Saint Doulchard

Researchers are studying prostate cancer patients undergoing radical prostatectomy to compare three surgical methods robot-assisted laparoscopy, conventional laparoscopy, and laparotomy. The study aims to evaluate the impact of these techniques on urinary and erectile functions, as well as their cost-effectiveness and long-term outcomes. This large, multicenter prospective observational study responds to previous concerns about the lack of high-quality evidence for robot-assisted surgery in prostate cancer treatment. Participants will undergo one of the three prostatectomy procedures robot-assisted laparoscopy, conventional laparoscopy, or laparotomy. Urinary and erectile functions will be assessed before and after surgery using standardized scores like the EPIC 50 and the International Index of Erectile Function IIEF-5. Outcomes including urinary incontinence, erectile dysfunction, and prostate-specific antigen PSA levels will be followed for up to five years. Cost-effectiveness will be evaluated at 12 months using the EQ5d-5L score. Throughout the study, participants will be evaluated at multiple time points, including 45 days and up to five years after surgery, to monitor urinary and erectile functions and other prostatectomy-related effects. Assessments involve questionnaires and clinical measurements. This comprehensive follow-up is designed to help determine the benefits and risks of each surgical approach, supporting informed decisions for patients and healthcare authorities. The study excludes patients without French health insurance or those unable to consent, focusing on adult males scheduled for prostatectomy.

The TEMPOS-GEniToUrinary Group GETUG study is a multicenter, medico-economic trial comparing two radiation treatmentsbrachytherapy and stereotactic body radiotherapy SBRTin men with low and intermediate risk prostate cancer. The study particularly focuses on erectile dysfunction as a key outcome. Researchers aim to evaluate the cost-utility of SBRT compared to standard Iodine 125 brachytherapy over a period of three years after treatment, including secondary analyses on cost-effectiveness and quality of life up to five years. Participants are assigned to one of two treatment groups. The experimental group receives SBRT delivering 7.25 Gy per fraction, given in five doses for a total of 36.25 Gy to the prostate. Fiducials are implanted in the prostate to help guide treatment using Cyberknife or a conventional linear accelerator with tracking systems. The control group receives brachytherapy with Iodine 125, delivering a total dose of 144 Gy to the prostate. The study includes long-term follow-up to assess erectile dysfunction, genito-urinary and gastro-intestinal toxicities, and quality of life up to five years after treatment. Participants will undergo monitoring and assessments throughout the study period, including evaluations of erectile dysfunction and other side effects. The main outcome measured is the incremental cost-utility ratio comparing SBRT to brachytherapy at three years, with further health economic evaluations at five years. The trial plans to recruit about 240 men across multiple centers over two years, with ongoing data collection on treatment impact, side effects, and quality of life to inform future treatment recommendations and health insurance budgeting.

Researchers are conducting a French non-interventional longitudinal multicenter cohort study to evaluate the added value of olaparib for treating patients with metastatic castration-resistant prostate cancer mCRPC in real-world settings. The study aims to assess treatment sequencing, effectiveness, safety, and BRCA testing patterns, helping to inform future clinical practice. This observational study is sponsored by AstraZeneca. The study observes adult male patients who have started olaparib treatment within at least the last two months or who participated in a funded early access program. There are no assigned treatment groups or interventions beyond olaparib use as decided by their physician. Data collection continues up to 32 months to capture treatment patterns and patient characteristics. Participants data on treatment duration, disease progression, therapy sequences, symptomatic skeletal events, and BRCA testing timing will be collected and analyzed up to 24 months from olaparib initiation. Socio-demographic and clinical characteristics of patients and physicians will be gathered at the end of enrollment. The study monitors reasons for dose changes, interruptions, and treatment cessation, ensuring comprehensive real-world evidence about olaparib in mCRPC patients.

This research aims to observe patients in France with HER2-negative early breast cancer who are treated with olaparib, a medication chosen by their doctors. The study focuses on understanding how often patients complete the full course of olaparib treatment and gathers information on related genetic factors and medical history. It is a national, multicenter, prospective observational study without experimental treatment assignment. Participants in this study receive adjuvant olaparib treatment as part of their usual care under their physicians discretion. The study does not assign treatments but follows patients who start olaparib, tracking their treatment progress for up to 18 months after inclusion. There are no additional interventions or placebo groups. Throughout the study, researchers collect data on treatment completion rates, types of BRCA mutations, variant types, medical history, and the time until olaparib treatment stops. Participation involves observational follow-up, with no extra treatment visits beyond routine care. The overall participation lasts 18 months after a patients enrollment, focusing on real-world treatment experiences and outcomes.

Researchers are investigating treatments for patients with oligometastatic brain disease, a condition where a limited number of brain metastases occur from systemic cancer. The study focuses on comparing two types of stereotactic radiotherapyhypofractionated stereotactic radiotherapy HSRT and single-dose stereotactic radiosurgery SRSto better preserve neurological function and independence. This randomized phase III trial aims to address the lack of prospective comparison between these two radiation approaches in managing brain metastases from radioresistant cancers such as renal cell carcinoma, sarcoma, and melanoma. Participants will be randomly assigned to receive either HSRT, which delivers 3 doses of 10 Gy over one week, or the historical single-dose SRS, delivering 20 to 25 Gy in one fraction. Both treatments precisely target up to five brain metastases, with lesion sizes between 10 and 25 mm, using a thermoformed mask for treatment delivery. The study also includes medico-economic evaluation and follows established guidelines for patient eligibility, including performance status and neuropsychological ability. During the study, participants will undergo regular assessments including local tumor control measured by RANO-BM criteria at 12 months post-treatment. Researchers will monitor brain toxicities and radionecrosis using standardized criteria over the same period. Participants will have blood tests and brain MRI scans with contrast agents unless contraindicated. The study involves a multidisciplinary approach and requires informed consent, with follow-up visits and evaluations planned for at least one year after treatment to assess effectiveness and safety outcomes.