A Phase I, Open-Label, Dose-Finding Study of TVB-2640 Administered in Combination With Enzalutamide (Xtandi) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The purpose of this study is to determine what effects (good and bad) Enzalutamide and TVB-2640 have in the treatment of prostate cancer whose prostate cancer has spread to other parts of their body and that has not gotten better with previous treatment. This study is a Phase I clinical trial. Phase I clinical trials test the side effects of an investigational drug or an investigational combination with another drug. "Investigational" means that the drug is still being studied and research doctors are trying to find out more about it. Although Enzalutamide is already being used to treat men with prostate cancer, combining Enzalutamide with TVB-2640 together in patients with prostate cancer is considered experimental. This research study is being done because additional effective treatments are needed for prostate cancer that has spread and is growing despite hormone suppression. By doing this study, the investigators hope to learn if combining Enzalutamide with TVB-2640 can be done safely. Participation in this research will last about 12 to 24 months after enrollment.
NCT05743621 — Prostatic Neoplasms, Castration-Resistant
Status: Recruiting
http://inclinicaltrials.com/prostatic-neoplasms-castration-resistant/NCT05743621/
Title Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer Patients - ACTI-PAIR 2 Multicenter, Randomized Stepped-wedge Study
Despite the recognized benefits of physical activity in tertiary prevention, 60-70% of prostate cancer patients are insufficiently active. Yet 150 minutes of brisk walking per week (new WHO recommendations) is associated with a 29% reduction in cancer mortality and a 57% reduction in recurrence. Increasing patients' adherence to regular physical activity appears to be a new challenge for personalized cancer care. Personalized physical activity programmes (1) at home, (2) supported by health professionals, or (3) by peers have shown the effectiveness of regular physical activity. However, these interventions last less than 6 months and do not allow for long-term sustainability of physical activity. This study proposes to combine 3 interventions, which aim to initiate and maintain regular physical activity in prostate cancer patients: - 1-The realization of a personalized and realistic physical activity project via physical activity support devices (sport health centers) - 2-Coaching by a peer (a patient with the same disease who has reached the WHO recommendations for physical activity), who will provide motivational follow-up - 3-Support by health professionals (attending physician) through the prescription of physical activity. The feasibility of ACTI-PAIR program has been demonstrated, the investigators now wish to evaluate it effectiveness.
NCT05739565 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05739565/
The Effects of Prostate Cancer on Brain Function: a Prospective Cohort Study
To explore whether the patients with prostate cancer have functional changes in specific brain areas and changes in psychological and mental characteristics compared with the patients without prostate cancer.
NCT05737004 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05737004/
Dual-frequency Ultrasound for Detection of Prostate Cancer
Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
NCT05736094 — Prostate Cancer
Status: Completed
http://inclinicaltrials.com/prostate-cancer/NCT05736094/
PD-1 Silent PSMA/PSCA Targeted CAR-T for the Treatment of Prostate Cancer
This is a phase I study which will test the safety of different doses of the patients own immune cells which have been changed to help recognize and destroy the cancer cells. The investigators want to find out what effects, good and/or bad, it has on the body and on the prostate cancer. The immune cells (T cells) used in this study will be the patients own immune cells. They will be removed from the patients blood, changed in the laboratory, and then put back into their body. T cells help the body fight infections. These cells may also kill cancer cells in some cases. Right now the patients T cells are unable to kill the cancer cells. For this reason, the physician will change the T cells by putting in a gene so that they may be able to better recognize and kill the prostate cancer cells. A gene is a portion of information which comes from the DNA and tells the cell what to do. This gene will be put into the patients T cells by a weakened virus. It is hoped that this approach will help the T cells recognize the prostate cancer tumor cells and possibly kill them. This is an entirely new treatment for prostate cancer and it is not known if it will have any beneficial or unexpected harmful effects.
NCT05732948 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05732948/
Phase II Trial of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf (HP) Plus Enzalutamide for the Treatment of Selected Patients With Metastatic Castration-Resistant Prostate Cancer (TraPPer)
This phase II trial tests how well pertuzumab, trastuzumab, hyaluronidase-zzxf and enzalutamide works in treating patients with castration-resistant prostate cancer that has spread from where it first started to other places in the body (metastatic). Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called human epidermal growth factor receptor-2 (HER2). HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows pertuzumab and trastuzumab to be given by injection under the skin and shortens their administration time compared to pertuzumab or trastuzumab alone. Chemotherapy drugs, such as enzalutamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pertuzumab, trastuzumab, hyaluronidase-zzxf and enzalutamide may kill more cancer cells.
NCT05730712 — Castration-Resistant Prostate Carcinoma
Status: Recruiting
http://inclinicaltrials.com/castration-resistant-prostate-carcinoma/NCT05730712/
Prospective Study Evaluating the Role of Axumin® (Fluciclovine or 18F-FACBC) PET in Patients With Biochemical Recurrence of Prostate Cancer and a Negative PSMA PET
The purpose of this prospective cohort study is to investigate the role of Fluciclovine Positron Emission Tomography (PET) in patients with biochemical recurrence of prostate cancer (BCR) and a negative Prostate Specific Membrane Antigen (PSMA) PET, specifically, whether Fluciclovine PET can help detect local recurrence and whether the results of Fluciclovine PET can change management.
NCT05722925 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05722925/
Technology-Based Social-Support Intervention Program for Reducing Psychosocial Burden in Prostate Cancer Patients: A Proof-of-Feasibility Pilot Study
The goal of this pilot study is to assess the perceived usability of a smartphone application called WINGS targeting psychosocial distress and well-being in prostate cancer patients and their social network. The main questions it aims to answer are: - How do prostate cancer patients and their social network rate the usability of the technology-based social-support intervention program smartphone application? - Do symptoms of prostate cancer patients improve after using the WINGS smartphone application? - Does the burden of prostate cancer patients social network decrease after using the WINGS smartphone application? Participants will be asked to use the WINGS smartphone application over the period of eight to twelve weeks and fill in questionnaires before, during, and after this time.
NCT05720832 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05720832/
TheraPb: Phase I/IIa Dose Escalation and Toxicity Study of [212Pb]Pb-ADVC001 in Metastatic Prostate Adenocarcinoma
This is a first-in-human, dose escalation and efficacy study of [212Pb]Pb-ADVC001 in participants with PSMA-positive metastatic Castration Resistant Prostate Cancer (mCRPC).
NCT05720130 — Prostatic Neoplasms
Status: Recruiting
http://inclinicaltrials.com/prostatic-neoplasms/NCT05720130/
APalutamide and stEReotactic Body Radiation Therapy for Low Burden Metastatic Hormone senSItive Prostate Cancer, a rANdomized Trial - PERSIAN
Final results from TITAN trial showed that apalutamide plus ADT improved OS in a population of patients with metastatic hormone sensitive prostate cancer (mHSPC), if compared to ADT alone. However, stereotactic body radiotherapy (SBRT) showed to improve outcomes of oligometastatic patients if compared to systemic therapy alone within modern randomized trial, including a mixed cohort of different pathologies. However, there are no trials specifically exploring the benefit offered by SBRT in oligometastatic mHSPC treated with Apalutamide if compared to Apalutamide alone associated to Androgen deprivation therapy. Thus, a randomized trial was designed to test specifically the hypotesis that SBRT will improve outcome in a selected population of oligometastatic mHSPC treated with Apalutamide and ADT, undergoing baseline staging according to local reimbursability.
NCT05717660 — Oligometastatic Hormone Sensitive Prostate Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/oligometastatic-hormone-sensitive-prostate-cancer/NCT05717660/