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PSMA-PET guided hypofractionated salvage prostate bed radiotherapy of biochemical failure after radical prostatectomy for prostate cancer

The main goal of this project is to investigate whether the oncologic outcome in patients with post-prostatectomy recurrent PCa can be improved, by increasing the biological effective radiation dose using a hypofractionated schedule of 20 x 3 = 60…

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/…

Evaluation of Prostate-Specific Antigen Glycomics Assay for the Early Detection of Prostate Cancer

The current research is focused on finding a method that is able to better stratify the patients. A possible method could be to study PSA in more detail, specifically the modifications which are present on the protein. One of these modifications is…

Effect of a reduced dose on cognitive side effects of enzalutamide in frail (m)CRPC patients

Primary objectives- To determine the decrease in the CNS side effect fatigue* in frail (m)CRPC patients treated with a reduced dose of enzalutamide (120mg OD) compared to the standard dose of enzalutamide (160mg OD) after 6 weeks of…

Impact of peri-operative tEstosterone levels oN Functional and oncological Outcomes following RadiCal prostatEctomy (ENFORCE)

This study has been transitioned to CTIS with ID 2024-511340-29-00 check the CTIS register for the current data. Primary Objective: Evaluate if testosterone replacement therapy (TRT) in (a)symptomatic testosterone deficient men with prostate cancer…

A RANDOMIZED PHASE III TRIAL COMPARING CONVENTIONAL-DOSE CHEMOTHERAPY USING PACLITAXEL, IFOSFAMIDE, AND CISPLATIN (TIP) WITH HIGH-DOSE CHEMOTHERAPY USING MOBILIZING PACLITAXEL PLUS IFOSFAMIDE FOLLOWED BY HIGH-DOSE CARBOPLATIN AND ETOPOSIDE (TI-CE) AS FIRST SALVAGE TREATMENT IN RELAPSED OR REFRACTORY GERM CELL TUMORS

This study has been transitioned to CTIS with ID 2024-513509-30-00 check the CTIS register for the current data. To compare the overall survival of patients with relapsed or refractory GCT treated with conventional-dose chemotherapy using the TIP…

Resistance exercise training and protein supplementation to prevent side effects of androgen deprivation therapy (ADT) in men with prostate cancer

To investigate if a combined intervention of resistance training and protein supplementation is more effective to prevent or decrease the adverse effects of ADT on body weight and body composition in men with PC compared to training alone or usual…

Standard moderately hypofractionated radiotherapy vs. ultra-hypofractionated focal lesion ablative microboost in prostate cancer, Hypo-FLAME 3.0

To demonstrate superiority of whole gland SBRT with a simultaneous integrated focal boost 35/50 Gy in 5 fractions (Hypo-FLAME) regarding 5-year bDFS compared to the current standard moderately hypofractionated schedule of 62 Gy in 20 fractions of 3.…

Phase II randomised controlled trial of patient-specific adaptive versus continuous Abiraterone or eNZalutamide in metastatic castration-resistant prostate cancer: the ANZadapt study

The primary objective is to investigate whether the patient-specific adaptive treatment with AA/ENZ leads to a superior time to time to treatment failure (TTTF) while on treatment compared to continuous treatment with AA/ENZ. Secondary/tertiary…

Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

This study has been transitioned to CTIS with ID 2024-513867-19-00 check the CTIS register for the current data. Primary objective:Compare overall survival for subjects treated with docetaxel versus subjects treated with docetaxel plus raduim-…

A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve subjects with bone predominant metastatic castration-resistant prostate cancer (CRPC)

to provide access to Radium-223 dichloride together with abiraterone and prednisone to patients diagnosed with CRPC with bonemetasasis.

A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus
Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men
With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive
Therapy.

This study has been transitioned to CTIS with ID 2024-513521-23-00 check the CTIS register for the current data. All efficacy and safety objectives will compare enzalutamide plus leuprolide and enzalutamide monotherapyversus placebo plus leuprolide.

Randomized trial for the evaluation of erectile dysfunction after whole or partial gland
prostate brachytherapy: POWER (Partial or Whole gland for Erections)

The main objective is to assess if partial prostate brachytherapy will lead to less erectile dysfunction than whole gland prostate brachytherapy.Secondary objectives are:- To assess differences in urinary and rectal late effects between whole gland…

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…

IVD1: Clinical Performance Study Plan For The Use of Myriad MyChoice® For Patient Enrolment Into the AZD5305 (Saruparib) vs Placebo in Participants with Metastatic Castration-Sensitive Prostate Cancer Receiving Physician*s Choice New Hormonal Agents;IVD2: Clinical Performance Study Plan for F1LCDx Used in Clinical Trial EvoPAR-Prostate01 ;Main: A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination with Physician*s Choice New Hormonal Agents in Patien

IVD1: The primary objective of this clinical performance study is to evaluate the effectiveness of the MyChoice® test in identifying HRRm or non-HRRm mCSPC patients as part of the enrolment criteria for EvoPAR-prostate01. This clinical performance…

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…

A randomized phase II trial of docetaxel or cabazitaxel with or without darolutamide in men with metastatic castration-resistant prostate cancer.

This study has been transitioned to CTIS with ID 2024-516939-28-00 check the CTIS register for the current data. To compare progression free survival (PFS) between treatment with docetaxel or cabazitaxel and darolutamide versus treatment with…

A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate Cancer Who Have Received Prior Chemotherapy Containing Docetaxel

Primary:To compare the efficacy of olaparib when given in addition to abiraterone, with placebo givenin addition to abiraterone, by assessment of radiologic progression-free survival (rPFS) usingResponse Evaluation Criteria in Solid Tumours version…

ARCHES:A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Primary Objective- To determine the benefit of enzalutamide plus ADT as compared to placebo plus ADT as assessed by radiographic progression-free survival (rPFS) based on central reviewMain Secondary Objectives- To determine the benefit of…