A Phase 2, Single-Arm Study of the CXCR1/2 Inhibitor SX-682 Plus Enzalutamide in Men With Abiraterone-Resistant Metastatic Castration Resistant Prostate Cancer, the SYNERGY-201 Trial
The goal of this clinical trial is to study the combination of SX-682 plus enzalutamide in men with metastatic castration resistant prostate cancer (mCRPC) who have failed abiraterone.
NCT06228053 — Metastatic Castration-resistant Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/metastatic-castration-resistant-prostate-cancer/NCT06228053/
Effectiveness of Focal Therapy in Men With Prostate Cancer
In the Netherlands, most men with prostate cancer (PCa) are treated with radical whole-gland treatment, i.e. prostatectomy or radiotherapy. The burden of complications such as incontinence and erectile dysfunction associated with radical treatment is considerable. A recent systematic review by our group has shown that focal therapy of PCa seems to reduce the burden of treatment side-effects in men with intermediate-risk disease, maintaining their quality of life without compromising oncological effectiveness. The costs of side effects that can be prevented are estimated at €5456 per patient, resulting in total expected cost savings of about €22 million per year in The Netherlands. Furthermore, exploration of the benefit-risk balance under patients showed that they are willing to sacrifice some survival for an improvement in quality of life (QoL). Focal therapy comprises a modern alternative to selectively treat a specific part of the prostate while preserving the rest of the gland. There is, however, a lack of high-quality evidence, and numerous papers therefore recommend to perform a multicenter randomized controlled trial (RCT). The RCT should have long-term follow-up, predefined assessment of cancer-specific and health-related QoL outcome measures, and economic evaluations to inform policymakers regarding cost-effectiveness. This RCT on focal therapy versus usual care is urgently needed to enable focal therapy to overgrow the experimental status, provide the evidence needed for guidelines, and make this available for selected patients who benefit from this strategy. Because of its promising results in other countries, focal therapy is increasingly requested by patients, but due to the lack of high-quality evidence, it is not reimbursed yet. This has been designated by both the PCa patient support group and physicians as a failure of both the market and the funding agencies. The investigators, therefore, aim to perform a high-quality multi-center RCT to provide the evidence needed to decide on reimbursement and implementation of focal therapy in patients with intermediate-risk, unilateral clinically localized PCa in the Netherlands.
NCT06223295 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT06223295/
Real-time Image-guided Ultra-hypofractionated Focal Boost to Intraprostatic Lesion(s) With Lymph Node Irradiation for a Very High High-risk Localized Prostate Cancer (the HYPO-RT-PC Boost Trial)
HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer.
NCT06220435 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT06220435/
99mTc-MIP-1404 SPECT/CT for Primary PROstate Cancer STAging: Comparative Prospective, Randomized Trial to Present Guideline Imaging
Prostate cancer (PCa) is currently the most common cancer in men in Finland (www.cancerregistry.fi). Although prognosis is very good in majority of men, it is noteworthy that still up to 20% of PCa cases are metastatic at the time of initial diagnosis and yearly 900 men die because of prostate cancer. Robust primary staging is, therefore, one of the most important prognostic factors, and it is crucial for treatment decision. Despite their low sensitivity to detect metastasis, bone scintigraphy (BS) and contrast enhanced whole body computed tomography (ce-wbCT) are recommended by current guidelines for primary staging in men at risk of metastasis. MIP-1404 is a small-molecule PSMA inhibitor that can be used in SPECT systems (99mTc-MIP- 1404 SPECT/CT). 99mTc-MIP-1404 SPECT/CT is performed by a single IV bolus of 99mTc-MIP-1404, which binds with high affinity to extracellular domain of PSMA molecule. As of March 2020, a total of 629 subjects have received 99mTc-MIP-1404 injection averaging 740 ±111 MBq (20 ± 3 mCi) per administration in prospective clinical trials. 99mTc MIP-1404 has been well tolerated following a single IV dose at 740 ± 111 MBq in both healthy volunteers and patients with confirmed metastatic prostate adenocarcinoma. In prospective and retrospective studies, it has shown high potential to detect prostate cancer lesions in primary staging. In fact, Goffin et al. reported a sensitivity of 50% and specificity of 87% detecting local lymph node metastasis in radically operated patients when histopathology was used as a reference. This corresponds closely to the sensitivity of PSMA-PET. PROSTAMIP is a randomized prospective single-institutional study to demonstrate superiority of 99mTc-MIP-1404 SPECT/CT compared to traditional imaging modalities (99mTc-HMDP planar BS plus ce-wbCT).
NCT06219746 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT06219746/
CHARIOT: A Phase 1b/2 Study of Androgen Deprivation Therapy and Copanlisib in High-Risk Localized Prostate Cancer Patients Prior to Radical Prostatectomy
The researchers are doing this study to find out whether copanlisib in combination with degarelix, given before standard surgical treatment (radical prostatectomy), is a safe and effective treatment that causes few or mild side effects for people who have localized high-risk prostate cancer.
NCT06218667 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT06218667/
Prostate Cancer Geriatric Assessment and Technology Evaluation (ProsGATE) Study
By doing this study, doctors hope to learn more about factors that contribute to frailty (a condition where older adults feel weak, get tired easily, and struggle more with everyday activities) and serious side effects among men over the age of 65 who will receive androgen deprivation therapy (also called "hormone therapy") for prostate cancer that has spread to other parts of their body. Participation in this research will last about 5 years. For the first year, participants will have 5 study visits where they have give blood samples, answer survey questions, and use a wearable device. After study visits are complete, there is a 4-year follow-up period. Research team will check regular doctor visits and look at participants' medical records.
NCT06215508 — Prostate Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/prostate-cancer/NCT06215508/
A Randomized Trial of High-risK metachroNous oligometastatIc Prostate Cancer With hiGh-risk Mutations Treated witH meTastasiS Directed Therapy and Niraparib/Abiraterone Acetate and Prednisone (KNIGHTS)
The purpose of this research study is to compare the effects, good and/or bad, of using the standard of care treatment, hormonal therapy + Stereotactic Ablative Radiation (SABR) to the metastatic lesions, compared to standard of care and addition of 6-months of niraparib/abiraterone acetate combination pills and prednisone for participants with recurrent metastatic prostate cancer.
NCT06212583 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT06212583/
Role of F-18 PSMA PET/CT in Patients With Prostate Cancer: Correlation Between Prostate-Specific Antigen Levels and PSMA PET/CT Scan Findings
It is a cross sectional study aimed to correlate between PSA Levels and F-18 PSMA PET/CT Scan findings and to evaluate the impact of PET/CT findings on the patient management
NCT06209853 — Prostatic Neoplasms
Status: Not yet recruiting
http://inclinicaltrials.com/prostatic-neoplasms/NCT06209853/
Towards Optimal Treatment for High Risk Prostate Cancer; Stereotactic Pelvic Radiotherapy With Focal Boost to the Primary Tumour
The goal of this clinical trial is to combine several optimized treatments of high risk prostate cancer. The main question to answer is: is it safe to combine these optimized treatments. - patients will be irradiated on the prostate and (elective) lymph nodes more concentrated but with fewer hospital visits (hypofractionation) - the tumor will get a higher dose - androgen deprivation therapy will be reduced as much al possible preventing side effects Researchers will compare oncological outcome and toxicity.
NCT06204341 — High Risk Prostate Carcinoma
Status: Not yet recruiting
http://inclinicaltrials.com/high-risk-prostate-carcinoma/NCT06204341/
ARI Treatment Use and Outcomes in Non-metastatic Prostate Cancer (nmPC) Patients in the US
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.
NCT06204302 — Non-metastatic Prostate Cancer
Status: Completed
http://inclinicaltrials.com/non-metastatic-prostate-cancer/NCT06204302/