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Prostatic Neoplasms clinical trials

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NCT ID: NCT04644770 Recruiting - Prostatic Neoplasms Clinical Trials

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

Start date: November 12, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of JNJ-69086420 in Part 1 (Dose Escalation) and to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion).

NCT ID: NCT04644068 Recruiting - Breast Cancer Clinical Trials

Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

PETRA
Start date: November 12, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.

NCT ID: NCT04642833 Recruiting - Prostate Cancer Clinical Trials

Prostate Cancer in Renal Transplants Recipients

RENPRO
Start date: November 18, 2020
Phase:
Study type: Observational

Kidney transplantation is considered the standard of care for patients with end-stage kidney disease under chronic dialysis treatment. Today, modern surgical techniques have dramatically improved the quality of life and the overall survival of renal transplant recipients (RTRs) . Besides, the use of novel immunosuppressors have increased the 1-year graft survival rate and decreased acute rejection rate . Unfortunately, several transplantation-related diseases including cancer, cardiovascular disease and infection may affect the survival of renal transplant recipients. It has been estimated that RTRs are 2- to 5- fold more likely to develop cancer compared to the general population. Therefore, the development of cancer has become a major concern as it is currently one of the main causes of death in RTRs. The increasing incidence of post-transplant malignancies is generally attributed to immunosuppression which leads to impaired immunosurveillance of cancer cells and virals infections capable of cancer development. Additionally, it has been observed a direct and specific pro-oncogenic effect on RTRs of immunosuppressive drugs and other immunosuppression-independent factors such as the increased age of RTRs, the male gender and the pre-transplant dialysis duration . Prostate cancer is the second most diagnosed cancer in men and the most common non-skin solid neoplasm in RTRs. Generally, the vast majority of post kidney transplantation prostate cancers are localised; however, due to the lack of randomized studies, no specific guidelines for the management of localized prostate cancer are available and, consequently, RTR patients are being treated with surgery or radiotherapy according to national or local guidelines. The concomitant use of immunosuppressors and the presence of the kidney graft in the pelvic cavity make the treatment of localised prostate cancer post kidney transplantation more challenging, highlighting the need for these patients to be addressed to urological oncology centres with surgeons familiar with oncological and transplant surgery. Prostate cancer is the second most diagnosed cancer in men and the most common non-skin solid neoplasm in RTRs, however, little studies describe the real incidence of prostate cancer in RTRs. The aim of this study is to retrospectively review a 25-year experience at the Florence Transplant Center in order to evaluate the incidence of prostate cancer and its possible clinical/pathological factors able to influence the survival.

NCT ID: NCT04642027 Recruiting - Prostate Cancer Clinical Trials

PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy

PERYTON
Start date: September 1, 2020
Phase: Phase 3
Study type: Interventional

After radical prostatectomy approximately 15-40% of men develop a biochemical recurrence (BR) within 5 years. The standard treatment of post-prostatectomy BR is salvage external beam radiation therapy (sEBRT). sEBRT can provide long-term disease control; with 5 year biochemical progression-free survival (bPFS) up to 60% and with most treatment failures in the first 2 years after sEBRT. The main goal of this project is to investigate whether the oncologic outcome in patients with post-prostatectomy recurrent PCa can be improved, by increasing the biological effective radiation dose using a hypofractionated schedule of 20 x 3 = 60 Gy. The study is designed as a prospective open phase III randomized multicenter trial. All patients with biochemical recurrence with a PSA < 1.0 ng/ml after radical prostatectomy for prostate cancer without evidence of lymph nodes or distance metastases will be included. PSA progression after prostatectomy defined as two consecutive rises with the final PSA > 0.1 ng/mL or three consecutive rises will be included. All eligible patients will be randomized to one of the following two treatment arms: Arm 1 = Conventional sEBRT to apply a total dose of 70 Gy in 35 daily fractions of 2 Gy during 7 weeks. Arm 2 = Hypofractionated sEBRT to apply a total dose of 60 Gy in 20 fractions of 3 Gy during 4 weeks. The primary endpoint will be the 5-year progression-free survival (PFS) after treatment.

NCT ID: NCT04641078 Recruiting - Prostate Cancer Clinical Trials

Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer

DART
Start date: February 12, 2021
Phase: Phase 2
Study type: Interventional

The current trial will test the combination of darolutamide with SBRT, in oligometastatic recurrent hormone sensitive prostate cancer. We hypothesize that the addition of short-term darolutamide improves metastasis-free survival when added to SBRT without a detrimental impact on the QoL. Considering the large reluctance of both patients and physicians to be randomized to observation, we propose to use the historical data from previous reported randomized trials (STOMP and ORIOLE) as a comparator to explore as a secondary endpoint.

NCT ID: NCT04638088 Recruiting - Prostate Cancer Clinical Trials

Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy

EMUPRO
Start date: March 1, 2021
Phase:
Study type: Observational

Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.

NCT ID: NCT04633252 Recruiting - Prostate Neoplasms Clinical Trials

M9241 in Combination With Docetaxel in Adults With Metastatic Castration Sensitive and Castration Resistant Prostate Cancer

Start date: February 23, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Metastatic castration sensitive and castration resistant prostate cancer (mCSPC and mCRPC) are prostate cancers that have spread to other parts of the body. Use of the drug docetaxel with androgen deprivation therapy can improve survival for men with mCSPC. Researchers want to see if combining this treatment with other drugs can help delay the time it takes for mCSPC and mCRPC to get worse. Objective: To learn if giving docetaxel with M9241 is safe and effective for men with prostate cancer. Eligibility: Men age 18 and older with mCSPC or mCRPC. Design: Participants will be screened with a medical history and physical exam. Their diagnosis will be confirmed. Their symptoms and how well they do their normal activities will be reviewed. They will have blood and urine tests. Their heart will be evaluated. They will have imaging scans of the chest, abdomen, and pelvis. They will have bone scans with intravenous (IV) injections of Tc99 to check for tumor spread in the bones. Some screening tests will be repeated during the study. Participants may have tumor biopsies. Participants will get treatment in cycles. Each cycle will last 21 days. They will get docetaxel through IV infusion. They will get M9241 as an injection under the skin. Participants with mCSPC will have up to 6 cycles. Those with mCRPC will be treated until they cannot tolerate the side effects or their disease gets worse. Participants will have a follow-up visit 30 days after treatment ends. Those with mCSPC will then have follow-up visits at the clinic every 3 months.

NCT ID: NCT04632251 Recruiting - Prostate Cancer Clinical Trials

Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer

LPM-012
Start date: September 16, 2020
Phase: N/A
Study type: Interventional

This study is a prospective, open label, single-arm study to examine the performance and safety of the SENSEI® laparoscopic tethered gamma probe in patients undergoing 99mTc-nanocolloid SLNB for prostate cancer (PCa) during RP and ePLND surgery. Patients scheduled for RP and ePLND using the standard treatment pathways at each centre will have preoperative 99mTc-nanocolloid imaging. RP and ePLND will be conducted as standard of care, with SLNB guided by the SENSEI® laparoscopic tethered gamma probe carried out after RP and prior to ePLND. The first 2 patients per site (N = 10 in total) are considered to be sufficient to enable further familiarisation with the procedure and use of the probe in addition to the usability work and training that the sites did prior to the start of this study. Subsequent patients will be evaluable for the PP population. The primary analysis of diagnostic performance will be performed using the PP population of patients with SLN identified on preoperative imaging

NCT ID: NCT04631744 Recruiting - Prostate Cancer Clinical Trials

Cabozantinib in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Start date: March 3, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine what effects (good and bad) cabozantinib has in treatment of patients with metastatic castrate resistant prostate cancer (mCRPC). The hypothesis for this trial is that cabozantinib has anti-tumor activity in a molecularly-selected group of patients with CRPC.

NCT ID: NCT04627948 Recruiting - Prostate Cancer Clinical Trials

STHLM3 AS NorDCaP - a Followup Study of Men on Active Surveillance of Prostate Cancer

NorDCaP AS
Start date: July 1, 2019
Phase:
Study type: Observational

The aim of the STHLM3 AS NorDCaP study is to evaluate the Stockholm3 test in an active surveillance cohort to predict upgrading on rebiopsy. The study follows a paired design, evaluating our proposed protocol for follow up men on active surveillance with Stockholm3 versus the standard protocol according to national guidelines with PSA.