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Prostatic Neoplasms clinical trials

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NCT ID: NCT06449664 Recruiting - Prostate Cancer Clinical Trials

Training for Men Undergoing Androgen Deprivation Therapy.

ADT-train
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the effects of a newly developed training concept on men with prostate cancer undergoing androgen deprivation therapy (ADT). The main questions it aims to answer are: - How feasible and safe is the new training concept? - How efficient is the training concept to counteract side effects caused by ADT? Researchers will compare the new training concept with usual care to evaluate how efficient the training concept is to counteract the ADT-related side effects. Participants in the intervention group will perform the new training concept twice weekly for 12 weeks. Participants in the control group will only receive usual care. All participants will visit the laboratory at baseline and after 6 and 12 weeks to measure the primary and secondary outcomes.

NCT ID: NCT06446401 Not yet recruiting - Prostate Cancer Clinical Trials

The Case of "Triple" Versus "Double" Therapy for Patients With High Volume Metastatic Hormone Sensitive Prostate Cancer

Lead4Care
Start date: June 3, 2024
Phase:
Study type: Observational

Lead4Care is an observational, open-label, multicenter study evaluating the effectiveness, tolerance, and cost-effectiveness of triple against double therapy in matched groups of mHSPC patients with high tumor burden. In addition to androgen deprivation therapy (ADT), the triple constitutes of docetaxel and novel hormonal therapy (NHT), and the double of NHT therapy in addition to ADT. Their effectiveness is compared in terms of mortality and morbidity, which is captured by HRQoL, pain, fatigue. Potential side effects are captured by neuropathy, diarrhea, constipation, anxiety, sickness, and dyssomnia. The cost-effectiveness is evaluated within a Markov model from a societal perspective in which the main disease stages are mHSPC, mCRPC and death. In connection with a regular visit in hospital care, prostate cancer patients who in addition to ADT will initiate double or triple therapy are offered participation in the study. If they consent on-line, they will receive 13 online surveys over a 60-month period. The surveys are sent with an interval of two months for the first six months, quarterly thereafter until two years, and thereafter yearly. Once all participants have been recruited, the baseline data shared by healthcare personnel and patients will be enriched with registry data. This baseline and registry data involves information about the patients' historical and current health- and socioeconomic status. Thereby, Lead4Care will be able to identify comparable groups of patients on triple and double treatments by using advanced matching methods. In order to assure an objective analysis, Lead4Care will not allow any data extraction until Lead4Care has predefined and published all details regarding the comparison. The existing protocol is then complemented with information on exactly which patients will be compared across triple and double therapy, and how outcomes will be compared. For these treatments, the main objectives are to: - Compare mortality and morbidity on triple and double therapy, and their relative side-effects. - Capture patient preferences for these different treatment outcomes over time. - Evaluate cost-effectiveness of triple versus double therapy from a societal perspective.

NCT ID: NCT06441994 Recruiting - Prostate Cancer Clinical Trials

Clinical Trial of Targeted Alpha Therapy for Prostate Cancer

Alpha-PS1
Start date: May 24, 2024
Phase: Phase 1
Study type: Interventional

PSW-1025 is administered intravenously to patients with castration-resistant prostate cancer to evaluate its tolerability, safety, pharmacokinetics, absorbed dose, and efficacy, as well as to determine the recommended dose for Phase II.

NCT ID: NCT06441292 Not yet recruiting - Prostate Cancer Clinical Trials

Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

This study is a prospective randomized controlled clinical trial aimed at comparing the detection rates of clinically significant prostate cancer between conventional biopsy methods and AI-assisted biopsy methods in patients undergoing initial prostate biopsy who meet the indications for prostate biopsy.

NCT ID: NCT06439784 Not yet recruiting - Prostatic Cancer Clinical Trials

Contribution of the VERITON-CT Camera in Prostate Bone Radiostereotaxy

VERIOS
Start date: June 15, 2024
Phase: N/A
Study type: Interventional

Stereotactic radiotherapy enables bone metastases to be treated with highly precise irradiation beams, enabling small targets to be irradiated. Planning requires the use of cross-sectional imaging such as computed tomography (CT) or magnetic resonance imaging (MRI). Bone scintigraphy with Tc99m-labelled biphosphonates (T1/2=6h) is indicated in the extension assessment of prostate cancers. Thanks to the advent of single-photon emission computed tomography (SPECT) based on CZT detectors; whole-body SPECT is now compatible with clinical constraints. We propose to study the value of using whole-body SPECT for planning stereotactic radiotherapy of metastatic prostate cancer. This is a prospective, single-center, non-randomized study involving 30 patients. Patients will benefit from routine examinations (CT scan, MRI) including a bone SPECT/CT in treatment position performed on the VERITON-CT (Spectrum Dynamics, Haifa, Israel). Planning based on whole-body SPECT images will be carried out remotely from the patient's point of care. The examination will be interpreted by the nuclear physician, and planning will be based on the dosimetric CT scanner, as in standard management. Virtual replanning will be carried out at distance from treatment, incorporating SPECT imaging. Treatment plans with and without SPECT will be compared quantitatively and qualitatively. The feasibility of SPECT imaging in the treatment position will be assessed, enabling lesion location imaging and dosimetric scanning to be performed in a single examination. All therapeutic management and clinical follow-up will be carried out as part of routine care.

NCT ID: NCT06439225 Not yet recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Platinum and Taxane Chemo in Met Castration Resistant Prostate Cancer Patients With Alterations in DNA Damage Response Genes

OPTION-DDR
Start date: July 31, 2024
Phase: Phase 3
Study type: Interventional

The usual approach for most patients who are not in a study is treatment with docetaxel. This study is being done to answer the following question: Can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual approach? This study is being done to find out if this approach is better or worse than the usual approach for prostate cancer. The usual approach is defined as the care most people get for prostate cancer.

NCT ID: NCT06437574 Not yet recruiting - Prostate Cancer Clinical Trials

Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer

Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

To test the hypothesis that intensive cholesterol lowering (iCL) therapy has anti-tumor immune modulating activity, the investigators will conduct an open-label, single-arm phase II trial in prostate cancer patients who are in active surveillance and undergoing a planned surveillance biopsy in 3-6 months. Eligible patients will initiate iCL with Vytorin®(group 1, 2, and 3), an FDA-approved combination of ezetimibe and simvastatin used to lower atherogenic low density lipoprotein cholesterol (LDL-C) or Ezetimibe (group 4). Starting dose will be determined by current statin use and LDL-C levels. Dose modifications of VYTORIN will be employed with the goal of achieving LDL-C <70 mg/dl. Dose adjustment is not allowed for ezetimibe.

NCT ID: NCT06437496 Recruiting - Clinical trials for Malignant Neoplasm of Prostate

68Ga-AAZTA-093 PET/CT: First-in-human Study

Start date: April 1, 2024
Phase: Early Phase 1
Study type: Interventional

68Ga-AAZTA-093 is a novel radiotracer targeting prostate-specific membrane antigen (PSMA). In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT in patients with prostate cancer.

NCT ID: NCT06435871 Not yet recruiting - Prostate Cancer Clinical Trials

Developing Inclusive Support and Intervention for Spanish-speaking Latiné Prostate Cancer Survivors

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Prostate cancer is a significant concern for Latiné men, with over 17,000 new cases annually. Decision-making for treatment is complex, especially due to barriers like low health literacy and cultural factors. Research on survivorship and post-treatment issues like erectile dysfunction is lacking. To improve care, a study will engage 288 participants across various medical facilities, including 100 at Cleveland Clinic. Thirty subjects will participate in focus groups representing Spanish-speaking Latiné, bilingual Latiné, and English-speaking non-Latiné individuals to understand their perspectives and enhance communication. This aims to develop tailored resources, like Spanish-language educational videos, addressing language and cultural needs for informed decision-making.

NCT ID: NCT06435702 Not yet recruiting - Prostate Cancer Clinical Trials

Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy: A Prospective Observational Cohort Study

Start date: June 1, 2024
Phase:
Study type: Observational

This study is an open, prospective, single-center observational clinical study to evaluate the efficacy and safety of immediate adjuvant ADT with darotarolimide in the treatment of patients with positive lymph nodes after radical prostatectomy for prostate cancer.