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Non-Metastatic Prostate Cancer clinical trials

View clinical trials related to Non-Metastatic Prostate Cancer.

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NCT ID: NCT06204302 Completed - Clinical trials for Non-metastatic Prostate Cancer

An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States

ARENA
Start date: January 5, 2024
Phase:
Study type: Observational

This is an observational study in which data will be collected and studied from men with non-metastatic prostate cancer (nmPC) who received their usual treatment with 'androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide. Prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. Non-metastatic means that cancer has not yet spread to other parts of the body. Darolutamide, enzalutamide, and apalutamide are already approved ARIs for nmPC in the United States (US). They work by blocking androgens (male sex hormones including testosterone) from attaching to proteins in cancer cells in the prostate. This helps to slow down the growth of the cancer cells. The participants will receive their treatments as prescribed by their doctors during routine medical care according to the approved product information. Researchers want to know more about the use of ARIs and how they affect men with nmPC in the real world. Researchers will only include men who have not been treated with any new type of medication that blocks the action of male sex hormones. The main purpose of this study is to collect and study information from men with nmPC about: - the length of time they continued treatment with an ARI as prescribed by their doctors. - the length of time from the start of the treatment with an ARI until the cancer spreads to other parts of the body. Data will come from the participants' information stored in a database called Komodo Research Dataset (KRD) in the US. The data collected will be from May 2019 to June 2023. Researchers will only track data of eligible US men with nmPC and will follow them for a minimum of 6 months or until the end of the study.

NCT ID: NCT06202248 Recruiting - Clinical trials for Non-metastatic Prostate Cancer

A Study to Assess Alpha DaRT224 for the Treatment of Men With Non-metastatic Locally Recurrent Prostate Cancer

Start date: March 12, 2024
Phase: N/A
Study type: Interventional

This is a multi-center clinical study enrolling up to 10 participants. The purpose of this study is to assess the feasibility and safety of intratumoral DaRT seeds implantation for the treatment of locally recurrent prostate cancer. Secondary objectives are to 1. To evaluate feasibility of interstitial radiotherapy using DaRT seeds. Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging [Timeframe: immediately following the insertion procedure 2. To assess the impact of DaRT seeds on patient reported quality of life.

NCT ID: NCT05617885 Active, not recruiting - Prostate Cancer Clinical Trials

Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

Start date: August 9, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This research study is trying to determine the safety and efficacy of the combination of two oral drugs, abemaciclib and darolutamide, with androgen deprivation therapy (ADT) in the treatment of metastatic, non-metastatic, and advanced prostate cancers. The first phase of the study is to establish a recommended dose for the second phase. The names of the study drugs and interventions involved in this study are: - Darolutamide - Abemaciclib - Androgen deprivation therapy (ADT) - this includes several different treatments, including Gonadotropin-Releasing Hormone (GnRH) antagonists and agonists It is expected that about 93 people will take part in the research study. Treatment is expected to last 6 months with a follow up period of up to 4.5 years.

NCT ID: NCT04400656 Completed - Prostate Cancer Clinical Trials

PROState Pathway Embedded Comparative Trial

IP3-PROSPECT
Start date: September 8, 2020
Phase:
Study type: Observational

The proposal will explore a trial design called the cohort-multiple RCT (cmRCT) or as it has been recently coined, the Trials WithIn Cohorts (TWICS) design. This design has been used in a number of disease areas, both benign and cancer. Prostate conditions have been chosen since they are extremely common and if malignancy occurs the majority of men with the disease are regarded as living with a chronic condition due to its long natural history and in which innovative approaches, interventions, treatments or changes in management might have a significant patient benefit and impact on the NHS. It therefore fits the cmRCT design very well. Nonetheless, the lessons learned in this study will be of relevance to other disease spaces. The TWICS or cmRCT design is currently being used in elderly patients, risk of falls, depression, hip fracture, Yorkshire Health Study, scleroderma, breast cancer, colorectal cancer, bladder cancer and kidney cancer, to name a few. In total, a recent systematic review showed that there were 18 ongoing cmRCT studies with 6 in the UK. The acceptability and feasibility of the cmRCT in the prostate pathway will be tested. This is the first time this method will be tested and therefore piloted. In the first part of the study, the following will be evaluated. What is the accrual rate? What do patients and their healthcare professionals think of the cmRCT design? Is the data collected robust? What are the resource requirements of such a study?A number of novel interventions or changes in the pathway will then be tested and compared to standard care in the cohort that was recruited.

NCT ID: NCT04049747 Recruiting - Prostate Cancer Clinical Trials

Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer

IP4-CHRONOS
Start date: December 11, 2019
Phase: N/A
Study type: Interventional

Men diagnosed with significant cancer confined to the prostate currently undergo radical therapy directed to the whole prostate (radiotherapy or prostatectomy). These provide good cancer control but can cause significant side effects. Focal Therapy involves targeting the cancer alone, whilst leaving healthy prostate gland alone. Case series have shown similar cancer control over 5 years with a much better side effect profile. However, there have been no randomised control trials (RCTs) comparing the success in cancer control and the quality of life in patients that undergo radical therapy vs those that undergo focal therapy. Further, there is a need to assess the use of additional therapies that may improve the cancer control outcomes following focal therapy. By having a trials platform with two RCTs (CHRONOS-A and CHRONOS-B) that reflect best patient and physician preferences/ equipoise, the investigators aim to answer these questions. To improve acceptability, recruitment and compliance, the investigators have an embedded study aimed at reviewing clinician and patient perspectives and trial acceptability. CHRONOS-A will compare radical therapy to focal therapy, whilst CHRONOS-B will compare focal therapy alone to focal therapy with various therapies targeting the testosterone pathway that can shrink the cancer before it is treated. The investigators think this might improve outcomes further for men that definitely want focal therapy.

NCT ID: NCT01317043 Recruiting - Clinical trials for Non-metastatic Prostate Cancer

A Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy

0622
Start date: July 2007
Phase: Phase 2
Study type: Interventional

The pupose of this study is to assess the effectiveness of Samarium 153 administration, as determined by a 30% decline in the PSA within 12 weeks, as compared to baseline, in a population of men with high risk, clinically non-metastatic prostate cancer after a radical prostatectomy.

NCT ID: NCT00673205 Completed - Clinical trials for Non-Metastatic Prostate Cancer

(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer

Capri
Start date: September 1995
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.

NCT ID: NCT00672282 Completed - Clinical trials for Non-Metastatic Prostate Cancer

Casodex vs Placebo in Non-Metastatic Early Prostate Cancer

SPCG6
Start date: October 1995
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.

NCT ID: NCT00657904 Completed - Clinical trials for Non-metastatic Prostate Cancer

Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer

Start date: August 1995
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.

NCT ID: NCT00239291 Completed - Clinical trials for Non-Metastatic Prostate Cancer

Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer

Start date: January 2003
Phase: Phase 1/Phase 2
Study type: Interventional

To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer