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Prostatic Neoplasms clinical trials

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NCT ID: NCT03365518 Completed - Prostate Cancer Clinical Trials

Innovations in the Treatment of Sexual Health Post Prostate Cancer Treatment: Comparing Mindfulness vs. CBT

INTROSPPECT
Start date: December 29, 2017
Phase: N/A
Study type: Interventional

Up to 90% of men experience sexual difficulties after receiving treatment for prostate cancer (PC), which can negatively affect their intimate relationships and overall quality of life. In this randomized clinical trial, the investigators will assess and compare two evidence-based treatments, mindfulness-based therapy and cognitive behavioral therapy (CBT), for couples with sexual complaints following PC treatment to controls who will receive no intervention.

NCT ID: NCT03365297 Completed - Prostate Cancer Clinical Trials

Therapeutics in Active Prostate Cancer Surveillance

TAPS01
Start date: June 5, 2018
Phase: Phase 2
Study type: Interventional

Testing if short-term use of apalutamide can reduce image defined tumour volumes in men with detectable lesion on multi-parametric Magnetic Resonance Imaging (mpMRI) and being managed by Active Surveillance. The trial will also evaluate the tolerability and side effect profile of men on AS using short term apalutamide and patient acceptability as a therapeutic strategy, as well as determining feasibility of a larger prospective randomised trial of apalutamide.

NCT ID: NCT03362359 Completed - Prostate Cancer Clinical Trials

Ga-68-PSMA-11 in High-risk Prostate Cancer

Start date: October 9, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This will be an open-label, single-arm, rater-blinded, multicenter, diagnostic phase 1/2 study to assess safety and diagnostic performance of Ga-68-PSMA-11 positron emission tomography / computer tomography (PET/CT) imaging to detect tumour tissue in patients with newly diagnosed PCA and a high risk for metastasis. As standard of truth, comprehensive histopathology covering prostate and the tributary pelvic lymph node system, will be used. Therefore, only patients scheduled for RP with EPLND (as part of their standard of care) will be eligible. Patients will be recruited at up to 11 uro-oncological sites in Germany, Austria, and Switzerland, with access to a radiopharmaceutical laboratory, experienced to prepare 68Ga-labelled compounds, and high-quality PET/CT imaging. Upon histological confirmation of PCA, pre-operative staging will be performed according to European Association of Urology (EAU) guideline [Mottet et al. 2015] (to include pelvic MRI or CT and a 99mTc-bone scan), to establish the indication for RP with EPLND. If the indication is confirmed, patients will be invited to participate in the present study. After consenting, review of inclusion and exclusion criteria, as well as screening investigations will be performed by the uro-oncologist (day 0). Thereafter, patients are referred to the collaborating nuclear medicine department for tracer injection, imaging, and post-dose safety evaluations (day 1). Subsequent investigations (day 2 and at end of study) will be made by the uro-oncologist or experienced nuclear medicine physician. Study participation ends on day 7. Routine surgery (RP with EPLND) will be performed after end of study, but no later than 42 days after study inclusion. This sequence allows adequate characterisation of tracer safety, while at the same avoiding unnecessary delay of, or confounding safety signals from therapy. In total, 150 evaluable patients will be included to receive a single 68Ga dose of 150 MBq (± 50 MBq), administered as i.v. infusion. Due to an assumed dropout rate of 15%, up to 173 patients will be included in study.

NCT ID: NCT03361969 Completed - Prostatic Neoplasm Clinical Trials

Evaluation of Effects of Estetrol on Testosterone Suppression and Quality of Life in Prostate Cancer Patients Treated With an LHRH Agonist.

Start date: April 16, 2018
Phase: Phase 2
Study type: Interventional

This is a phase IIa, double-blind, randomised, placebo-controlled, multi-center study to evaluate the effects of estetrol on testosterone suppression and quality of life in prostate cancer patients treated with an LHRH agonist. Patients will be treated with estetrol or placebo for 6 months.

NCT ID: NCT03358563 Completed - Prostate Cancer Clinical Trials

Pilot Trial of Chemohormonal Therapy Followed by Prostatectomy in High Risk Prostate Cancer

Start date: January 17, 2018
Phase: Early Phase 1
Study type: Interventional

This is a pilot multimodality treatment approach trial with androgen deprivation therapy in combination with docetaxel chemotherapy followed by radical prostatectomy in patients with newly diagnosed high-risk and oligometastatic prostate cancer. This study aims to evaluate the rates of complete pathologic response (pCR) at the time of prostatectomy as well as PSA response, time to PSA recurrence and safety and toxicity of the combination. This study will be heavily embedded with biomarker analyses of the tumor and tumor cells in circulation as well in the bone marrow before and after treatment and will also include imaging analyses using a novel positron emission tomography (PET) imaging technology.

NCT ID: NCT03348722 Completed - Prostatic Neoplasm Clinical Trials

Active Surveillance or Radical Treatment for Newly Diagnosed Patients With a Localized, Low Risk, Prostate Cancer START

START
Start date: May 15, 2015
Phase:
Study type: Observational

The purpose of the START project is to evaluate the acceptability, the safety and the cost-effectiveness of a population based program of active surveillance for patients newly diagnosed with a localized, low risk, prostate cancer.

NCT ID: NCT03348527 Completed - Prostate Cancer Clinical Trials

A Study to Evaluate the Safety, Tolerability and Efficacy of a Liproca® Depot Injection in Patients With Prostate Cancer

Start date: May 12, 2017
Phase: Phase 2
Study type: Interventional

A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection into the Prostate in Patients with Localized Prostate Cancer,Assigned to Active Surveillance who are at High Risk for Disease Progression (followed by an Open Label Extension with a Repeat Injection (Optional))

NCT ID: NCT03343093 Completed - Prostatic Neoplasm Clinical Trials

Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Development and evaluation of an online intervention addressing sexual functioning in gay and bisexual men (GBM) after prostate cancer treatment.

NCT ID: NCT03339531 Completed - Prostate Cancer Clinical Trials

Optimized 2D-RT for Prostate Cancer

Start date: February 2, 2015
Phase: N/A
Study type: Interventional

Prostate cancer (CAP) is one of the most common malignancies in men, both in Western countries and developing countries. Radiation therapy (RT) is an important therapeutic option. New technologies (3D, IMRT, IGRT, VMAT) have been introduced in the last decades, with a progressive improvement of clinical outcome. However, in many countries the only treatment option is the traditional 2D technique based on standard simulation. The indications for field definition in this treatment are still based on expert's opinions. The aim of this analysis is to propose new indications for 2D fields definition based on three-dimensional simulation in a population of patients with CAP. Twenty patients with CAP consecutively treated with RT in our center were identified. Patients underwent CT-simulation in supine position. Pelvic MRI images were fused with CT-simulation images. In this way, delineation of the prostate and seminal vesicles was performed on MRI images. Clinical Target Volume definition (CTV) was performed according to EORTC guidelines simulating 4 different categories: low-risk CAP, intermediate-risk CAP, high-risk CAP without involvement of the seminal vesicles, and high-risk CAP with involvement of seminal vesicles. The Planning Target Volume (PTV) was defined by adding a margin of 10 mm to the CTV in all directions. For each patient, 8 treatment plans were calculated. In particular, for each of the 4 categories of risk, 2 treatment plans were calculated by using a cobalt source or 10 MV photons. Treatment plans were calculated using the box technique. Progressive optimization was realized with an iterative procedure by evaluating the three-dimensional dose distribution. Once the final plan was achieved (respecting the PTV constraint: D98 > 95%), distances of the fields edges from a set of reference points were measured.

NCT ID: NCT03335631 Completed - Prostate Cancer Clinical Trials

Preference-Based Exercise RCT for Men With PC on ADT

PBExRCT
Start date: October 19, 2017
Phase: N/A
Study type: Interventional

Prostate cancer affects 1 in 7 men. Half of these men are treated with androgen deprivation therapy (ADT). ADT slows disease progression and prolongs survival, but it also leads to worse quality of life (QOL), fatigue, loss of strength and fitness, osteoporosis, and diabetes. The investigators' recent research has shown that individually supervised exercise, supervised group exercise and home-based exercise are equally good at improving these side effects. Now the investigators are doing a larger trial with multiple centres to see whether supervised group or home-based exercise is clinically better and more economical. A major challenge in such trials is that a significant number of men refuse to be randomized because (a) the participant lives too far from a study centre and cannot come for supervised exercise; or (b) the participant has a strong preference as to which type of exercise program the participant wants to do. Experts have raised concerns that classic randomized trials are too restrictive, selective, and less practical; the study results are less applicable to the real world. Despite its obvious importance, it is not known whether men who refuse to be randomized to an exercise trial but are otherwise willing to participate would benefit similarly to men who are randomized. In this study, we will recruit men who are otherwise eligible for our randomized trial but refuse it for one of the reasons above. We will allow these men to choose either supervised group or home-based exercise, and then compare them to the men who are being randomized to the two treatments in 3 important ways. First, are participants similar in terms of personal characteristics, QOL, and fitness levels? Second, do participants respond similarly to exercise in terms of QOL and physical fitness benefits? Third, do participants actually exercise as much as the randomized men? This work will help the research team understand whether there is a need to change the way exercise trials are done in order to be more relevant and wide-reaching for Canadians with a variety of health conditions.