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Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis

To provide access to Radium-223 dichloride to patients diagnosed with CRPC/HRPC with bonemetastasis.

Phase III randomised clinical trial for stage III ovarian carcinoma randomising between secondary debulking surgery with or without hyperthermic intraperitoneal chemotherapy (OVHIPEC-I)

Objective: The primary objectives of this study are comparing the duration of recurrence free survival following completion of treatment between the 2 study arms. Secondary objectives of this study involves toxicity and morbidity, quality of life,…

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients with Metastatic Castration-Resistant Prostate Cancer

Primary Objective:To compare the clinical benefit of abiraterone acetate plus prednisone versus placebo plus prednisone in patients with chemotherapy-naïve castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic.…

A Multi-National, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX??) and Carboplatin vs. Paclitaxel and Carboplatin in Patients with Epithelial Ovarian Cancer in Late Relapse (>6 months)

The main purpose of this research study is to find out if treatment of late relapse with liposomal doxorubicin (Caelyx) combined with carboplatin will control the tumor growth at least as well as standard treatment of paclitaxel and carboplatin.…

Phase III, open-label, multi-center study to assess the pharmacodynamic (PD), pharmacokinetic (PK) and safety of Zoreline 10.8 mg goserelin subcutaneous implant (Novalon) in male patients with prostate cancer

To assess the PD, PK and safety of the Zoreline 10.8 mg goserelin subcutaneous (SC) implant.

A PHASE III RANDOMIZED TRIAL OF GEMCITABINE PLUS DOCETAXEL FOLLOWED BY DOXORUBICIN V. OBSERVATION FOR UTERUS-LIMITED, HIGH GRADE UTERINE LEIOMYOSARCOMA

To improve overall survival of patients with a early-stage high grade uterine leiomyosarcoma.

Optimisation of [68Ga] PSMA-11 PET/CT Imaging Protocol for localizing primary prostate cancer prior to radical prostatectomy

The primary objective is to determine the optimal pharmacokinetic model of 68Ga-PSMA PET/CT, so 68Ga-PSMA PET/CT results can be quantified in prostate cancer.The secondary objectives are to determine whether the optimal kinetic model of 68Ga-PSMA…

A European randomised Phase 3 study to assess the efficacy and safety of TOOKAD® Soluble for localised prostate cancer compared to Active Surveillance

Primary Objective:To assess the impact of TOOKAD® Soluble VTP on the rate of absence of definite cancer using patients onactive surveillance as a comparison (co-primary objective A).To determine the difference in risk of treatment failure associated…

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…

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/…

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 III study of [18F]PSMA-1007 positron emission tomography for the detection of prostate cancer lesions in patients with biochemical recurrence after previous definitive treatment for localized prostate cancer

There are two co-primary study objectives:• Region-level positive predictive value (PPV) defined as the percentage of all PET-positive regions containing at least one true positive lesion (exactly localized correspondence between [18F]PSMA-1007 PET…

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 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-…

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…

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

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…

Randomized multicenter, phase III trial evaluating the safety of 2 schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (* 65 years) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen (CABASTY).

To evaluate the incidence of grade * 3 neutropenia (measured at Day 7 and Day 14) and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in…

Repeated Rhenium-188-HEDP versus Radium-223-chloride in patients with metastatic castration-resistant prostate cancer: the RARE study.

The objective of this trial is to compare standard treatment with radium-223-chloride (proven surivval benefit) with treatment with rhenium-188-HEDP, which is nowadays only used for pain palliation. This trial includes patients with metastatic…