Clinical trials of medicines for prostate cancer patients

Clinical trials for prostate cancer patients - open for new participants.

BraVac

BraVac "A randomized, placebo-controlled and double-blind phase 2 study with the use of RV001V for men with biochemical relapse after curative treatment of localised prostate cancer”.

BraVac is a randomised controlled trial intended for patients who have either had their prostate surgically removed or have received radiotherapy of the prostate due to prostate cancer and who now have increasing PSA but with no visible metastases in scans.

The trial studies the effect, safety and tolerability of an experimental vaccine against the spread (metastasis) of the prostate cancer disease.

The participants are divided into two equally numbered groups via the drawing of lots, with one of the groups receiving active medicine in the form of the vaccine RV001V and the other receiving a placebo.

Twelve vaccines/placebos are administered over a 13 month period and the participants are monitored using blood samples and scans.

The objective of the trial is to study whether the experimental vaccine can postpone the patient’s need for what is today referred to as standard treatment and thus also reduce the risk of the side effects associated with the treatment.

The experimental vaccine is directed towards recognising a marker called RhoC, which sits on the surface of cancer cells that can spread (metastasise). The trial also studies whether a vaccination programme med RV001 can reduce the development of the prostate-specific antigen (PSA) compared to the control group.

Link to description of the trial: https://clinicaltrials.gov/ct2/show/NCT04114825?term=RHOVAC-002&draw=1&rank=1

Professor, consultant Michael Borre heads the trial at the Department of Urology in Skejby, and it is possible to participate in the trial at a number of urology departments in Denmark.

The trial is conducted in collaboration with the company RhoVac.

Find out more:
Please contact:

Project Nurse Vibeke Laursen Tel.: 2477 8812
Project Nurse Birgit Kaa Bach Tel: 7845 2637

Primordium

Clinical trials – closed for new participants

Ipatential150 - ROCHE study

“A double-blind, placebo-controlled, multicentre, randomised phase III study assessing ipatasertib in combination with abiraterone and prednisone/prednisolone, compared to placebo plus abiraterone and prednisone/prednisolone, in adult male patients with asymptomatic or mildly symptomatic, previously untreated metastatic castration-resistant prostate cancer”.

Patients with prostate cancer which is treated either medicinally or with surgically castration may over time experience that PSA increases or that more metastases appear on scans as a sign that the disease is spreading. This is termed castration-resistance (CRPC).

This trial investigates whether ipatasertib, given together with the drug Zytiga (Abiraterone) and prednisolon, can provide longer protection against the development of resistance compared with Zytiga and prednisolon, which is one of the approved treatments for patients with castration resistance.

Ipatersatib works by attacking and inhibiting the protein mTOR which is necessary for the cancer cells to grow and spread.

Up to half of patients with castration-resistance do not have an optimally functioning cancer-inhibiting protein PTEN (phosphatase and tensin homolog).
It is believed that the protein is important for inhibiting the division of the cancer cells and preventing resistance developing before treatment.

In order to participate in the study, the patient must give permission for the biopsies from the prostate to be examined for the PTEN protein. This does not necessarily mean that new biopsies need to be taken, as the biopsies that were taken in connection with the diagnosis of the disease can often be used.

Description of the trial

Professor Michael Borre heads the trial in Denmark and it is also possible to participate in the trial at the Department of Cancer in Odense.

The trial is conducted in collaboration with the company ROCHE.

Find out more:
Please contact:

Project Nurse Birgit Kaa Bach Tel: 7845 2637

Project Nurse Helene Holm Pedersen tel.: 7845 2638

Embark - nmCRPC

Embark

Patients who have undergone radiotherapy or removal of their prostate due to prostate cancer may subsequently experience that PSA increases and that they are advised to begin medicinal treatment.
At present these patients are offered anti-androgen treatment.
Embark is a randomised controlled trial with three "arms". The trial investigates whether Enzalutamid treatment, Enzalutamid treatment together with medicinal castration or medicinal castration alone has the best effect.

Professor, Consultant Michael Borre heads the trial in Denmark and it is possible to participate in several urology departments in Denmark.

The trial is conducted in collaboration with the companies Medivation and Astellas Pharma A/S.

Description of the trial

Find out more:
Please contact:

Project Nurse Birgit Kaa Bach Tel: 7845 2637

Arches - mHSPC

Patients with prostate cancer which has spread to the bones, lymph nodes or the body’s soft tissue can be treated with surgical or medicinal castration.

Arches is a randomised controlled trial which compares whether treatment with Enzalutamid together with medical/surgical castration has a better effect on the disease than treatment with medical/surgical castration alone.

To be able to take part in the trial, you must not have been undergoing castration treatment for longer than three months.
However, if it has been decided that you should have chemotherapy, there may go up to six months from the start of the castration treatment before you can take part in the trial.

Professor, Consultant Michael Borre heads the trial in Denmark which takes place at several urology departments in Denmark.
It is no longer possible for new participants to join the trial.

The trial is carried out in collaboration with the companies Pfizer and Medivation.

Description of the trial

Find out more:
Please contact:

Project Nurse Helene Holm Pedersen tel.: 7845 2638

Project Nurse Birgit Kaa Bach Tel: 7845 2637

PROSPER nmCRPC

Patients with prostate cancer without metastases who have been treated with surgical- or medicinal castration over a period of time may experience that PSA increases as a sign that the treatment is no longer sufficient. There is currently no approved additional treatment for these patients.

PROSPER is a randomised controlled trial which compares whether castration treatment together with Enzalutamid has a better effect than castration treatment together with placebo on the prostate cancer.

Professor, Consultant Michael Borre heads the trial in Denmark and it has been possible to participate in several urology departments in Denmark.

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

The trial is conducted in collaboration with the companies Medivation and Astellas Pharma A/S.

Description of the trial

Find out more:
Please contact:

Project Nurse Birgit Kaa Bach Tel: 7845 2637

PLATO - MDV3100-10

PLATO (MDV3100-10): A double-blind, placebo-controlled, randomised phase IV trial to examine continued treatment with enzalutamide after progression in patients with chemotherapy naive castration-resistant prostate cancer.

Professor, Consultant Michael Borre heads the trial in Denmark and it has been possible to participate in several urology departments in Denmark.

The trial is carried out in collaboration with the pharmaceutical company Medivation.

Description of the trial:

If you want to know more:

Please contact Project Nurse Birgit Kaa Bach Tel.: 7845 2637

Clinical trials - completed

HERO

HERO "A multi-national, randomised, open-label, parallel group, phase III trial to evaluate the safety and efficacy of relugolix in men with advanced prostate cancer”.

Patients with prostate cancer which has spread to the bones, lymph nodes or the body’s soft tissue can be treated with surgical- or medicinal castration.
HERO is a randomised controlled trial intended for patients who are beginning castration treatment for hormone-sensitive prostate cancer.
The trial compares medicinal castration treatment in the form of the standard treatment of injection with Eligard (Leuporelin) given every third month with Relugolix, which is a tablet treatment (GNRH antagonist).

Relugolix is a new medicinal product which works by reducing the male hormone testosterone.
All participants are closely followed via testosterone measurements over a year.

Description of the trial

Professor, consultant Michael Borre heads the trial in Denmark.

Find out more:
Please contact:

Project Nurse Helene Holm Pedersen tel.: 7845 2638

Project Nurse Birgit Kaa Bach Tel: 7845 2637

PREMISE

PREMISE is a European observational study in which the effect and side effects of Enzalutamid treatment when given to patients in ordinary clinical practice are evaluated. Professor, Consultant Michael Borre heads the trial in Denmark and it is possible to participate in several urology departments in Denmark. The trial is conducted in collaboration with the companies Medivation and Astellas Pharma A/S.

Description of the study

Find out more:

Please contact:

Project Nurse Birgit Kaa Bach Tel: 7845 2637 or

Project Nurse Susanne Skou tel: 7845 2636

MDV3100 - Open label

A phase II, open, single-group effect and safety trial with MDV3100 in patients with hormone naive prostate cancer. Professor, Consultant Michael Borre heads the trial in Denmark and it has been possible to participate at several urology departments in Denmark. The trial is conducted in collaboration with the company Medivation. Description of the project: If you want to know more: Please contact Project Nurse Susanne Skou Jensen Tel.: 7845 2636

A phase II, open, single-group effect and safety trial with MDV3100 in patients with hormone naive prostate cancer.

Professor, Consultant Michael Borre heads the trial in Denmark and it has been possible to participate at several urology departments in Denmark.

The trial is conducted in collaboration with the company Medivation.

Project description:

If you want to know more:

Please contact Project Nurse Birgit Kaa Bach Tel.: 7845 2637

Terrain

TERRAIN -Open label: A double-blind, randomised phase II effect and safety trial with MDV3100 (ASP9785) versus Bicalutamid in castrated men with metastatic prostate cancer.

Professor, Consultant Michael Borre heads the trial in Denmark and it has been possible to participate at several urology departments in Denmark.

The trial is conducted in collaboration with the company Medivation.

Description of the study:

Article published in The Lancet Oncology:

Find out more:
Please contact Project Nurse Susanne Skou Jensen Tel.: 7845 2636

Prevail - open label

Prevail Open label (MDV3100-03) is a multinational phase 3, randomized, double-blind, placebo-controlled trial for the study of efficacy and safety of treatment with oral MDV3100 in patients with progressive metastatic prostate cancer, who have not previously received chemotherapy, and for whom androgen deprivation treatment has not worked.

Description of the trial:

Article published in The Lancet Oncology:

Professor, Consultant Michael Borre heads the trial in Denmark and it has been possible to participate in several urology departments in Denmark. The trial is carried out in collaboration with the pharmaceutical company Medivation.

Find out more:
Please contact Project Nurse Helene Holm Pedersen tel.: 7845 2638

PSA Erect - SPCG 14

A randomised, open, multicentre, 2-armed, Phase III trial with androgen deprivation +/-Taxotere (docetaxel) for patients with non-metastatic prostate cancer and an increasing PSA.

- in collaboration with Scandinavian Prostate Cancer Group.

Description of the study:

Find out more:

Please contact Project Nurse Birgit Kaa Bach Tel.: 7845 2637

Latitude

A randomised, double-blind, comparator study with abiraterone acetate plus low-dose prednisone plus androgen deprivation therapy (ADT) compared with ADT alone in newly-diagnosed test subjects with high-risk, metastatic prostate cancer, who have not previously been treated with hormones (mHNPC).

Professor, Consultant Michael Borre heads the trial in Denmark and it has been possible to participate at several urology departments in Denmark.

The trial is carried out in collaboration with the company Janssen-Cilag.

Description of the study:

Find out more:
Please contact Project Nurse Birgit Kaa Bach Tel.: 7845 2637

Prospect

A randomised, double-blind, phase III effect trial with PROSTVAC-V/F +/- GM-CSF for men with asymptomatic or minimally symptomatic metastatic and castration resistant prostate cancer.

Professor, Consultant Michael Borre heads the trial in Denmark and it has been possible to participate in several urology departments in Denmark.

The trial is carried out in collaboration with the pharmaceutical company BN Immuno Therapeutics.

Description of the trial:

Find out more:
Please contact Project Nurse Birgit Kaa Bach Tel.: 7845 2637

AD PRO - SPCG 12

An open, randomised phase III trial of six cycles of docetaxel versus monitoring after radical prostatectomy in prostate cancer patients with high grade pT3 or margin positive pT2.

The patients were followed over five years and the final patients finished their five-year monitoring in the summer of 2015.

The data is being processed and the results of the study are expected to be published soon.

Description of the trial:

The trial is carried out as part of the Scandinavian Prostate Cancer Group (SPCG) collaboration.

The trial was a collaboration between oncological and urological departments at multiple hospitals in the Nordic countries.

The sponsor investigator in Denmark was Consultant Lisa Sengeløv, Department of Oncology, Herlev Hospital and Professor Michael Borre, Department of Urology, Aarhus University

ZD 4054 - POST CHEMO

An open phase II safety trial at two experimental centres with one treatment group for the study of the peroral administration of 10 mg ZD4054 once daily in patients with metastatic, hormone-resistant prostate cancer who have previously received chemotherapy.

The sponsor investigator in Denmark was Michael Borre, Department of Urology, Aarhus University
The trial was conducted in collaboration with the Department of Urology, Rigshospitalet, Professor Peter Iversen

The trial was interrupted in the summer of 2010 when Astra Zeneca could not document longer survival in patients who received Zibotentan compared to patients who received a placebo in the large randomized studies.

Description of the trial:

Iceland

"Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with hormone responsive prostate cancer will be randomized and will receive either intermittent or continuous ELIGARD treatment for 36 months. Following this treatment period, subjects will enter a long-term follow-up period for 48 months."

The trial was conducted in collaboration with and sponsored by Astellas Pharma A/S.

Sponsor investigator in Denmark: Several centres in Denmark took part in the trial

Description of the trial:

Read the article here:

Zeus - SPCG 11

Prevention of bone metastases in patients with high-risk nonmetastatic prostate cancer treated with zoledronic acid: efficacy and safety results of the Zometa European Study (ZEUS).

Read the article here:

Tasquinimod/ABR-215050

A randomised, double-blind, placebo-controlled proof of concept study of maintenance therapy with TASQUINIMOD in patients with metastatic castrate-resistant prostate cancer who are not progressing after first line Docetaxel based chemotherapy

Description of the trial:

The trial was interrupted before time when interim analysis showed that Tasquinimod did not improve survival in relation to placebo.

The sponsor investigator in Denmark was Michael Borre, Department of Urology, Aarhus University.
A number of urology and oncology centres in Denmark participated in the study.

Enthuse 14

A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases (ENTHUSE M1)

Description of the trial:

Read the article

Denosumab

Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study

Description of the study:

Read the article

The sponsor investigator in Denmark was Michael Borre, Department of Urology, Aarhus University.
A number of urology centres in Denmark participated in the study.