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Prostatic Neoplasms clinical trials

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NCT ID: NCT03874884 Recruiting - Clinical trials for Metastatic Castration Resistant Prostate Cancer (mCRPC)

177Lu-PSMA-617 Therapy and Olaparib in Patients With Metastatic Castration Resistant Prostate Cancer

LuPARP
Start date: July 9, 2019
Phase: Phase 1
Study type: Interventional

This phase 1 dose-escalation and dose-expansion study is designed to evaluate the safety and tolerability of olaparib in combination with 177Lutetium-Prostate Specific Membrane Antigen (177 Lu-PSMA) in patients with metastatic castration resistant prostate cancer (mCRPC).

NCT ID: NCT03861676 Recruiting - Prostate Cancer Clinical Trials

Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT

Start date: August 3, 2023
Phase: Early Phase 1
Study type: Interventional

The Principal Investigator's (PI) working hypothesis is that the PI can utilize the high predictive value of 18F-DCFPyl PSMA to identify clinically significant tumors in patients who will undergo brachytherapy, as well as areas which are uninvolved or contain only clinically insignificant disease. In the PI's clinical trial, the uninvolved regions (as defined by combined PET-MR-biopsy data) will not be targeted and receive only fall-off dose, which we have shown to be associated with reductions in toxicity.

NCT ID: NCT03861507 Recruiting - Prostate Cancer Clinical Trials

Needle Localization During Prostate Brachytherapy Using Power Doppler Ultrasound

Start date: March 4, 2020
Phase: N/A
Study type: Interventional

This study involves patients who are scheduled for standard care brachytherapy of focal tumours within the prostate, which is normally performed under standard 2-dimensional (2D) ultrasound guidance. The purpose of this study is the acquire power Doppler ultrasound while using a simple oscillator in physical contact with the end of a brachytherapy needle. The vibrations along the needle should be visible in the power Doppler ultrasound, helping to visualize the needle position within the anatomy.

NCT ID: NCT03857113 Recruiting - Prostate Cancer Clinical Trials

Technetium Based Radioguided Surgery for Prostate Cancer (TRACE) Study

TRACE
Start date: March 11, 2020
Phase:
Study type: Observational

PSMA-radioguided surgery

NCT ID: NCT03852654 Recruiting - Clinical trials for Prostate Cancer Adenocarcinoma

18F-DCFPyL PET-CT Scan and Prostate Cancer

Start date: July 22, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Objective: The primary objective of this study is to assess the efficacy of 18F-DCFPyL PET-CT for initial staging of prostate cancer in Veterans compared to conventional imaging (99mTc-MDP bone scan and Diagnostic CT or MRI). The primary clinical endpoint of our study is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging. Secondary Objectives: Frequency of the change in primary treatment plan after initial staging.

NCT ID: NCT03851640 Recruiting - mCRPC Clinical Trials

A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC).

Start date: April 12, 2019
Phase: Phase 3
Study type: Interventional

The study primary objective is to evaluate the effect of HC-1119 soft capsules versus placebo on overall survival (OS) in mCRPC patients who have failed or become intolerant to the treatments with both abiraterone acetate and docetaxel, or who are not suitable for docetaxel treatment.

NCT ID: NCT03845751 Recruiting - Prostate Cancer Clinical Trials

EvaluatioN of HIFU Hemiablation and Short Term AndrogeN Deprivation Therapy Combination to Enhance Prostate Cancer Control.

ENHANCE
Start date: January 2023
Phase: Phase 2
Study type: Interventional

The current study aims to examine the hypothesis that combining the focal effects of HIFU with the systemic effects of androgen deprivation therapy might eradicate the prostatic cancer cells by targeting the 'visible' index focus (by HIFU) and the tumour surrounding microenvironment which may contain 'invisible' foci and aberrant PCa related signalling (by androgen deprivation therapy) to enhance oncological outcomes of HIFU hemi-ablation in men with localized PCa, and consequently reducing treatment failures.

NCT ID: NCT03836196 Recruiting - Prostate Cancer Clinical Trials

Optimizing Prostate Cancer Treatment in Men With Advanced Local Disease

OPTiMAL
Start date: September 13, 2019
Phase: N/A
Study type: Interventional

Multi-modality therapy that includes a brachytherapy implant improves outcomes in locally advanced prostate cancer when compared to other radiation-based treatments, but is also associated with more adverse side effects. The goal of the OPTiMAL trial is to reduce these side effects by using advanced imaging and biopsy techniques to locate cancer and deliver precision radiation therapy, while not compromising the unprecedented high cure rates obtained for the brachytherapy arm of the Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy (ASCENDE-RT) randomized control trial. Additionally, some applied research in genetics, pathology and medical imaging is included. Novel medical imaging methods, namely, multi-parametric magnetic resonance imaging (MRI), multi-parametric trans-rectal ultrasound (TRUS), prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) are used for re-staging of prostate cancer. This is followed by trans-perineal biopsy to locate cancerous areas of the prostate with greater precision compared to conventional biopsy. Results from imaging are compared to those from biopsy to develop image-based cancer detection methods.

NCT ID: NCT03833921 Recruiting - Prostate Cancer Clinical Trials

Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer

APRE
Start date: May 23, 2019
Phase: Phase 2
Study type: Interventional

The investigators are conducting this study with men that have prostate cancer and are getting standard of care treatment with the drugs abiraterone acetate and prednisone. The study will follow men with prostate cancer from initiation of participation in the study and for up to 10 years. The reason for the study is that researchers think that there may be a connection between the race and ethnicity of men with prostate cancer and how well the standard treatments work for the participants.

NCT ID: NCT03830788 Recruiting - Prostate Cancer Clinical Trials

Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy

TEMPOS
Start date: October 4, 2019
Phase: N/A
Study type: Interventional

The TEMPOS-GEniToUrinary Group (GETUG) study is a multicenter, medico-economic study comparing brachytherapy to SBRT in low and intermediate risk prostate cancer, particularly focused on the issue of erectile dysfunction. A total of 240 potent patients are randomized in two arms. The experimental arm consists of SBRT delivering 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. The control arm consists of brachytherapy by Iodine 125 delivering 144 Gy to the prostate. The main objective of this health economics study is to perform a cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy in low-risk prostate cancer, 3 years after treatment. The endpoint is the Incremental Cost-Utility Ratio (ICUR) between SBRT and brachytherapy as primary criterion, expressed in cost per quality adjusted life year (QALY) gained. Cost-effectiveness analyses are performed as secondary objective with Incremental Cost-Effectiveness Ratios (ICERs) expressed as cost per erectile dysfunction avoided and cost per Life Year Gained. A long term evaluation is also performed, including a cost-utility, cost-effectiveness and budget impact analysis at 5 years, a comprehensive assessment of the erectile dysfunction up to 5 years after treatment, an evaluation of acute and late genito-urinary (GU) and Gastro-Intestinal (GI) toxicities, and of quality of life up to 5 years after treatment. Eight patients/year/center are expected to be recruited in 2 years in about twenty participating centers. In total, to our knowledge, this study will be the first health economic evaluation which compares SBRT versus Iodine 125 brachytherapy in low risk and intermediate risk prostate cancer. Both cost-utility and cost-effectiveness analyses will also provide useful and complementary information to decision makers in order (i) to recommend the best strategy to adopt; (ii) to estimate the budget impact on the French National Health Insurance of the generalization of the cost-effective strategy. Finally, this study will allow to assess and compare accurately the erectile dysfunction after both treatment modalities.