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Prostate Cancer clinical trials

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NCT ID: NCT02793765 Withdrawn - Prostate Cancer Clinical Trials

Docetaxel Followed by Provenge in Metastatic Prostate Cancer

Start date: December 2016
Phase: Phase 2
Study type: Interventional

This clinical study will evaluate the role of combination therapy of docetaxel followed by Provenge for patients with metastatic castration-resistant prostate cancer (CRPC, (prostate cancer that is resistant to medical or surgical treatments that lower testosterone). The purpose of this study is to look at the combination therapy of docetaxel followed by Provenge to correlate the immunological biomarkers with clinical results for therapy. Biomarkers are genes, proteins and other molecules that affect how cancer cells grow, multiply, die and respond to other compounds in the body. The study drugs are approved by the Food and Drug Administration (FDA). Treatment will be administered on an outpatient basis. Patients will receive 6 cycles of docetaxel followed by Provenge. Docetaxel is an antineoplastic (chemotherapy that affects cancer cell growth) agent. Docetaxel dose of 75 mg/m2 will be given intravenously as a 1-hour infusion every 21 days on Day 1 for 6 cycles. Provenge is an immunotherapy (vaccine made from patient's own blood cells) that reprograms immune cells to attack cancer. A course of therapy consists of three doses of Provenge administered at 2-week intervals. The strategy aims to determine whether cytokine production and T cell infiltration of tumor cells could favor regression using a combination of chemotherapy plus vaccine. Tissue endpoints will include biopsies prior to first chemotherapy and first vaccine therapy and at the end of each therapy. Prostate cancer tissue infiltrates will be studied for expression of CD3, CD4, CD8, CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological endpoints will be secondary antigen spread and various cytokine biomarkers.

NCT ID: NCT02793219 Withdrawn - Prostate Cancer Clinical Trials

Provenge Followed by Docetaxel in Castration-Resistant Prostate Cancer

Start date: December 2016
Phase: Phase 2
Study type: Interventional

This clinical study will evaluate the role of combination therapy of Provenge followed by docetaxel for patients with metastatic castration-resistant prostate cancer (CRPC, (prostate cancer that is resistant to medical or surgical treatments that lower testosterone). The purpose of this study is to look at the combination therapy of Provenge followed by docetaxel to correlate the immunological biomarkers with clinical results for therapy. Biomarkers are genes, proteins and other molecules that affect how cancer cells grow, multiply, die and respond to other compounds in the body. The study drugs are approved by the Food and Drug Administration (FDA). Treatment will be administered on an outpatient basis. Patients will receive Provenge followed by 6 cycles of docetaxel. Provenge is an immunotherapy (vaccine made from patient's own blood cells) that reprograms immune cells to attack cancer. A course of therapy consists of three doses of Provenge administered at 2-week intervals. Docetaxel is an antineoplastic (chemotherapy that affects cancer cell growth) agent. Docetaxel dose of 75 mg/m2 will be given intravenously as a 1-hour infusion every 21 days on Day 1 for 6 cycles (21 days). The strategy aims to determine whether cytokine production and T cell infiltration of tumor cells could favor regression using a combination of vaccine plus chemotherapy. Tissue endpoints will include biopsies prior to vaccine therapy and chemotherapy and at the end of therapy. Prostate cancer tissue infiltrates will be studied for expression of CD3, CD4, CD8, CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological endpoints will be secondary antigen spread and various cytokine biomarkers.

NCT ID: NCT02678520 Withdrawn - Prostate Cancer Clinical Trials

Clinical Trial Comparing 3-D RT vs. IMRT in Post- Prostatectomy Prostate Cancer Patients

Start date: December 2015
Phase: Phase 2
Study type: Interventional

Compare the incidence of acute rectal, bladder and other acute toxicities between 3-D Conformal Radiation Therapy (RT/CRT) and Intensity Modulated Radiation Therapy (IMRT) in Post-Prostatectomy Prostate Cancer Patients treated with post-operative radiation therapy

NCT ID: NCT02656563 Withdrawn - Prostate Cancer Clinical Trials

Radium 223 Following Intermittent ADT

RAND
Start date: October 2015
Phase: Phase 2
Study type: Interventional

This is a multicentre, phase II, randomized, open label study to evaluate the efficacy and safety of monthly Radium 223 in prolonging the off treatment interval of men with localized prostate cancer receiving intermittent androgen ablation therapy for a rising PSA post-radiation or post-prostatectomy, who are at high risk for occult metastases.

NCT ID: NCT02645591 Withdrawn - Prostate Cancer Clinical Trials

Randomized AmnioFix Study During Radical Prostatectomy

Start date: November 2016
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn about the safety and the effectiveness of using AmnioFix® (dehydrated human amnion/chorion membrane, also called dHACM) to help improve the return of erectile function and bladder control in patients after robotic assisted laparoscopic radical prostatectomy (RARP). dHACM is a section of tissue made from part of the placenta donated by a mother during a C-section. It looks like a small piece of tissue paper and is wrapped around the nerve bundles in the surgical area. The tissue may help the body's normal healing process.

NCT ID: NCT02621684 Withdrawn - Prostate Cancer Clinical Trials

Physical Activity Intervention in African American Men After Radical Prostatectomy

Start date: November 2014
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to evaluate the feasibility of recruiting African American prostate cancer survivors to a 12 week physical activity intervention study of three arms (aerobics, resistance training, and usual care) through physician referral and community advertisement strategies. In addition, the investigators will investigate the acceptance rate of the intervention and gather preliminary results on the effect of exercise on African American men's urinary and sexual functions. These data can then be used to refine the intervention and its implementation model, and to inform the submission of a larger grant to the National Institutes of Health.

NCT ID: NCT02608359 Withdrawn - Prostate Cancer Clinical Trials

A Post-marketing Surveillance to Assess Safety of Abiraterone Acetate (Zytiga) in Indian Participants With Metastatic, Castration Resistant Prostate Cancer

Start date: May 31, 2016
Phase:
Study type: Observational

The purpose of this study is to evaluate the safety of abiraterone acetate in Indian participants with metastatic, castration-resistant prostate cancer who have been prescribed abiraterone acetate as per locally approved prescribing information.

NCT ID: NCT02588846 Withdrawn - Prostate Cancer Clinical Trials

Multi-target Tracking in Prostate Radiotherapy Using MLC and KIM

KOALA
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Assessing the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to account for the relative motion of the moving prostate tumour target and the static pelvic nodal target for high-risk prostate cancer patients. The capability of tracking for the relative motion of multiple targets will ensure that all the treatment targets receive correct dose as prescribed by the doctor and minimise side effects to the critical organs.

NCT ID: NCT02546427 Withdrawn - Prostate Cancer Clinical Trials

Hypofractionated Whole Pelvic Radiotherapy of the Prostate

Start date: December 9, 2016
Phase: N/A
Study type: Interventional

This is a phase I feasibility study to evaluate the feasibility of hypofractionated whole pelvis radiotherapy in 35 patients with biopsy-proven intermediate- to high-risk prostate cancer as defined by NCCN risk criteria. Patients will have >15% risk of lymph node involvement as defined by the Roach equation 2/3(PSA)+10(Gleason Score-6). Day 0 of the study will be defined as the time of first LHRH/agonist/antagonist injection of hormone therapy. Radiation therapy should begin within 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection. Patients will be followed at 6 weeks and then every 3 months for the first 24 months after completion of radiotherapy in a similar schedule to usual standard of care. A history and physical, PSA, testosterone and EPIC-26 questionnaire will be collected at each visit. Any toxicity according to CTCAE v. 4.0 criteria will be documented. An interim analysis for evaluating acute toxicity (≤90 days) will be performed after the first follow-up visit of the20th patient enrolled on protocol. The trial will be terminated if >30% acute grade 2 or >5% grade 3 or greater toxicity is observed as a result of radiation treatment by CTCAE v. 4.0 criteria. Grade 2 toxicity is defined as a minimal, local or noninvasive intervention. Grade 3 toxicity is defined as a severe or medically significant but not immediately life-threatening event requiring hospitalization or prolongation of hospitalization. Previous studies have demonstrated approximately 30% and 5% incidence of Grade 2 and Grade 3 or greater toxicity, respectively, with conventionally fractionated radiotherapy followed by brachytherapy.

NCT ID: NCT02538432 Withdrawn - Breast Cancer Clinical Trials

Phase II Trial of EP4 Receptor Antagonist, AAT-007 (RQ-07; CJ-023,423) in Advanced Solid Tumors

Start date: June 2017
Phase: Phase 2
Study type: Interventional

This is a phase II trial of (RQ-07) in advanced solid tumors in prostate, breast or non-small cell lung cancer.