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Pilot study: Toxicity of oestradiol for adjuvant endocrine therapy in locally confined prostate cancer

To analyse the safety of oestradiol in the setting of endocrine treatment for locally extended prostate cancer adjuvant to radiotherapy.

HERO: A Multinational Phase 3 Randomized, Open-label,
Parallel Group Study to Evaluate the Safety and Efficacy of
Relugolix in Men with Advanced Prostate Cancer

Primary:• To evaluate the ability of relugolix to achieve and maintain serum testosterone suppression to castrate levels (<= 50 ng/dL [1.7 nmol/L]) in men with androgen-sensitive advanced prostate cancer.Secondary:• To evaluate the time…

Transperineal Laser Ablation for Focal Prostate Cancer: Safety and Ablative Efficacy evaluation using post-radical Prostatectomy Histological Analysis

The primary objective of this study is to determine histological ablative efficacy by absence of vital (tumour) cells in the treated prostate zone with (multi)fibre setup in men with PCa scheduled for radical prostatectomy. The secondary objectives…

Feasibility of MRI-guided focal salvage high-dose-rate brachytherapy for locally recurrent prostate cancer

To assess toxicity of MRI guided focal salvage high-dose-rate brachytherapy as monotherapy in patients with locally recurrent prostate cancer. As secondary objectives, technical feasibility, quality of life and biochemical free survival (Phoenix…

A Multi-Center Randomized Single-Blind Two Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Prostate Cancer

Primary: - To evaluate differences in side effect profile of patients treated with focal or extended ablation performed with image-guided IRE for the ablation of prostate carcinoma. - To evaluate differences in quality of life of patients treated…

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/…

Phase 2 INSPIRE trial: Ipilimumab with Nivolumab in molecular-Selected patients with castration-resistant PRostate cancer

This study has been transitioned to CTIS with ID 2024-513186-39-00 check the CTIS register for the current data. Primary objective:To evaluate the efficacy of nivolumab in combination with ipilimumab in molecular pre-selected patients with…

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…

PERICLES (PEnile cancer Radio- and Immunotherapy CLinical Exploration Study) - a Phase 2 study of atezolizumab with or without radiotherapy in penile cancer

The primary objective is efficacy of atezolizumab in advanced penile cancer patients measured by progression-free survival.

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…

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic
Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

This study has been transitioned to CTIS with ID 2023-506987-15-00 check the CTIS register for the current data. 1) Objective: To evaluate the safety and tolerability of the pembrolizumab combination therapy.2) Objective: To estimate PSA response…

Tolerability of concurrent EBRT + Lu-PSMA for node-positive prostate cancer (PROQURE-1)

This study has been transitioned to CTIS with ID 2024-514168-15-00 check the CTIS register for the current data. Primary: To determine the maximum tolerated dose (MTD) of 1 or 2 cycli Lu-PSMA when given concurrent with EBRT+ADT. Secondary: To…

An open-label, randomized study to assess the relative bioavailability (BA) and bioequivalence (BE) of fixed-dose combination (FDC) formulations of niraparib plus abiraterone acetate (AA) compared to niraparib and AA co-administered as single agents in men with prostate cancer

This study has been transitioned to CTIS with ID 2023-508150-26-00 check the CTIS register for the current data. Primary Objectives:- To determine the BE of a RS FDC tablet formulation of niraparib and Abiraterone Acetate with respect to niraparib…

Phase I dose escalation study to evaluate tolerability and safety of 225Ac-PSMA in patients with metastatic prostate cancer

This study has been transitioned to CTIS with ID 2024-513729-22-01 check the CTIS register for the current data. 1.1 Primary study objectives To investigate the safety, tolerability and biochemical effects of 225Ac-PSMA injected in patients with…

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…

Towards optimal treatment for high risk prostate cancer; stereotactic pelvic radiotherapy with focal boost to the primary tumor

Determine the safety (oncological outcome and toxicity) of an comprehensive treatment combining recent advances in the treatment of high risk prostate cancer.

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-…