Prostate CancerPhase 2ARNEONCT03080116
Neoadjuvant Degarelix With or Without Apalutamide (ARN-509) Followed by Radical Prostatectomy
A Phase 2 study testing ARN-509 and Degarelix in people with Prostate Cancer and Neoadjuvant Therapy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
RATIONALE: Neoadjuvant hormonal therapy using luteinizing hormone releasing hormone (LHRH) agonists and/or anti-androgens has already demonstrated to downstage primary prostate cancer in patients treated by radical prostatectomy without a survival benefit. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Neoadjuvant Therapy, Androgen Antagonists
- What is being tested?
- ARN-509 and Degarelix
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Mar 2019to 1 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
- Male aged 18 years or older (within 80 years)
- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
- Diagnosis of intermediate (at least 2 of the following factors: cT2b, biopsy GS 7, PSA 10-20ng/ml) or high-risk prostatic adenocarcinoma (clinical stage≥T2c and/or biopsy GS≥8 and/or PSA>20ng/ml), cN0-cN1, cM0.
- Patient amenable for open or robotic radical prostatectomy + pelvic lymph node dissection
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- ECOG performance status: 0-1
- Adequate organ function as defined by the following criteria:
- White blood cells (WBC) ≥ 4.0 x109/L
- Platelet count ≥ 100 x109/L
- Hemoglobin ≥9 g/dl
- Creatinine ≤ 2 x ULN
- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x upper limit of normality (ULN)
- Total serum bilirubin ≤1.5 x ULN.
Who cannot join
- Previous surgical/endoscopic treatments for prostatic disease
- Herbal and non-herbal products that in the opinion of the investigator may decrease PSA levels
- cM1 disease
- Any contraindication for PET or MR investigations
- History of seizure or condition that may pre-dispose to seizure (e.g., prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
- Medications known to lower the seizure threshold
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- History of:
- Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer currently in complete remission) within 5 years prior to randomization
- Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
- Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic BP ≥100 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
- Gastrointestinal disorder affecting absorption
- Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Degarelix +/- Apalutamide (ARN-509) Followed by Radical Prostatectomy for Intermediate and High-risk Prostate Cancer: a Randomized, Placebo-controlled Trial
RATIONALE: Neoadjuvant hormonal therapy using luteinizing hormone releasing hormone (LHRH) agonists and/or anti-androgens has already demonstrated to downstage primary prostate cancer in patients treated by radical prostatectomy without a survival benefit. There is no evidence yet of a survival impact of LHRH antagonist (LHRHa) +/- new-generation anti-androgens in this setting. Thus novel studies are needed to assess this treatment combination.
PURPOSE: To assess the difference in treatment antitumor effect between arms by measuring pathological tumor volume with minimal residual disease (MRD) following radical prostatectomy + pelvic lymph-node dissection (RP + PLND) for intermediate or high-risk prostate cancer patients.
Read the detailed description
PRIMARY OBJECTIVE: To assess the difference in antitumor effect between the treatment arms by measuring MRD following radical prostatectomy.
SECONDARY OBJECTIVES: To measure differences between study arms in
- Proportions of post neoadjuvant prostate specific antigen (PSA) ≤ 0.3 ng/ml as a predictor of prostate cancer mortality
- T down-staging, complete pathological response, PSA kinetics, Testosterone kinetics, operation time, blood loss, grade of surgical difficulty
- New generation hybrid imaging 68Ga PSMA (Prostate-Specific Membrane Antigen) PET/MR (Positron emission tomography/Magnetic Resonance) derived parameters
- Early biochemical recurrence as prognostic factor of prostate cancer mortality
- Transcriptome and genome
- Tissue microarrays (TMA) protein expression (DNA repair, resistance etc.) by immunohistochemistry
- Perioperative safety and tolerability
- Quality of life, erection recovery, continence through validated preoperative and postoperative questionnaires pre and postop (IEEF5, ICIQ, EORTC QLQ-C30)
OUTLINE: interventional, single center, phase II, randomized, double blind, placebo controlled trial.
- Being tested
- ARN-509, Degarelix, Placebo
- Keywords
- Randomized, Placebo-controlled, Neoadjuvant, Androgen deprivation, Antiandrogen, Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARN-509Drug
Also called apalutamide
240mg/day (4x60mg tablets, Oral administration: OS)
DegarelixDrug
1st injection: 120mg Subcutaneous administration (SC) x2, 2nd-3rd SC injection 80mg monthly
PlaceboOther
4 tablets, per OS
| Study group | Role | What they receive |
|---|---|---|
| ARN-509 + degarelix | Experimental | Treatment period of 12 weeks before RP + PLND. Receives: Drug: ARN-509; Drug: Degarelix |
| placebo + degarelix | Active comparator | Treatment period of 12 weeks before RP + PLND. Receives: Drug: Degarelix; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal Residual Disease (MRD)
Proportions of MRD between arms. MRD: tumor volume ≤ 0.25 cm3
Measured: After 12 weeks of neoadjuvant therapy + RP + PLND
Secondary outcomes (26)
Difference in proportions of pathological downstage
Any decrease in T stage from clinical to pathological stage
Measured: After 12 weeks of neoadjuvant therapy + RP + PLND
Complete pathological response rates
Difference in proportions of complete pathological response (no evidence of tumour in the postoperative specimen) between arms.
Measured: After 12 weeks of neoadjuvant therapy + RP + PLND
Difference in proportions of patients with pN1 disease.
Difference in proportions of lymph node invasion between arms
Measured: After 12 weeks of neoadjuvant therapy + RP + PLND
Proteins expression in prostatic tumour TMA's (tissue microarrays)
Intensity of immunoreactivity and percentage of immunoreactive cells for, selected markers between arms. The TMA's will be produced from the formalin-fixed paraffin-embedded (FFPE) specimen of the RP.
Measured: After 12 weeks of neoadjuvant therapy + RP + PLND
Transcriptome analysis by microarray expression platform
To assess differences in the transcriptome in tumour tissue on formalin-fixed paraffin-embedded (FFPE) specimens: clinical-grade high-density oligonucleotide microarray expression platform and cloud-based informatics pipeline to interrogate 1.4M probe sets representing all known ~46K genes and non-coding RNAs.
Measured: At baseline and after 12 weeks of neoadjuvant therapy + RP + PLND
Pathway profiling and Gene Set Enrichment Analyses
To assess differences in the transcriptome in tumour tissue on formalin-fixed paraffin-embedded (FFPE) specimens. Pathway profiling and Gene Set Enrichment Analyses will also be used to generate pathway scores for the 'androgen receptor signaling pathway'; determination of pathway scores for the DNA damage checkpoints and the different DNA repair pathways.
Measured: At baseline and after 12 weeks of neoadjuvant therapy + RP + PLND
Genomic subtyping by exome-sequencing
Genomic subtyping (e.g., ERG, SPINK1, SPOP, FOXA1, PTEN, circulating nucleic acids (CNA) data...) will be performed based on exome-sequencing data. The exome and CNA data will be linked with the transcriptome data on androgen regulation and DNA repair pathways.
Measured: At baseline and after 12 weeks of neoadjuvant therapy + RP + PLND
PSA kinetics
Changes of PSA during time and comparison of PSA values and changes between arms.
Measured: Up to 40 months
Testosterone kinetics
Comparison of total and free serum testosterone and testosterone change between arms
Measured: Up to 40 months
PSA nadir </=0.3ng/ml after neoadjuvant treatment
Differences in proportions of PSA nadir </=0.3ng/ml after neoadjuvant treatment.
PSA nadir after neoadjuvant therapy and before external beam radiotherapy (EBRT) is an important biomarker of hormonal response and an independent prognostic factor of prostate cancer survival.
Measured: After 12 weeks of neoadjuvant therapy before RP + PLND
Peri-operative features
Differences in peri-operative features (operative time, blood loss, grade of surgical difficulty...) will be collected to evaluate the possible effect of treatment on surgical intervention.
Measured: up to (about) 5 hours
Differences in proportions of surgical complications between arms
Clavien-Dindo classification will be implemented to assess differences in surgical complications between the two arms.
Measured: Up to 6 weeks post RP + PLND
Continence
Assessment of continence rates through validated preoperative and postoperative questionnaire (ICIQ)
Measured: Up to 40 months
Quality of life
Assessment of Quality of life through validated preoperative and postoperative questionnaire (EORTC QLQ-C30)
Measured: Up to 40 months
Erection state
Assessment of erection state through validated preoperative and postoperative questionnaire (IEEF5)
Measured: Up to 40 months
Survival
Three years biochemical recurrence free survival
Measured: Up to 36 months
Standardized Uptake Value (SUV) on pelvic [68]Ga PSMA PET/MR per arm
Standardized Uptake Value (SUV) change (delta) per arm comparing SUV values before and after treatment
Measured: At baseline and after 12 weeks of neoadjuvant therapy + RP + PLND
Standardized Uptake Value (SUV) on pelvic [68]Ga PSMA PET/MR between arms
SUV delta between the two arms.
Measured: After 12 weeks of neoadjuvant therapy + RP + PLND
Standardized Uptake Value (SUV) on pelvic [68]Ga PSMA PET/MR and tumour volume
Correlation between SUV values and the tumour volume (TV) in the RP correspondent volume of interest (VOI) at definitive pathology
Measured: After 12 weeks of neoadjuvant therapy + RP + PLND
Standardized Uptake Value (SUV) on prostate [68]Ga PSMA PET/MR and Immunohistochemistry
Correlation between SUV values and PSMA expression at Immunohistochemistry
Measured: After 12 weeks of neoadjuvant therapy + RP + PLND
Magnetic resonance (MR) and tumor volume (TV) per arm
Change of magnetic resonance (MR) tumor volume (TV): Tumor volume (TV) change (delta) per arm comparing TV values before and after treatment
Measured: At baseline and after12 weeks of neoadjuvant therapy + RP + PLND
Magnetic resonance (MR) and tumor volume (TV) between arms
Change of magnetic resonance (MR) tumor volume (TV):TV deltas between the two arms.
Measured: At baseline and after12 weeks of neoadjuvant therapy + RP + PLND
PI-RADS between arms at MR
Proportion of PI-RADS between arms
Measured: After 12 weeks of neoadjuvant therapy + RP + PLND
PI-RADS score and Gleason score
Correlation between PI-RADS score and pathology Gleason score
Measured: After 12 weeks of neoadjuvant therapy + RP + PLND
Down-staging at imaging
Proportion of down-staging
Measured: At baseline and after 12 weeks of neoadjuvant therapy + RP + PLND
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Frequencies of adverse events (AE), severe adverse events (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR)
Measured: From patient inclusion until RP + PLND
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start28 Mar 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Joniau, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080116
- Sponsor's protocol ID
- S58827
- Other IDs
- 2016-002854-19, 2016
- Acronym
- ARNEO
- Status last verified
- Jul 2024
- First submitted
- 14 Feb 2017
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Tosco L, Laenen A, Gevaert T, Salmon I, Decaestecker C, Davicioni E, Buerki C, Claessens F, Swinnen J, Goffin K, Oyen R, Everaerts W, Moris L, De Meerleer G, Haustermans K, Joniau S; P.E.A.R.L. (ProstatE cAncer Research Leuven). Neoadjuvant degarelix with or without apalutamide followed by radical prostatectomy for intermediate and high-risk prostate cancer: ARNEO, a randomized, double blind, placebo-controlled trial. BMC Cancer. 2018 Apr 2;18(1):354. doi: 10.1186/s12885-018-4275-z.
PubMed 29606109
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Degarelix +/- Apalutamide (ARN-509) Followed by Radical Prostatectomy for Intermediate and High-risk Prostate Cancer: a Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03080116
- Acronym / sponsor ID
- ARNEO / S58827
- Keywords
- Randomized, Placebo-controlled, Neoadjuvant, Androgen deprivation, Antiandrogen, Radical Prostatectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Neoadjuvant hormonal therapy using luteinizing hormone releasing hormone (LHRH) agonists and/or anti-androgens has already demonstrated to downstage primary prostate cancer in patients treated by radical prostatectomy without a survival benefit. There is no evidence yet of a survival impact of LHRH antagonist (LHRHa) +/- new-generation anti-androgens in this setting. Thus novel studies are needed to assess this treatment combination.
PURPOSE: To assess the difference in treatment antitumor effect between arms by measuring pathological tumor volume with minimal residual disease (MRD) following radical prostatectomy + pelvic lymph-node dissection (RP + PLND) for intermediate or high-risk prostate cancer patients.
Detailed description
PRIMARY OBJECTIVE: To assess the difference in antitumor effect between the treatment arms by measuring MRD following radical prostatectomy.
SECONDARY OBJECTIVES: To measure differences between study arms in
- Proportions of post neoadjuvant prostate specific antigen (PSA) ≤ 0.3 ng/ml as a predictor of prostate cancer mortality
- T down-staging, complete pathological response, PSA kinetics, Testosterone kinetics, operation time, blood loss, grade of surgical difficulty
- New generation hybrid imaging 68Ga PSMA (Prostate-Specific Membrane Antigen) PET/MR (Positron emission tomography/Magnetic Resonance) derived parameters
- Early biochemical recurrence as prognostic factor of prostate cancer mortality
- Transcriptome and genome
- Tissue microarrays (TMA) protein expression (DNA repair, resistance etc.) by immunohistochemistry
- Perioperative safety and tolerability
- Quality of life, erection recovery, continence through validated preoperative and postoperative questionnaires pre and postop (IEEF5, ICIQ, EORTC QLQ-C30)
OUTLINE: interventional, single center, phase II, randomized, double blind, placebo controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARN-509 + degarelix | Experimental | Drug: ARN-509, Drug: DegarelixTreatment period of 12 weeks before RP + PLND. |
| placebo + degarelix | Active comparator | Drug: Degarelix, Other: PlaceboTreatment period of 12 weeks before RP + PLND. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
- Male aged 18 years or older (within 80 years)
- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
- Diagnosis of intermediate (at least 2 of the following factors: cT2b, biopsy GS 7, PSA 10-20ng/ml) or high-risk prostatic adenocarcinoma (clinical stage≥T2c and/or biopsy GS≥8 and/or PSA>20ng/ml), cN0-cN1, cM0.
Key exclusion criteria (12 listed)
- Previous surgical/endoscopic treatments for prostatic disease
- Herbal and non-herbal products that in the opinion of the investigator may decrease PSA levels
- cM1 disease
- Any contraindication for PET or MR investigations
- History of seizure or condition that may pre-dispose to seizure (e.g., prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARN-509Also: apalutamide240mg/day (4x60mg tablets, Oral administration: OS) | Drug | ARN-509 + degarelix |
| Degarelix1st injection: 120mg Subcutaneous administration (SC) x2, 2nd-3rd SC injection 80mg monthly | Drug | ARN-509 + degarelix, placebo + degarelix |
| Placebo4 tablets, per OS | Other | placebo + degarelix |
Primary outcome
Minimal Residual Disease (MRD)
Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND
Proportions of MRD between arms. MRD: tumor volume ≤ 0.25 cm3
26 secondary outcomes
Difference in proportions of pathological downstage
Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND
Complete pathological response rates
Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND
Difference in proportions of patients with pN1 disease.
Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND
Proteins expression in prostatic tumour TMA's (tissue microarrays)
Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND
Transcriptome analysis by microarray expression platform
Time frame: At baseline and after 12 weeks of neoadjuvant therapy + RP + PLND
Pathway profiling and Gene Set Enrichment Analyses
Time frame: At baseline and after 12 weeks of neoadjuvant therapy + RP + PLND
Genomic subtyping by exome-sequencing
Time frame: At baseline and after 12 weeks of neoadjuvant therapy + RP + PLND
PSA kinetics
Time frame: Up to 40 months
Testosterone kinetics
Time frame: Up to 40 months
PSA nadir </=0.3ng/ml after neoadjuvant treatment
Time frame: After 12 weeks of neoadjuvant therapy before RP + PLND
Peri-operative features
Time frame: up to (about) 5 hours
Differences in proportions of surgical complications between arms
Time frame: Up to 6 weeks post RP + PLND
Continence
Time frame: Up to 40 months
Quality of life
Time frame: Up to 40 months
Erection state
Time frame: Up to 40 months
Survival
Time frame: Up to 36 months
Standardized Uptake Value (SUV) on pelvic [68]Ga PSMA PET/MR per arm
Time frame: At baseline and after 12 weeks of neoadjuvant therapy + RP + PLND
Standardized Uptake Value (SUV) on pelvic [68]Ga PSMA PET/MR between arms
Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND
Standardized Uptake Value (SUV) on pelvic [68]Ga PSMA PET/MR and tumour volume
Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND
Standardized Uptake Value (SUV) on prostate [68]Ga PSMA PET/MR and Immunohistochemistry
Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND
Magnetic resonance (MR) and tumor volume (TV) per arm
Time frame: At baseline and after12 weeks of neoadjuvant therapy + RP + PLND
Magnetic resonance (MR) and tumor volume (TV) between arms
Time frame: At baseline and after12 weeks of neoadjuvant therapy + RP + PLND
PI-RADS between arms at MR
Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND
PI-RADS score and Gleason score
Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND
Down-staging at imaging
Time frame: At baseline and after 12 weeks of neoadjuvant therapy + RP + PLND
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From patient inclusion until RP + PLND
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 29606109Tosco L, Laenen A, Gevaert T, Salmon I, Decaestecker C, Davicioni E, Buerki C, Claessens F, Swinnen J, Goffin K, Oyen R, Everaerts W, Moris L, De Meerleer G, Haustermans K, Joniau S; P.E.A.R.L. (ProstatE cAncer Research Leuven). Neoadjuvant degarelix with or without apalutamide followed by radical prostatectomy for intermediate and high-risk prostate cancer: ARNEO, a randomized, double blind, placebo-controlled trial. BMC Cancer. 2018 Apr 2;18(1):354. doi: 10.1186/s12885-018-4275-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Joniau principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARN-509 and Degarelix in people with Prostate Cancer and Neoadjuvant Therapy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Residual Disease (MRD) (time frame: After 12 weeks of neoadjuvant therapy + RP + PLND). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03080116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.