Prostate-Specific Antigen (PSA)

Researchers are evaluating the use of lutetium (177Lu) vipivotide tetraxetan, administered as a single dose, as a systemic adjuvant treatment for adult men with high or very high risk prostate cancer. This phase 2 clinical trial focuses on patients who have completed radical locoregional teleradiotherapy and hormone therapy and show no signs of cancer spread in recent radiological exams. The study aims to assess treatment effectiveness and progression-free survival over a long follow-up period. Participants are randomly assigned to one of two groups: one receiving a single administration of 7.4 GBq of 177Lu-PSMA alongside standard hormone therapy, and the other receiving hormone therapy alone. The intervention phase lasts one day, after which participants enter a five-year observation phase to monitor outcomes and safety. Both groups continue with standard hormone therapy throughout the study. During the study, researchers will conduct regular assessments including biochemical and radiological evaluations to track cancer progression, quality of life measures, and adverse events. The primary outcome is treatment effectiveness measured at two and five years after treatment. Participants will be monitored for up to five years to observe progression-free survival, time to next therapy, and overall health status. The study is sponsored by the Maria Sklodowska-Curie National Research Institute of Oncology.

Researchers are evaluating the safety and effects of combining a targeted radionuclide therapy called 177Lu-PSMA-617 with liver-directed treatments in men who have metastatic castration-resistant prostate cancer (mCRPC) with liver metastases. This phase 1b open-label study focuses on patients whose cancer has progressed despite prior androgen pathway inhibitor treatments. The study aims to understand how well this combined approach controls disease and its safety profile using standard response criteria. Participants receive up to six cycles of 177Lu-PSMA-617 intravenously every 6 weeks. Those with PSMA-negative liver lesions receive a single session of liver-directed therapy such as transarterial chemoembolization (TACE) or ablation before starting the radionuclide treatment. If liver disease remains stable or progresses after two cycles, additional liver-directed therapy may be given. Treatment continues until disease progression, unacceptable side effects, or study completion. During the study, participants undergo imaging tests like PET/CT scans, tumor biopsies, and complete questionnaires to assess responses. Researchers monitor safety through adverse event reports and measure outcomes such as objective response rates, progression-free survival, overall survival, and prostate-specific antigen (PSA) declines. Follow-up visits occur every 3 months for up to 5 years after the last treatment to track long-term effects.

Researchers are evaluating the use of 18F-PSMA-1007 PET/CT imaging in adult men with prostate cancer, particularly those with a history of radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy, or who have high-risk features for metastatic disease. This phase III study aims to assess the safety of the 18F-PSMA-1007 tracer and to analyze non-specific bone lesions detected during imaging. Participants include men aged 18 and older with specific PSA levels or clinical features related to prostate cancer. Participants will receive a single intravenous injection of 18F-PSMA-1007 at a dose of 4 MBq/kg (up to a maximum of 400 MBq). The study involves imaging with PET/CT following tracer injection to observe the distribution and activity of the tracer. The safety of the tracer will be monitored immediately after injection, after the scan (approximately 2.5 hours later), and for delayed adverse events up to 7 days post-injection. Researchers will also follow non-specific bone lesions identified during the scan for at least one year to determine their nature. During the study, participants will be screened for adverse effects at multiple time points, including immediately post-injection and post-scan. They will receive information to self-report any delayed side effects occurring within one week after injection. The study will record and evaluate up to five non-specific bone lesions per participant, tracking their size and location. Safety assessments continue for up to a year after the scan to better understand the clinical relevance of these lesions. Participation duration varies depending on follow-up assessments.

Prostate cancer patients with favorable-risk disease are commonly treated with lengthy courses of image guided radiation therapy (IGRT). Researchers are investigating a shorter, more convenient approach by combining one stereotactic ablative body radiotherapy (SABR) treatment with one high-dose rate (HDR) brachytherapy treatment guided by MRI. This study aims to assess if this combined approach can maintain good cancer control while reducing side effects, treatment time, and costs. Participants will first undergo imaging and marker placement to prepare for treatment. Then they receive one SABR treatment delivering a high dose to the prostate and seminal vesicles. About one week later, imaging is repeated to plan a single HDR brachytherapy dose targeted to the prostate and visible tumor areas. Both treatments use imaging guidance to accurately deliver radiation. Dosimetric data will be collected during treatment. Patients will be monitored closely from the start of SABR treatment through five years. Assessments include evaluations of urinary, rectal, and sexual function, side effects at multiple time points, blood tests for PSA and testosterone, and quality of life questionnaires. Samples of urine, blood, and biopsy tissue will be collected before and after treatment for further study. This thorough follow-up aims to track safety, side effects, quality of life, and cancer control over time.

Researchers are studying the potential effects of 4-aminopyridine (4-AP) on recovery after peripheral nerve injuries caused by traction or crush. The study focuses on men with prostate cancer undergoing robot-assisted radical prostatectomy, as nerve injury during this surgery may lead to erectile dysfunction and urinary continence issues. This research aims to test whether 4-AP can speed up the often slow and unpredictable recovery process after such nerve injuries. Participants will receive either FDA-approved 10 mg 4-aminopyridine tablets or placebo tablets after surgery. The medication is taken orally, with a maximum of two tablets per 24 hours, and must be swallowed whole without breaking or crushing. The treatment period lasts for 60 days following surgery. The placebo is designed to look like the active drug, and participants will be reminded not to take other aminopyridine medications during the study. Throughout the study, participants will be monitored for changes in urinary incontinence and erectile function using standardized questionnaires every seven days for six months. They will also keep a daily drug diary for 90 days and complete sexual activity questionnaires regularly. The study includes follow-up for up to one year to assess recovery progress and safety. The total participation time involves regular assessments and monitoring after the surgery.

Researchers are evaluating the use of a radiotracer called 64Cu-GRIP B with PET imaging to detect granzyme B, a biomarker produced by immune cells during immunotherapy, in patients with advanced cancers that have spread to nearby tissues or lymph nodes. This phase I/II study focuses on genitourinary cancers, including renal cell carcinoma, urothelial cancer, and metastatic castration-resistant prostate cancer, aiming to assess safety and usefulness of the imaging in monitoring immune response. Participants are divided into four groups based on cancer type: metastatic genitourinary malignancies, renal cell and urothelial carcinoma, metastatic castration-resistant prostate cancer, and other solid tumors. All receive the 64Cu-GRIP B injection followed by PET scans at baseline. Some groups have additional scans at 8 weeks and at disease progression. Imaging methods include PET/CT or PET/MRI, with safety monitoring conducted at multiple time points after tracer injection. During the study, patients undergo scans, blood sampling, and tumor biopsies when applicable. Researchers monitor adverse events, tracer distribution, and tumor uptake patterns over time. Outcomes measured include safety, tracer pharmacokinetics, changes in tumor uptake values, and correlations with clinical outcomes such as response to immunotherapy and progression-free survival. Participants are followed for up to two years to assess long-term effects and disease progression.

Prostate cancer is a common cancer among men with high mortality rates. Detecting prostate tumors and metastases accurately is important but challenging with certain imaging methods like 18F-FDG PET/CT. This research evaluates a new imaging agent called 68Ga-P16-093, which targets prostate-specific membrane antigen (PSMA) and aims to compare its diagnostic ability with the well-studied 68Ga-PSMA-11 in the same group of patients with primary prostate cancer. Participants receive two whole-body PET/CT scans on consecutive days. Each scan involves an intravenous injection of either 68Ga-P16-093 or 68Ga-PSMA-11 at a dose of 1.8-2.2 MBq per kilogram of body weight. These radiopharmaceuticals are used to image prostate cancer lesions by targeting PSMA, which is overexpressed on prostate cancer cells. The study is a pilot comparison designed to assess and compare the performance of these two tracers. During the study, researchers measure the tumor detection rate and standardized uptake value (SUV) of tumors for up to one year. Participants undergo imaging procedures and provide informed consent before enrollment. The study monitors diagnostic accuracy and tracer uptake to evaluate the potential of the new agent. The total involvement includes PET/CT scans on two separate days and follow-up assessments to review the imaging results.

Researchers are studying a new imaging agent called 68Ga-PSFA, which targets two receptors, PSMA and FAP, to improve the diagnosis of diseases that express these markers. This early phase 1 trial aims to evaluate the safety, distribution in the body, and diagnostic potential of this PET radiotracer for detecting lesions in patients with PSMA or FAP positive diseases. Participants will receive a single intravenous injection of 68Ga-PSFA. This administration is designed to allow imaging of disease sites expressing the PSMA or FAP markers. No placebo or comparison group is involved, and the study focuses on one treatment arm where all patients receive the investigational imaging agent. During the study, participants will be monitored for diagnostic effectiveness within 15 days after injection. Researchers will assess how well the agent detects lesions and track any side effects or safety concerns. The trial is open to adults aged 18 and older who meet certain disease criteria and consent to participate, with no maximum age limit specified.

Researchers are investigating whether Ga-68 PSMA PET/MRI can improve the diagnosis of prostate cancer compared to multiparametric MRI (mpMRI) in men aged 40 to 85 who have not had a prostate biopsy but show signs suspicious for prostate cancer. This observational study aims to determine if PSMA PET/MRI offers better positive and negative predictive values and how lesion location agreement between PET and MRI affects diagnostic accuracy. Participants will have a Ga-68 PSMA PET/MRI scan and then be monitored for two years to see if prostate cancer is diagnosed. During this period, they will visit the clinic every six months for checkups and blood tests. The study evaluates imaging results alongside clinical outcomes to assess diagnostic performance. Throughout the study, participants will undergo regular clinical assessments including blood tests every six months for two years. Researchers will measure how well the imaging techniques predict cancer presence using positive and negative predictive values based on lesion findings and PI-RADS scores. The follow-up visits and imaging aim to monitor participants’ health and gather data on prostate cancer diagnosis over time.

Researchers are evaluating the effectiveness of 68Ga-PSMA-11 PET/CT or PET/MRI imaging in detecting biochemical recurrence of prostate cancer in Chinese male patients who have elevated PSA levels after radical prostatectomy or radiotherapy. This Phase 3, prospective, open-label, single-arm, multicenter study focuses on patients with confirmed prostate adenocarcinoma experiencing biochemical recurrence. The study seeks to understand how well the imaging tracer 68Ga-PSMA-11, also known as Illuccix®, works in this population. Participants will receive a single intravenous dose of 68Ga-PSMA-11, ranging from 111 to 259 MBq, administered over 3 to 5 minutes. After 50 to 100 minutes post-injection, they will undergo PET/CT or PET/MRI scanning from mid-thigh to the skull while lying on their back with their arms overhead. This imaging procedure is designed to detect recurrent tumor sites. During the study, participants will be monitored for up to 12 months to assess the positive predictive value of 68Ga-PSMA-11 imaging based on biopsy, clinical follow-up, and conventional imaging. Adverse events and changes in clinical management will be tracked for 3 days post-imaging. Participants must comply with scheduled visits and assessments, including PSA measurements and safety evaluations, throughout the study.