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Prostatic Neoplasms clinical trials

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NCT ID: NCT01731912 Completed - Clinical trials for Prostate Adenocarcinoma

Degarelix Acetate Before and During Radiation Therapy in Treating Patients With Prostate Cancer

Start date: May 2013
Phase: N/A
Study type: Interventional

This pilot clinical trial studies how well degarelix acetate before and during radiation therapy works in treating patients with prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as degarelix acetate, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving degarelix acetate together with radiation therapy may work better in treating prostate cancer.

NCT ID: NCT01729676 Completed - Prostate Cancer Clinical Trials

Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation

FACT
Start date: May 2013
Phase: N/A
Study type: Observational

French epidemiological data have shown a heterogeneous distribution of the risk of mortality from prostate cancer according to region. The main objective is to describe the distribution of prostate cancer stages when first line hormonal therapy is introduced (overall and by region).

NCT ID: NCT01729442 Completed - Prostate Cancer Clinical Trials

Assessment of HIFU-induced Prostate Necrosis With Shear-wave Ultrasound Elastography

IDITOP-1
Start date: October 2012
Phase: N/A
Study type: Interventional

Transrectal High-intensity Focused Ultrasound (HIFU) is a minimally-invasive therapy for prostate cancer that is currently assessed in two indications: as a first-line treatment (either total or focal) for patients who are not eligible for surgery and as a salvage treatment of local recurrences after radiotherapy. It has recently been shown that Contrast-Enhanced Ultrasound (CEUS) can accurately assess the position and volume of tissue destruction at the end of prostate HIFU ablation. This can provide live feedback regarding the amount of residual non ablated tissue after HIFU treatment, which could allow immediate re-treatment in case of unsatisfactory result. CEUS requires the injection of micro-bubbles of sulphur hexafluoride (Sonovue, Bracco, Milan, Italy) which can, at least in theory, interfere with HIFU treatment. Therefore, it is necessary to wait 20 to 30 minutes before re-treating the patient. Shear-wave ultrasound elastography (SWUE, Supersonic Imagine, Aix-en-Provence, France) can quantify tissue stiffness. Moreover, post-HIFU necrosis is known to be stiffer than undestroyed prostate tissue. Therefore, SWUE could be an alternative to CEUS, and the purpose of this study is to evaluate the accuracy of SWUE in depicting the position and volume of therapeutic necrosis after prostate cancer High-Intensity Focused Ultrasound (HIFU) ablation. The present study is an exploratory, monocentric, prospective, descriptive study. Three groups of 10 patients with prostate cancer will be evaluated: patients referred for first-line prostate HIFU ablation, patients referred for first-line HIFU hemi-ablation (focal treatment) and patients referred for salvage HIFU after radiotherapy. SWUE will be obtained the day before HIFU ablation (D-1), immediately after HIFU ablation (D0) and the following day (D+1). CEUS will be performed immediately after HIFU ablation and D0 SWUE. The primary endpoint is the comparison of the thickness of undestroyed parenchyma measured by SWUE and CEUS. The secondary endpoints are: - The evolution of shear elasticity within the treated area measured by SWUE at D-1, D0 and D+1, - Adverse events related to SWUE. The study will last 40 months.

NCT ID: NCT01723475 Completed - Prostatic Neoplasms Clinical Trials

First-in-man Dose Escalation Study of BAY2010112 in Patients With Prostate Cancer

Start date: November 2, 2012
Phase: Phase 1
Study type: Interventional

This is the first study where BAY2010112 is given to humans. Patients with castration resistant prostate cancer will be treated. Every patient will receive drug treatment, there is no placebo group. Patients will receive different dosages of BAY2010112 to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY2010112. The study will also assess the pharmacokinetics and the clinical efficacy of BAY2010112. BAY2010112 will be given daily as subcutaneous injection or as continuous intravenous infusion. Treatment will be stopped if the tumor continues to grow, if side effects, which the patient cannot tolerate, occur or if the patient decides to exit treatment.

NCT ID: NCT01718353 Completed - Clinical trials for Prostate Cancer Metastatic

Early Switch From First-Line Docetaxel/Prednisone to Cabazitaxel/Prednisone and the Opposite Sequence, Exploring Molecular Markers in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

TAXYNERGY
Start date: March 2013
Phase: Phase 2
Study type: Interventional

Docetaxel and cabazitaxel are cancer chemotherapy agents of the taxane drug class. The purpose of this study is to explore the benefit, for treatment of metastatic castration-resistant prostate cancer (mCRPC), of a regimen in which participants begin treatment with either of these two taxane drugs (docetaxel or cabazitaxel, in combination with prednisone) and are switched to the other taxane drug if prostate-specific antigen (PSA) value does not decrease ≥30% after 4 cycles. As defined in study protocol amendment 3, efficacy results are summarized for all participants combined, irrespective of which agent (docetaxel or cabazitaxel) was administered initially, rather than separately for the two groups based on taxane administered initially. One of the primary outcome measures is percentage of participants with a ≥50% sustained decrease from baseline in PSA at any time during the trial. By providing an opportunity for patients to switch taxane based on early PSA response, there may be a difference in result for this measure versus result in a study where it was not possible to switch. The other primary outcome measures are change from baseline in circulating tumor cells (CTCs) biomarkers percent androgen receptor nuclear localization (%ARNL) and microtubule bundling (MTB).

NCT ID: NCT01717391 Completed - Prostatic Neoplasms Clinical Trials

[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers

Start date: October 1, 2012
Phase: Phase 2
Study type: Interventional

[F-18] Fluorothymidine PET imaging will be used to create a radiation therapy treatment plan to avoid active bone marrow in the pelvis. This will be done to evaluate if sparing bone marrow will help maintain blood counts. This would impact chemotherapy administration.

NCT ID: NCT01717053 Completed - Prostate Cancer Clinical Trials

Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer

Start date: January 17, 2014
Phase: Phase 2
Study type: Interventional

The addition of abiraterone acetate to standard treatment of radiotherapy and short-term androgen deprivation will increase the frequency of undetectable PSA.

NCT ID: NCT01715285 Completed - Prostate Neoplasms Clinical Trials

A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)

Start date: February 12, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).

NCT ID: NCT01715129 Completed - Prostate Cancer Clinical Trials

Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate Cancer

DKP 3M SC
Start date: January 2013
Phase: Phase 3
Study type: Interventional

Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when administered by subcutaneous route.

NCT ID: NCT01715064 Completed - Prostate Cancer Clinical Trials

Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients

Start date: July 2012
Phase: Phase 2/Phase 3
Study type: Interventional

In Canadian men, prostate cancer (PCa) is the most prevalent form of cancer and the third leading cause of cancer-related death. Unfortunately, PCa survivors are often burdened with feelings of anxiety and depression associated with the disease and associated treatments. Short-term exercise interventions (8-24 weeks) have improved psychosocial well-being in this population, but the impact of single bouts of exercise and related psychological or neurological changes have never been studied. The primary objective of the proposed study is to examine the effect of an acute bout of exercise on neurophysiological and psychological indicators of well-being in a randomized controlled trial (RCT) of 36 men with PCa. Participants will be randomly assigned to the intervention (60 min exercise) or control (60 min of television) and will undergo a brief neurological test (cortical silent period) and psychological questionnaires before and after their group assignment.