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Single Blind Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer

- Primary study objective: To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.- Secondary study objectives: Establish and compare…

Personalizing enzalutamide (Xtandi®) therapy by understanding the relation between the decrease in the expression profile of a panel of preselected microRNAs, tumor related mRNAs and treatment response in patients with mCRPC (ILUMINATE)

Primary Objectives:To explore whether the decrease in a panel of early easily assessable biomarkers (PSA-mRNA, PCA3-mRNA and TMPRSS2:ERG gene fusion-mRNA, (currently under development) ARv7 mRNA, ARwt mRNA, miR-21, miR-141, miR-200a, miRrumc95,…

Ligasure versus conventional surgery for inguinofemoral lymphadenectomy in vulvar cancer patients; MAMBO-IC

Our primary objective is to assess the differences in the incidence of short term complications (wound infection, wound breakdown and lymphocele) after IFL using LigaSure versus the conventional method. Furthermore, we will assess the differences in…

Individual risk assessment for prostate cancer: an impact analysis.

The proposed project aims at implementing the available scientific knowledge for recommending biopsies or active treatment, respectively, at the individual level in Dutch urological practice. To this end we have developed an internet based decision…

Randomised Controlled Study on the Effects of Imiquimod, a TLR 7 Activating Agent, on the HPV16-Specific Immune Response Following HPV16 E6/E7 Synthetic Long Peptides Vaccination in Women with HPV16 Positive High Grade Vulvar/Vaginal Intraepithelial Neoplasia.

Primary objective:To compare the immunological response to vaccination with HPV16 E6 and E7 synthetic long peptides with concomitant application of imiquimod at the vaccination site with vaccination without the concomitant application of imiquimod.…

A PHASE I, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ESCALATING DOSES OF DMOT4039A IN PATIENTS WITH UNRESECTABLE PANCREATIC OR PLATINUM-RESISTANT OVARIAN CANCER

The primary objectives of this study are the following:• To evaluate the safety and tolerability of DMOT4039A when administered every 3 weeks or weekly to patients with unresectable pancreatic or platinum-resistant ovarian cancer• To determine the…

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.

The effects of neoadjuvant hormonal therapy on the course of PSA and testosterone in patients with low and intermediate risk prostate carcinoma (NEO-ONE)

To assess the effects of 3-month NHT on the 3-year course of PSA and testosterone in patients treated with BT for low-intermediate risk clinically localized prostate carcinoma. In addition, we would like to assess the effects of 3-month NHT on…

An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients with Prostate Cancer Requiring Androgen Deprivation Therapy

Primary Objective - To evaluate the time to PSA >4 ng/mL during the first cycle of IAD after the end of an induction period with degarelix (7 monthly treatments) in prostate cancer patientsSecondary Objectives - To evaluate the time to PSA .4…

Therapeutic Drug Monitoring to Individualize the Dosing of pazopanib: a Randomized Pharmacokinetic Feasibility Study

Primary objectiveTo evaluate the effect of PK-guided individualized dosing of pazopanib on the interindividual variability in drug exposure.Secondary objective- To determine the correlation between pazopanib trough and exposure levels - To determine…

Safety, efficacy and immunogenicity of HPV 16 E7 DNA vaccination in HPV related squamous cell cancer.

To study the toxicity, efficacy and immunogenicity of naked DNA vaccines encoding the shuffled HPV 16 E7 gene products (TTFC-E7SH) in advanced-stage patients with squamous cell carcinoma of the anogenital or the head and reck region.

Prospective multi-centre study of low-dose Iodine125 (I-125) prostate brachytherapy performed after transurethral resection. PROBATE study

To test in a prospective study the feasibility and outcome of low dose rate I-125 seed brachytherapy to treat early low risk prostate cancer in patients who have had previous TURP using specific recommendations on target and organs at risk dose…

Clinical and immunological effects of imiquimod and HPV-vaccination compared to imiquimod alone in female patients with Usual type VIN: proof of principle.

Primary objectives: (1) Evaluation of the efficacy of vaccination against HPV 16, 18, 6 and 11 followed by local applications of imiquimod 5% cream compared to treatment with imiquimod alone for usual type VIN, (2) evaluation of the systemic and…

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Men with Hormone-Refractory Prostate Cancer.

To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal-related event (SRE) in men with hormone-refractory prostate cancer and bone metastases.

SEMINAL VESICLE MOTION RELATIVE TO THE PROSTATE

To quantify the motion of the seminal vesicles.

A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients

To Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients compared to placebo.

A Randomized, Double-blind, Multicenter, Phase 2 Study of a Human Monoclonal Antibody to Human aV Integrins (CNTO 95) in Combination With Docetaxel and Prednisone for the First-Line Treatment of Subjects With Metastatic Hormone Refractory prostate Cancer

Evaluate the efficacy and safety of treatment with CNTO 95 in combination with docetaxel and prednisone compared with docetaxel and prednisone without CNTO 95 in subjects with metastatic HRPC.

Phase II multi-centric, randomised, open-label, parallel-group study to assess the non-inferiority of Pamorelin® 11,25 mg SC injected versus Pamorelin® 11,25 mg IM injected in patients suffering from advanced prostate cancer

Primary Study ObjectiveTo assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via registered intramuscular (IM) injection…

A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer

Primary Efficacy Objectives:To ascertain whether the overall survival of subjects randomized to Arm V+G (PROSTVAC-V/F plus GM-CSF) or to Arm V (PROSTVAC-V/F) is superior to that from subjects randomized to Arm P (placebo control).Secondary Efficacy…

Prostate cancer and diet - a randomized controlled trial on the effect of a dietary intervention on the quality of life of men and serum nutrient levels in their blood.

Primary objective: to improve participants* quality of life, as measured by the SF-12 general health domain, by actively engaging in a prostate cancer diet. Secondary objectives: - To improve participants* feeling of being in control of their…