project is entirely voluntary.
You will be informed both in writing and orally about the objective of the project and what your participation will involve, if you choose to take part.

You are welcome to bring a relative or good friend along to the information discussion and you have the right to take time to think things over before deciding.
If you wish to participate, you and the staff from the Research Unit sign a declaration of intent and it is first here that the initial examinations begin in the project.
You can at any time withdraw your informed consent to participate in the project and withdraw from the research project.
Withdrawing your informed consent will not affect either your current or future treatment at the department.

The storage of information about you, including information about your blood samples and tissue, is done in accordance with the regulations laid down by the Danish Act on Processing of Personal Data and the Danish Health Act.
It is possible to request right of access to experimental protocols in accordance with the provisions of the Danish Access to Public Administration Files Act. That is to say, you can get access to see all the information regarding your participation in the trial, with the exception of those parts that contain trade secrets or confidential data about other people.
There is the possibility to complain and receive compensation in accordance with the regulations laid down in the Danish Act on the Right to Complain and Receive Compensation within the Health Service.
If an injury should occur during the trial, you can contact the Danish Patient Compensation Association at www.patienterstatningen.dk.

You can read about taking part in health science trials as a test subject as well as about your rights here (pdf).

PRIMA

Early and precise detection of prostate cancer in general practice with new biomarkers and multiparametric MRI scans (PRIMA)

The objective of this trial is to develop new, improved and more precise methods for early detection of prostate cancer. We will therefore test a promising new biomarker test (also called the Stockholm-3 test), which can assess a man’s risk of having prostate cancer with the help of an ordinary blood sample. The new biomarker test is based on a genetic test and analysis of proteins in the blood, and the result of the test can show either normal or increased risk of prostate cancer.

We wish to examine whether the new biomarker test is better and more precise than the PSA test in demonstrating prostate cancer that requires treatment. In the project, men with an increased risk according to the new biomarker test or with increased PSA test, will be offered an MR scan of their prostate. If the scan shows suspected prostate cancer requiring treatment, we will offer an MR-supervised tissue sampling (biopsy) from the prostate taken from precisely the tissue which shows changes. This method is more precise and gentler than the method which is ordinarily used for taking tissue samples from the prostrate, as fewer insertions are made in the prostate.

We expect that approx. 3,000 men will participate in the project over a two-year period and they will be recruited at general practitioners in the Aarhus area.

The trial is being carried out in close collaboration with the Department of Public Health, the Research Unit for General Practice and the departments of: X-Ray and Scanning, Urology and Molecular Medicine (MOMA) at AUH.

Contact:
Project Biomedical Analyst Mette Emdal, tel.: 3091 1197
Project Biomedical Analyst Derya Ayyeldez, tel: 2460 8292

Sponsor investigator at the Department of Urology: Professor, Consultant, DMSc, PhD Michael Borre tel.: 7845 2616

Sponsor investigator: Consultant, PhD Bodil Ginnerup, X-ray & Scanning tel.: 4046 5581

Clinical trials – Closed for new participants

Radicals

Patients who undergo a radical prostatectomy due to prostate cancer may subsequently experience uncertainty about whether the cancer has been completely removed from the body. In Aarhus, patients with increased PSA after surgery are often referred to supplementary radiotherapy at the Department of Oncology.

There is general disagreement about whether it is most effective to give supplementary radiotherapy shortly after the operation, or whether the effect is just as good or better when delaying the radiotherapy until the patient has a PSA increase as a sign of the relapse of the disease.

Radicals is a European randomised controlled trial which examines when the best effect is achieved by offering the patients supplementary radiotherapy and whether receiving hormone treatment in addition to the radiotherapy has an effect.

Description of the trial.

Oncological Consultant at Rigshospitalet Peter Meindahl is the head of the trial in Denmark.
The trial is ongoing but new test subjects are no longer required.

The trial is conducted in collaboration with: Department of Oncology, Aarhus University Hospital Sponsor Investigator: Consultant Simon Buus

Contact: Project Nurse Birgit Kaa Bach Tel: 7845 2637

Clinical responsibility at the Department of Urology: Professor, Consultant, DMSc, PhD Michael Borre

MOL PROS

The objective of Mol Pros is to investigate whether a blood sample test of hereditary variations (SNP) in the genome compared with a familiar cancer anamnesis will help to predict an individual lifetime risk of developing prostate cancer, and on the basis of this enable planning of an appropriate monitoring procedure.

We wish to demonstrate that it is possible - without compromising on safety - to be able to reduce the need for PSA testing and the taking of prostate samples in men with increased PSA and negative prostate biopsies, but who are found to have low normal risk for the development of prostate cancer.

We also wish to demonstrate that the risk test increases the quality of life compared to men who do not have this possibility, and to demonstrate that men with increased PSA and negative prostate biopsies tested with high risk of developing prostate cancer and the subsequent intensive treatment, will have the disease demonstrated faster and at an earlier stage compared to men who are not offered this opportunity.

The lifetime risk assessment for developing prostate cancer is based on the result of the SNP blood sample result and the family prostate cancer anamnesis.
In theory, a person with low normal risk can change status during the trial follow-up in cases where there is newly occurring prostate cancer among close relatives. In such cases, the control group will be similarly altered.

The Mol Pros project is being carried out in close collaboration with the Department of Molecular Medicine MOMA Read more here

440 patients are participating and it is no longer possible for new participants to join the trial.

Contact: Project Biomedical Analyst Mette Emdal, tel.: 7845 2647

Primary responsibility: Professor, Consultant, DMSc, PhD Michael Borre

Clinical trials - completed

FC Prostate

The objective of the FC Prostate Community project is to study whether football training in a football club (football fitness) compared with the current types of training, is able to keep men with prostate cancer physically active and improve quality of life, muscle mass and bone strength.

All men who have been diagnosed with prostate cancer are able to participate in FC Prostate Community.

Research suggests that regular physical activity can have a positive effect on men with prostate cancer, among other things on the development of the disease.
At the same time, previous studies have shown that physical training has a positive effect on muscle strength, muscle mass, fitness, physical function, fatigue and quality of life. However, the majority of research trials have so far primarily studied the effect of short-term training offered by hospitals, and we therefore lack knowledge about the efficacy of long-term training options outside of the hospital environment.

The project is structured as a randomised controlled trial, i.e. the participants draw lots on whether or not they are placed in the group which played football, or in a control group which was encouraged to be physically active.

The entire programme for participation in the project took place over a sixth month period.

The football training took place in Lyseng Sports Club and the training squad was not open for outsiders. An experienced football trainer from the club was responsible for all training sessions and had already completed a course specifically designed for this particular project.

Read about offers in Aarhus Municipality:

The project was launched on the initiative of Julie Midtgaard, who is also responsible for the trial.
The study is anchored in Rigshospitalet under the University Hospitals Center for Health Research. Danish Cancer Society The project won the e-Boks Sports Confederation of Denmark and DR P4’s Sports Award in 2016.

It is no longer possible for new participants to join the project, although FC Prostate is still offered to patients with prostate cancer. The training takes place twice weekly at Lyseng Sports Club and other locations around Denmark.

The results of the project have not yet been published.

Project responsibility: Professor, Consultant, DMSc, PhD Michael Borre

Funding: The project is financed by the Trygfonden Foundation and supported by DBU (Danish Football Union).

Read about FC Prostate on the DBU website (in Danish).

See the feature on football for cancer-stricken older men from TV2 Øst here.

Body and mind

Online mindfulness training to combat stress, anxiety and depression among cancer survivors.

The objective of the project is to develop and evaluate an internet-based psychological treatment of delayed psychological complications for cancer survivors.
To make “Mindfulness-based Cognitive Therapy” more accessible for cancer patients and survivors, we thus wish - in collaboration with the users - to develop and test an internet-delivered version of the method.

It is no longer possible for new participants to join the trial.

Contact: Project Nurse Helene Holm Pedersen tel. 7845 2638 or Project Nurse Birgit Kaa Bach tel.: 7845 2637

Clinical responsibility: Professor, Consultant, DMSc, PhD Michael Borre