Prostate Cancer

Researchers are evaluating a combination treatment for men with prostate cancer that has spread to other parts of the body and continued to grow despite treatments that lower male hormones. This phase I trial compares the effects of a radioactive drug called lutetium Lu 177 (177^Lu)-PSMA-617 alone and combined with a vaccine therapy called Sipuleucel-T. The goal is to see if the combination can better stimulate the immune system and control the cancer. Participants are randomly assigned to one of two groups. One group receives 177^Lu-PSMA-617 intravenously every 6 weeks for up to 6 cycles, while the other group receives the same radioactive drug plus Sipuleucel-T starting at week 8, given every 2 weeks for up to 3 doses. Both groups undergo various imaging scans such as PET/CT, bone scans, MRI, and blood tests to monitor response and safety throughout the study. During the trial, patients have blood samples taken and may undergo leukapheresis (removal of certain blood cells for vaccine preparation). They are followed closely with scans and clinical visits during treatment and after completion. Follow-up visits occur at 30 days, then every 3 months for up to a year, and every 6 months until disease progression. Researchers measure immune response, safety, tumor response, progression-free survival, and overall survival over up to 3 years of observation.

Researchers are evaluating 177Lu-BetaBart, a 177Lu-labeled anti-B7-H3 monoclonal antibody, in patients with various relapsed or refractory solid tumors that are locally advanced, inoperable, or metastatic. This Phase 1/2a study aims to understand the safety, tolerability, how the drug moves through and affects the body, and early signs of anti-tumor activity. Eligible participants include adults 18 and older with cancers such as castration-resistant prostate cancer, colorectal cancer, lung cancers, head and neck cancer, ovarian, cervical, endometrial, triple negative breast cancer, and esophageal squamous cell carcinoma who have shown disease progression after recent treatments. The study has two main parts: a Phase 1 dose escalation phase to find the maximum tolerated or recommended dose using a Bayesian design, and a Phase 2a dose expansion phase at that recommended dose to confirm safety and observe preliminary anti-tumor effects. Participants receive 177Lu-BetaBart through intravenous infusions every six weeks. Each phase includes a screening period, treatment and imaging period, and a safety and long-term follow-up period to closely monitor outcomes and side effects. During the study, participants undergo assessments including imaging for disease evaluation, laboratory tests for organ function and drug effects, and monitoring of side effects for up to 30 weeks. Key outcomes include determining the suitable dose for future studies, tracking adverse events, and measuring anti-tumor activity through objective response rates and biochemical responses in prostate cancer. Pharmacokinetics, radiation dosimetry, and biokinetics of the drug are also measured at specified time points. Safety and tolerability are evaluated continuously, with follow-up to monitor long-term effects and overall health.

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 studying men with localized prostate cancer to see if a special imaging agent called 18F-DCFPyL can help detect how well standard treatments work. The study focuses on men 18 years and older who are newly diagnosed and plan to receive stereotactic body radiation therapy (SBRT), with or without hormone therapy called androgen deprivation therapy (ADT). The goal is to better identify treatment response early and improve monitoring of prostate cancer. Participants will receive SBRT treatment and may also get ADT depending on their plan. They will undergo several imaging scans including MRI and PET/CT using the 18F-DCFPyL radiotracer at different times: before treatment, 8 weeks after starting ADT (if applicable), 6 months after completing SBRT, and at any recurrence. The imaging helps researchers observe how the cancer responds to treatment. The study is designed to include up to 100 participants divided into groups based on their treatment plans. During the study, participants will have medical history reviews, physical exams, and blood and urine tests. They will provide samples from prior biopsies and complete quality of life questionnaires. Follow-up visits will occur one month after treatment, then every three months for a year, and every six months for an additional year, allowing researchers to track imaging results and health outcomes over time. This long-term monitoring aims to better understand prostate cancer treatment response and patient well-being.

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) to understand how different PET/CT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PET/CT scans at different times: before starting LuPSMA radioligand therapy (RLT), and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PET/CT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

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 evaluating a new radiation treatment for localized prostate cancer using a single high-dose stereotactic body radiotherapy (SBRT) session. This trial focuses on delivering 24 Gy in one fraction with a technique that spares the urethra, aiming to reduce side effects while treating the prostate and seminal vesicles. The study is prospective, non-randomized, and conducted at a single center with the goal of assessing safety, toxicity, cancer control, survival, and quality of life over time. The treatment involves implanting fiducials, performing simulation CT and MRI scans, and delivering a single high-dose radiation session similar to high-dose-rate brachytherapy but sparing the urethra. Patients with negative lymph nodes and no distant metastases will receive the radiation dose of 24 Gy in one day. Androgen deprivation therapy (ADT) will be used for some patients based on risk. Short-term cortisone and alpha-blockers will be given to prevent side effects. The study will enroll up to 70 patients in phases, monitoring toxicity closely before continuing enrollment. Participants will have follow-up visits at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months. These visits include blood tests for prostate-specific antigen (PSA) and testosterone, imaging as needed, and quality of life questionnaires covering general health, urinary symptoms, sexual function, and prostate cancer-specific issues. The main outcome is measuring acute toxicity one month after treatment, with longer-term monitoring of cancer control, survival, toxicity, and quality of life through five years.

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.