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A Master Protocol Evaluating the Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC);- Subprotocol A: A Phase 1b Study Evaluating the Safety and Efficacy of AMG 160 in Combination With Enzalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Subprotocol B: A Phase 1b Study Evaluating the Safety and Efficacy of AMG 160 in Combination With Abiraterone in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Primary objective: To evaluate the safety, tolerability, and maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of investigational therapies in subjects with metastatic castration-resistant prostate cancer (mCRPC).Secondary objective:*…

CLINICAL PROTOCOL for the INVESTIGATION Of the ProSpace* Balloon Spacer Pivotal Study BP-007

to demonstrate that the ProSpace, when properly inserted between the prostate and the rectum is safe and effective in reducing the volume of the rectum receiving greater or equal to 70 Gy (VRectum70) by means of IMRT in prostate cancer patients…

A FEASIBILITY STUDY OF 177LU-PSMA RADIOLIGAND THERAPY ALTERNATED WITH RADIUM-223 IN PATIENTS WITH BONE-METASTATIC, OLIGO-METASTATIC HORMONE-SENSITIVE PROSTATE CANCER AFTER CURATIVE THERAPY. THE DUET STUDY

This study has been transitioned to CTIS with ID 2024-518985-29-02 check the CTIS register for the current data. To prospectively investigate if a treatment strategy in which two types of cytotoxic RLT, i.e., an alpha-emitter and a beta-emitter, are…

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 randomized, open label, Phase IIB trial of Optimal Sequencing of Treatment Options for Poor Risk Metastasized Castration Resistant Prostate Cancer Previously Treated with Docetaxel (OSTRICh trial)

Primary: * To assess Clinical Benefit Rate (CBR) in patients with mCRPC and poor prognostic factors treated with cabazitaxel or novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy.Secondary: * To formally compare CBR in both…

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.

Transperineal Laser Ablation for treatment of LUTS due to benign prostatic obstruction

The primary objective of this study is to prove feasibility and safety of TPLA for LUTS due to BPO in healthy men. The secondary objectives are to determine functional voiding, erectile outcomes and changes on imaging.

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 Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer

The purpose of this study is to understand if a new treatment for prostate cancer (niraparib) added to a standard treatment (abiraterone acetate plus prednisone) will work better than the standard treatment alone.Cohort 3: the purpose is to evaluate…

RObotic mri-guided high dose rate Brachytherapy Needle implantation in the proState - a proof of concept study

To investigate the technical feasibility of inserting a brachytherapy needle into the prostate to a defined tumour target point using a robotic device.

Clinical validation of transrectal multiparametric ultrasound imaging strategy (PCaVision) for the detection of clinically significant prostate cancer: a European head-to-head comparison with the MRI-based strategy in primary diagnosis and in an active surveillance population

The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (defined as GG>=2) in targeted biopsies based on PGaVision imaging (PCaVision pathway) in comparison with the detection…

Addition of a Focal boost In external beam Radiotherapy for locally advanced prostate cancer by online adaptive MR-guided radiotherapy (AFFIRM trial)

In the present study the clinical feasibility and safety of MR-guided focal boost radiotherapy for patients with locally advanced prostate cancer will be evaluated.

Magnetic resonance imaging-guided focal laser ablation of prostate cancer

Primary objectiveThe primary objective for this phase IIa study is to investigate the feasibility, usability and safety of CLS MR-guided FLA in the treatment of prostate cancer.Secondary objectiveTo assess tumor response and functional outcomes

An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer-sponsored studies

This study has been transitioned to CTIS with ID 2022-502084-38-00 check the CTIS register for the current data. Primary- Continuation of treatment- SafetySecondairy- Documentation of tolerability

Clinical validation of transrectal multiparametric ultrasound imaging strategy (PCaVision) for the detection of clinically significant prostate cancer: a head-to-head comparison with the MRI-based strategy

• The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (defined as GG >= 2) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the…

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Delta-like Protein 3 Half-life Extended Bispecific T-cell Engager AMG 757 in Subjects with De Novo or Treatment Emergent Neuroendocrine Prostate Cancer

This study has been transitioned to CTIS with ID 2024-513316-10-00 check the CTIS register for the current data. Primary:• To Evaluate the safety and tolerability of tarlatamab • Determine the maximum tolerated dose (MTD) or recommended phase 2 dose…

177Lu-PSMA RADIOLIGAND THERAPY IN PATIENTS WITH LYMPH NODE METASTATIC HORMONE-SENSITIVE PROSTATE CANCER UNDERGOING ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY AND EXTENDED PELVIC LYMPH NODE DISSECTION

To investigate if surgery is feasible and safe in patients with newly diagnosed lymph node metastatic HSPCa who have received two cycles of (neo-adjuvant) systemic 177Lutetium (Lu)-labeled prostate-specific membrane antigen (PSMA) radioligand…

An open-label, multicentre, single arm study to assess the efficacy and safety of triptorelin 6-month formulation administered subcutaneously in participants with locally advanced and/or metastatic prostate cancer previously treated and castrated with a GnRH analogue

To evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered subcutaneously in maintaining serum testosterone castrate levels in participants with advanced prostate cancer previously treated and castrated with a GnRH…