Phase II Study of ENZAlutamide Combined With Hypofractionated Radiation Therapy (ENZART) for Localized Intermediate Risk Prostate Cancer

Altres ajuts: Astellas.Background: Intermediate-risk prostate cancer (PCa) is usually treated by a combination of external beam radiation therapy (EBRT) and a short course of androgen deprivation therapy (ADT). ADT is associated with multiple side effects, including weight gain, loss of libido, and hot flashes. In contrast, anti-androgen monotherapy is generally better tolerated in spite of higher rates of gynecomastia. Objective: This study assessed the effectiveness of enzalutamide monotherapy combined with hypofractionated EBRT (Hypo-EBRT) for treating intermediate risk prostate cancer. Method: This trial was a multicenter, open-label phase II study of 6 months of enzalutamide monotherapy combined with Hypo-EBRT for intermediate-risk prostate cancer. Hypo-EBRT was initiated 8-12 weeks after initiating enzalutamide. The primary endpoint was PSA decline >80% measured at the 25th week of enzalutamide administration. Secondary end-points included assessment of toxicity, changes in anthropomorphic body measurements, sexual hormones, and metabolic changes. Results: Sixty-two patients were included in the study from January 2018 to February 2020. A PSA decline of >80% was observed in all evaluable patients at the end of enzalutamide treatment and 92% achieved PSA values under 0.1 ngr/ml. All patients remain in PSA response (<80% reduction of the initial values) 6 months after the end of enzalutamide treatment. The most frequent adverse events were hypertension, asthenia, and gynecomastia. There were no significant changes in bone density, body mass index (BMI), or patient-reported outcomes (PROs). Conclusion: Enzalutamide monotherapy is very effective along with hEBRT in reducing PSA levels for patients with intermediate-risk prostate cancer. Longer follow-up is needed to confirm the potential use of this combination in future randomized trials

Detection of risk factors that influence weight loss in patients undergoing radiotherapy

AbstractAimTo identify risk factors that influence weight loss in patients receiving radiotherapy.BackgroundIt is a well-known fact that cancer patients can be affected by malnutrition at the onset of the disease and during treatment due to the toxicity. Pretreatment weight loss alone does not predict those who will need nutritional supplementation. Instead, a variety of nutritional and tumor related factors needs to be taken into account.Material and methodsA retrospective study was conducted on 129 patients with different tumor locations. Weight loss was evaluated during radiotherapy and one month after treatment. The impact of age, ECOG, chemotherapy, pretreatment weight loss, tumor location, previous surgery and TNM were analyzed. We aimed to identify a high-risk group of patients before starting treatment.ResultsThe average net weight loss during radiotherapy and one month after treatment for this group of patients was 0.68kg and 1.6kg, respectively. Median weight loss during radiotherapy was 2.6 kg for head and neck (HN) patients and 0.27 kg for other tumor sites (p=0.028). Median weight loss one month after radiotherapy was 3.7kg for HN patients and 1.1kg for the rest of the patients (p=0.034). The median weight loss one month after treatment was 3.2 kg for patients receiving chemotherapy and 0.5kg for those patients who did not receive chemotherapy (p<0.001). A regression analysis determined that HN tumor location and the use of chemotherapy were independent risk factors.ConclusionsNutritional status must be monitored and managed before, during and after treatment. A variety of nutritional and tumor-related factors must be considered. According to our results, head and neck tumors and the use of chemotherapy are the only two factors considered statistically significant. Because patients continue to lose weight after treatment, we recommend close surveillance after radiotherapy

Multiparametric MRI for prostate cancer: a national survey of patterns of practice among radiation oncologists in Spain

Purpose: To investigate patterns of practice among Spanish radiation oncologists in the use of multiparametric magnetic resonance imaging (mpMRI) for the treatment of prostate cancer (PCa). We evaluated (1) access to mpMRI, (2) current clinical practices, and (3) physician expectations of mpMRI. Methods: Cross-sectional survey of 118 radiation oncologists at 75 Radiation Oncology (RO) departments in Spain. Results: A total of 55 radiation oncologists from 52 RO departments (52/75; 69%) completed the survey. Prostate mpMRI is performed at 94.5% of the centres that provided data. The most common indications for mpMRI in routine clinical practice were: (1) detection/localization of the tumour prior to second biopsy (82.7%), (2) cancer staging (80.8%), and (3) detection of recurrence after definitive treatment (80.8%). Most respondents (72.7%) reported modifying the primary radiotherapy treatment when mpMRI findings indicate a more advanced T stage with a resultant change in the risk group. Most respondents (90.5%) treat macroscopic local recurrence after prostatectomy with high doses, ranging from 71 to 83 Gy; in 37.7% of cases, the full dose is delivered to the entire prostate bed. In pelvic nodal recurrence, more than half (59.3%) of the respondents reported performing elective pelvic radiotherapy, including the prostate bed, with a boost to the involved nodes. Conclusions: This survey shows that prostate mpMRI is routinely used by radiation oncologists in Spain in a wide range of clinical scenarios. The findings reported here underscore the need to standardize treatment protocols for definitive and salvage radiotherapy in patients evaluated with mpMRI.Sin financiación2.441 JCR (2018) Q3, 154/230 Oncology0.883 SJR (2018) Q1, 692/2844 Clinical and Translational OncologyNo data IDR 2018UE

Adjuvant versus early salvage radiotherapy for prostate cancer patients: Time to move on

In the management of prostate cancer , few treatments have caused as much controversy as adjuvant radiotherapy (ART) after radical prostatectomy in high-risk patients In the present article, we assess the exclusion and inclusion criteria of the 6 randomised trials and 5-year biochemical relapse-free survival and overall survival rates in order to identify the patient subgroups most likely to benefit from ART. We also evaluate treatment-related toxicity and the indications for androgen deprivation therapy . The main aim of this analysis was to determine whether the available evidence, which previously appeared to support ART, now favours early salvage radiotherapy. If so, perhaps we can finally resolve the controversy surrounding the optimal timing of postoperative radiotherapy.Sin financiación3.498 JCR (2020) Q2, 36/89 Urology & Nephrology0.818 SJR (2021) Q1, 19/108 UrologyNo data IDR 2020UE

Nonmetastatic castration-resistant prostate cancer: Novel agents to treat a lethal disease

Nonmetastatic castration-resistant prostate cancer (nmCRPC) - defined as prostate-specific antigen (PSA) > 2 ng/mL, testosterone castration levels < 1.7 nm/L, and the absence of metastatic lesions on conventional imaging (computed tomography or bone scan) - has been defined as a lethal disease by the Prostate Cancer Work Group. One-third of patients with prostate cancer who receive androgen deprivation therapy for biochemical recurrence after local treatment will develop CRPC, with death occurring an average of 2.5 years after diagnosis of castration resistance. Most patients diagnosed with nmCRPC are asymptomatic or minimally symptomatic at diagnosis due to local treatment. In patients with short PSA doubling times (< 10 mo) and high baseline PSA levels, there is a high risk of bone metastases followed by prostate cancer-related mortality. These patients also present significant morbidity that negatively impacts quality of life (QoL). Recently, the results of three randomized trials (PROSPER, SPARTAN, and ARAMIS) were published. Those trials evaluated the efficacy of three different androgen receptor inhibitors - enzalutamide, apalutamide, and darolutamide - in patients with nmCRPC. In all three trials, the study drugs improved both metastasis-free survival and overall survival compared to placebo, plus on-going androgen deprivation therapy without a negative impact on QoL. In patients with nmCRPC, the most important clinical objective is early detection and treatment to maintain a low tumor burden and to prolong the symptom-free interval. For patients with nmCRPC, these novel drugs offer new hope for better QoL and survival outcomes.Sin financiaciónNo data 2021UE

Uroncor consensus statement: Management of biochemical recurrence after radical radiotherapy for prostate cancer: From biochemical failure to castration resistance

Management of patients who experience biochemical failure after radical radiotherapy with or without hormonal therapy is highly challenging. The clinician must not only choose the type of treatment, but also the timing and optimal sequence of treatment administration. When biochemical failure occurs, numerous treatment scenarios are possible, thus making it more difficult to select the optimal approach. Moreover, rapid and ongoing advances in treatment options require that physicians make decisions that could impact both survival and quality of life.The aim of the present consensus statement, developed by the Urological Tumour Working Group (URONCOR) of the Spanish Society of Radiation Oncology (SEOR), is to provide cancer specialists with the latest, evidence-based information needed to make the best decisions for the patient under all possible treatment scenarios.The structure of this consensus statement follows the typical development of disease progression after biochemical failure, with the most appropriate treatment recommendations given for each stage. The consensus statement is organized into three separate chapters, as follows: biochemical failure with or without local recurrence and/or metastasis; progression after salvage therapy; and treatment of castration-resistant patients

PET/TC con 68Ga-PSMA, importancia en la práctica hospitalaria. Visión del oncólogo radioterápico

Radiotherapy is a treatment with curative intent, both in patients with primary diagnosis of prostate cancer (PCa) and in patients presenting with biochemical recurrence after radical prostatectomy (RP). Moreover, the use of stereotactic body radiotherapy as a metastasis directed therapy in patients with oligometastatic PCa has significantly increased in the recent years. Conventional imaging techniques, including transrectal ultrasound, computed tomography (CT), morphologic magnetic resonance and bone scintigraphy have traditionally played a minor role in all those clinical scenarios due to its low diagnostic accuracy. The recent development of the positron emission tomography (PET) radiotracer 68Ga-PSMA binding to the prostate specific membrane antigen (PSMA), a transmembrane glycoprotein overexpressed in PCa cells, has shown promising results. Detection rates for PCa lesions are higher than CT and higher than the best technique available, the PET/CT with choline. Its superiority has been demonstrated even at very low PSA levels (<1 ng/ml). This increase in diagnostic accuracy represents a potential impact on patient management, especially in radiotherapy. Even if this imaging technique is already available for routine clinical practice in some European countries, in Spain, unfortunately, there is very limited access. In this review, we analyze the main studies that investigate the usefulness of 68Ga-PSMA PET/CT in patients with PCa and its potential impact on radiotherapy treatments. In addition, we compared the 68Ga-PSMA PET/CT, with the multiparametric magnetic resonance imaging and the PET/CT with choline, in the different clinical scenarios.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

PET/TC con 68Ga-PSMA, importancia en la práctica hospitalaria. Visión del oncólogo radioterápico

Radiotherapy is a treatment with curative intent, both in patients with primary diagnosis of prostate cancer (PCa) and in patients presenting with biochemical recurrence after radical prostatectomy (RP). Moreover, the use of stereotactic body radiotherapy as a metastasis directed therapy in patients with oligometastatic PCa has significantly increased in the recent years. Conventional imaging techniques, including transrectal ultrasound, computed tomography (CT), morphologic magnetic resonance and bone scintigraphy have traditionally played a minor role in all those clinical scenarios due to its low diagnostic accuracy. The recent development of the positron emission tomography (PET) radiotracer 68Ga-PSMA binding to the prostate specific membrane antigen (PSMA), a transmembrane glycoprotein overexpressed in PCa cells, has shown promising results. Detection rates for PCa lesions are higher than CT and higher than the best technique available, the PET/CT with choline. Its superiority has been demonstrated even at very low PSA levels (<1 ng/ml). This increase in diagnostic accuracy represents a potential impact on patient management, especially in radiotherapy. Even if this imaging technique is already available for routine clinical practice in some European countries, in Spain, unfortunately, there is very limited access. In this review, we analyze the main studies that investigate the usefulness of 68Ga-PSMA PET/CT in patients with PCa and its potential impact on radiotherapy treatments. In addition, we compared the 68Ga-PSMA PET/CT, with the multiparametric magnetic resonance imaging and the PET/CT with choline, in the different clinical scenarios.La radioterapia es un tratamiento curativo indicado en pacientes con cáncer de próstata (CaP) primario y en aquellos con recurrencia bioquímica tras prostatectomía radical (PR). Además, recientemente, ha habido un aumento en el uso de técnicas de alta precisión como la radioterapia estereotáctica fraccionada corporal para tratar un número limitado de metástasis en pacientes con CaP oligometastásico. Las pruebas de imagen convencional (ecografía transrectal, tomografía computarizada [TC], resonancia magnética morfológica y gammagrafía ósea) tienen un papel menor en estos escenarios, debido a su bajo rendimiento diagnóstico. Recientemente, se ha desarrollado el radiotrazador 68Ga-PSMA, para la tomografía por emisión de positrones (PET), que es un ligando del antígeno de membrana específico de próstata (PSMA), una proteína transmembrana sobrexpresada en las células del CaP. Sus resultados son prometedores, con tasas de detección de lesiones tumorales mayores que la TC y mayor que la mejor técnica disponible actualmente, la PET con colina. Su superioridad es más evidente en pacientes con valores bajos de PSA (< 1 ng/ml). Esta mejora en el rendimiento diagnóstico representa un potencial impacto en el manejo terapéutico, especialmente en radioterapia. A pesar de que la prueba ya está disponible en la práctica clínica diaria de otros países europeos, en España su uso es muy limitado. En esta revisión, analizamos los principales estudios que investigan la utilidad de la PET/TC con 68Ga-PSMA en pacientes con CaP y su potencial impacto en los tratamientos de radioterapia. Además, comparamos la PET/TC con PSMA, con la resonancia magnética multiparamétrica y la PET/TC con colina, en los distintos escenarios clínicos.Sin financiaciónNo data JCR 20180.235 SJR (2018) Q3, 236/341 Radiology, Nuclear Medicine and ImagingNo data IDR 2018UE