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The use of indocyanine green for accurate sentinel node detection and removal in a group of high-risk nodal metastasis prostate cancer patients
To optimize and improve the sentinel node procedure in men with prostate cancer

The overall goal of this study is to further validate and improve the sentinel node procedure for prostate cancer using ICG-99mTc-nanocolloid. The first objective aims at further validation of the sentinel node procedure for prostate cancer via…

Prostate volume measurement by the general practitioner

In this research project it is investigated if abdominal ultrasound measurement of prostate volume performed by the GP is equivalent to the prostate volume measured by the transrectal ultrasound (TRUS) performed by the urologist. Also the effect on…

A prospective Multicenter Randomized Study Comparing Photoselective Vaporization of the Prostate with the GreenLight XPS Laser System and Transurethral resection of the Prostate for Treatment of benign Prostatis Hyperplasia

The study will compare procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP). The study requires use of the CE marked GreenLight XPS* Laser System (GreenLight…

A pilot study to compare HistoScanning guided prostate biopsy with systematic biopsy in the detection of prostate cancer.

The primary objective of this study is to compare HistoScanningTM guided prostate biopsy with systematic biopsy in the detection of prostate cancer in men candidate for a first or second biopsy procedure.

A randomized phase II trial of docetaxel plus carboplatin versus docetaxel in hormone refractory prostate cancer patients who have progressed after response to prior docetaxel chemotherapy: RECARDO STUDY

Primary objectives:* Progression-free survival (PFS) defined as either of the following occurrences, whichever comes first:o PSA progression o Progressive disease according to RECIST when measurable diseaseSecondary objectives:* Toxicity profile.*…

A Randomized, Open Label, Phase III, Multicenter, 2-Arm Study of Androgen deprivation +/- Taxoterere* (Docetaxel) for Non metastatic Prostate Cancer Patients with a Rising PSA.

To evaluate and compare progression free survival (PSA) between the two treatment arms.

A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination with Custirsen (OGX-011) in Men with Metastatic Castrate Resistant Prostate Cancer

To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm.

A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs. Prednisone in Metastatic Castration-resistant Prostate Cancer Patients who have Received Prior Docetaxel and Prior Abiraterone or MDV3100

The objective of this study is to evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease…

A Phase II Study of PHA-739358 in Patients with Metastatic Hormone Refractory Prostate Cancer.

1) To assess the antitumor activity of PHA-739358 administered as IV infusion according to two different dose schedules in metastatic HRPC patients progressing on standard docetaxel-based chemotherapy.2) To have a precise idea of the antitumor…

VISION: An international, prospective, open label, multicenter, randomized Phase 3 study of 177LU-PSMA-617 in the treatment of patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC)

The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/…

Prostate cancer Research International: Active Surveillance (PRIAS) MRI study

To study the value of mpMRI with subsequent targeted biopsies after inclusion to more accurately grade prostate cancers of men on active surveillance. Furthermore, the value of mpMRI in reducing the number and amount of biopsies will be studied.

Effectiveness of focal therapy in men with prostate cancer (ENFORCE)

We hypothesize that a significant proportion of the patients will benefit more from focal therapy as compared to usual care in terms of morbidity and quality of life, without compromising oncological effectiveness. Primary objective: To study the…

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

This study has been transitioned to CTIS with ID 2023-506365-64-00 check the CTIS register for the current data. The purpose of this study is to investigate if niraparib added to a standard treatment (consisting of abiraterone acetate plus…

Tracer-Based Imaged Guided Surgery for Recurrent Prostate Cancer: A Prospective Randomized Controlled Trial - TRACE II

Evaluate the clinical progression free survival after randomization to either 6 months of androgen deprivation therapy (ADT) or 6 months of ADT plus a 99mTechnetium (99mTc)-based PSMA-radioguided salvage surgery.

PROCADE: A Multinational Phase 3, Randomized, Double-Blind, Non-Inferiority, Efficacy and Safety Study of Oral HC-1119 versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Primary Objective:• To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) until 24 weeks.Key Secondary Objective:• To…

Determining the clinical relevance of the interaction between enzalutamide and the opioid morphine and the DOAC edoxaban to improve rational pharmacological care of patients with prostate cancer

This study has been transitioned to CTIS with ID 2024-517646-34-00 check the CTIS register for the current data. The objective of this study is to evaluate the effect of enzalutamide on morphine and edoxaban pharmacokinetics. This information is…

A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration resistant Prostate Cancer (mCRPC) Who are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment with One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)

1) To compare pembrolizumab plus olaparib to abiraterone acetate or enzalutamide with respect to overall survival (OS)2) To compare pembrolizumab plus olaparib to abiraterone acetate or enzalutamide with respect to radiographic progression-free…

Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy (PREDICT-Study)

To compare the oncologic outcomes of PCa patients with an estimated risk of lymph node invasion of 5-20% according to the Briganti nomogram without metastases on PSMA PET/CT undergoing a radical prostatectomy (RP) with or without an ePLND.

Two-fraction Ultra-hypofractionated Radiotherapy with Focal Boost for low- and intermediate risk, localized prostate cancer (TURBO):phase II, randomized controlled clinical trial

To assess non-inferiority of treating patients with localized, intermediate risk prostate cancer in two fractions of 12 Gray (Gy) with a boost to the gross tumor volume of 13.5 Gy per fraction in 8 days, as compared to standard care (36.25 Gy in…

Multi-institutional Evaluation of the Cost-effectiveness of PSMA-PET/CT
for the Detection of Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer
Patients

This study has been transitioned to CTIS with ID 2024-518171-59-00 check the CTIS register for the current data. To determine if the use of Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET/CT) as a selection tool…