Treatment period of 12 weeks before RP + PLND.

Prostate Cancer

Neoadjuvant Therapy

Androgen Antagonists

Prostatectomy

240mg/day (4x60mg tablets, Oral administration: OS)

ARN-509

1st injection: 120mg Subcutaneous administration (SC) x2, 2nd-3rd SC injection 80mg monthly

Degarelix

Placebo

University Hospitals Leuven

Neoadjuvant Degarelix With or Without Apalutamide (ARN-509) Followed by Radical Prostatectomy

Neoadjuvant Degarelix +/- Apalutamide (ARN-509) Followed by Radical Prostatectomy for Intermediate and High-risk Prostate Cancer: a Randomized, Placebo-controlled Trial

Proportions of MRD between arms. MRD: tumor volume ≤ 0.25 cm3

Any decrease in T stage from clinical to pathological stage

Difference in proportions of complete pathological response (no evidence of tumour in the postoperative specimen) between arms.

Difference in proportions of lymph node invasion between arms

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.

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.

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.

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.

Changes of PSA during time and comparison of PSA values and changes between arms.

Comparison of total and free serum testosterone and testosterone change between arms

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.

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.

Clavien-Dindo classification will be implemented to assess differences in surgical complications between the two arms.

Assessment of continence rates through validated preoperative and postoperative questionnaire (ICIQ)

Assessment of Quality of life through validated preoperative and postoperative questionnaire (EORTC QLQ-C30)

Assessment of erection state through validated preoperative and postoperative questionnaire (IEEF5)

Three years biochemical recurrence free survival

Standardized Uptake Value (SUV) change (delta) per arm comparing SUV values before and after treatment

Correlation between SUV values and the tumour volume (TV) in the RP correspondent volume of interest (VOI) at definitive pathology

Correlation between SUV values and PSMA expression at Immunohistochemistry

Change of magnetic resonance (MR) tumor volume (TV): Tumor volume (TV) change (delta) per arm comparing TV values before and after treatment

Change of magnetic resonance (MR) tumor volume (TV):TV deltas between the two arms.

Correlation between PI-RADS score and pathology Gleason score

Frequencies of adverse events (AE), severe adverse events (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR)

Universitaire Ziekenhuizen Leuven

Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.

Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.
darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.

Presurgical Molecular Assessment

Age, Customized

Sex: Female, Male

Race/Ethnicity, Customized

Region of Enrollment

Menopausal Status

Breast Cancer Sub-Type

The ECOG Scale of Performance Status is a measurement used to describe a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.).
Patients with ECOG 0 are in better general condition than patients with ECOG 1:
0 = Fully active, able to carry on all pre-disease performance without restriction.
1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Androgen Receptor (AR) was assessed on the collected samples.

Identifying Molecular Alterations in Breast Cancer Tissue Tumor Samples Following Short-Term Preoperative Exposure to Darolutamide in Female Patients Wit Early Breast Cancer.

The assessment of safety will be performed for all subjects who have taken at least one tablet of darolutamide (defined as the "safety population")

Number of Participants With Treatment-related Adverse Events (TEAE) as Assessed by CTCAE v4.03

Overall Study

Director, Project Management

Breast Cancer Female

Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.

darolutamide

UCLA

Valley Breast Care and Women's Health Center

Torrance Memorial Physician Network, Cancer Care Associates

Central Coast Medical Oncology

UF Health Cancer Center - Orlando Health

Cross Cancer Institute

Centre Hospitalier de l'Université de Montréal (CHUM)

Jewish General Hospital

McGill University Hospital

(CIUSSS) de l'Est-de-l'Île-de-Montréal - l'Hôpital Maisonneuve-Rosemont

Centre Hospitalier Affilie Universitaire De Quebec - Hospital Du Saint-Sacrement

Universitatsklinikum Erlangen

Interdisziplinares Onkologisches Zentrum

Department of Women's Health

A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide

A Presurgical Tissue-Acquisition Study to Evaluate Molecular Alterations in Human Breast Cancer Tissue Following Short-Term Exposure to the Androgen Receptor Antagonist Darolutamide (ODM-201)

Translational Research in Oncology

Bayer

PCOS

Furocyst

Effect of fenugreek seeds and leaves on blood glucose and serum insulin responses in human subjects

Dept of Obs & Gynae, King George's Medical University, Lucknow, UP, India

Furocyst - Poly Cystic Ovary Syndrome Study

To Study the Efficacy and Safety of Furocyst in Poly Cystic Ovary Syndrome Patients (PCOS)

Chemical Resources

Every patient will be given diet and exercise counseling in both arms. Intervention arm will receive metformin

Polycystic Ovary Syndrome

Metformin

Hospital Privado de Córdoba

Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome

Clinical Metabolic and Endocrine Parameters in Response to Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome: A Phase 4 Randomized, Double- Blind and Placebo Control Trial

antiandrogens/hemorrhage

Neoadjuvant Degarelix With or Without Apalutamide (ARN-509) Followed by Radical Prostatectomy

A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide

Furocyst - Poly Cystic Ovary Syndrome Study

Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome

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