scholarly journals Integrating chemohormonal therapy and surgery in known or suspected lymph node metastatic prostate cancer

2015 ◽  
Vol 18 (3) ◽  
pp. 276-280 ◽  
Author(s):  
A J Zurita ◽  
L L Pisters ◽  
X Wang ◽  
P Troncoso ◽  
P Dieringer ◽  
...  
BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e042953
Author(s):  
Martin John Connor ◽  
Taimur Tariq Shah ◽  
Katarzyna Smigielska ◽  
Emily Day ◽  
Johanna Sukumar ◽  
...  

IntroductionSurvival in men diagnosed with de novo synchronous metastatic prostate cancer has increased following the use of upfront systemic treatment, using chemotherapy and other novel androgen receptor targeted agents, in addition to standard androgen deprivation therapy (ADT). Local cytoreductive and metastasis-directed interventions are hypothesised to confer additional survival benefit. In this setting, IP2-ATLANTA will explore progression-free survival (PFS) outcomes with the addition of sequential multimodal local and metastasis-directed treatments compared with standard care alone.MethodsA phase II, prospective, multicentre, three-arm randomised controlled trial incorporating an embedded feasibility pilot. All men with new histologically diagnosed, hormone-sensitive, metastatic prostate cancer, within 4 months of commencing ADT and of performance status 0 to 2 are eligible. Patients will be randomised to Control (standard of care (SOC)) OR Intervention 1 (minimally invasive ablative therapy to prostate±pelvic lymph node dissection (PLND)) OR Intervention 2 (cytoreductive radical prostatectomy±PLND OR prostate radiotherapy±pelvic lymph node radiotherapy (PLNRT)). Metastatic burden will be prespecified using the Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease (CHAARTED) definition. Men with low burden disease in intervention arms are eligible for metastasis-directed therapy, in the form of stereotactic ablative body radiotherapy (SABR) or surgery. Standard systemic therapy will be administered in all arms with ADT±upfront systemic chemotherapy or androgen receptor agents. Patients will be followed-up for a minimum of 2 years. Primary outcome: PFS. Secondary outcomes include predictive factors for PFS and overall survival; urinary, sexual and rectal side effects. Embedded feasibility sample size is 80, with 918 patients required in the main phase II component. Study recruitment commenced in April 2019, with planned follow-up completed by April 2024.Ethics and disseminationApproved by the Health Research Authority (HRA) Research Ethics Committee Wales-5 (19/WA0005). Study results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT03763253; ISCRTN58401737


The Prostate ◽  
2010 ◽  
Vol 70 (10) ◽  
pp. 1110-1118 ◽  
Author(s):  
David Schilling ◽  
Joerg Hennenlotter ◽  
Karl Sotlar ◽  
Ursula Kuehs ◽  
Erika Senger ◽  
...  

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 117-117
Author(s):  
Mary Mahler ◽  
Esmail Mutahar Al-Ezzi ◽  
Noa Shani Shrem ◽  
Eric Winquist ◽  
Christina M. Canil ◽  
...  

117 Background: Since docetaxel has been advanced to the metastatic castrate-sensitive prostate cancer (mCSPC) setting, there is a lack of evidence guiding its re-introduction upon castrate-resistant (CR) progression. We sought to identify clinical characteristics and outcomes of patients subjected to docetaxel rechallenge (DR) following prior docetaxel exposure in the mCSPC realm. Methods: Patients rechallenged with docetaxel following treatment in the mCSPC setting were identified from three academic centres in Ontario, Canada. Retrospective chart reviews were performed to identify clinical, treatment and outcome variables. Results: Of the 45 patients with DR initiated between 06/2015 and 07/2020, the median age was 65, 60% had a Gleason score of ≥8, and 64% had an ECOG of ≤1. 56% had bone only metastasis, 4% lymph node only metastasis, 29% bone and lymph node metastasis, and 11% had visceral metastasis. In the mCSPC setting, 98% of patients received 6 cycles of docetaxel with 13% requiring dose delays. Of 43 informative patients, all had a PSA response to chemohormonal therapy. 91% achieved at least a 50% PSA response (PSA50), of which 40% had a 50-89% PSA reduction and 51% had a ≥90% PSA reduction. 29% of patients obtained a PSA nadir of < 0.2 ng/mL. 16% had CR progression in < 6 months, 56% in 6-12 months, and 28% in > 12 months. DR was initiated after a median of 20.8 months (range 6.0-40.4) following the last dose of docetaxel for mCSPC, and was given as first line treatment for CR disease to 7%, second line to 51%, third line to 40%, and fourth line or beyond to 2% of patients. 69% of patients had received an androgen-receptor axis targeted therapy prior to DR, 18% radium 223, and 7% had received a trial drug. Notably, no patients had received cabazitaxel prior to DR. The median number of cycles of docetaxel received at rechallenge was 5 (range 1-11) with 18% of patients requiring treatment delays. 64% of patients stopped treatment due to progression, 16% due to side effects, 7% at the patient’s request, 7% due to completion of the planned number of cycles, and 6% due to death or other causes. Among 44 informative patients, 23% achieved at least a PSA50, with 18% having a 50-90% PSA reduction, and 5% having a ≥90% PSA reduction. The median time to progression (biochemical, radiographic, or death) was 2.3 months (95%CI 1.7-4.4) and the median overall survival was 11.0 months (95%CI 8.5-14.3). Conclusions: DR following exposure to docetaxel in the mCSPC setting resulted in a PSA50 in only around one quarter of patients. Both the median time to progression and overall survival were found to be short. With future investigations, we hope to identify clinical variables that will help predict which patients might benefit most from DR.


2019 ◽  
Vol 5 (3) ◽  
pp. 381-388 ◽  
Author(s):  
Marco Bandini ◽  
Felix Preisser ◽  
Sebastiano Nazzani ◽  
Michele Marchioni ◽  
Zhe Tian ◽  
...  

2020 ◽  
Vol 9 (18) ◽  
pp. 6629-6637
Author(s):  
Keisuke Tsuchida ◽  
Koji Inaba ◽  
Tairo Kashihara ◽  
Naoya Murakami ◽  
Kae Okuma ◽  
...  

2017 ◽  
Vol 35 (5_suppl) ◽  
pp. 153-153
Author(s):  
Jeffrey Hough ◽  
Tammy J. Rodvelt ◽  
Miles Thomas ◽  
Brian Ma ◽  
Michael W. Rabow ◽  
...  

153 Background: Chemohormonal therapy is standard of care for newly diagnosed metastatic prostate cancer (mPC) patients (pts) but is associated with significant adverse effects and negative metabolic changes. We performed a pilot study to investigate whether participation in a multi-disciplinary clinic to mitigate adverse effects of treatment is feasible. Methods: Pts with recently diagnosed mPC who were planning to start or had recently started chemohormonal therapy were prospectively enrolled in a multi-disciplinary clinic that included individualized monthly counseling from a physical therapist, oncology dietitian, and palliative care specialist on a rotating basis for 12 months. Patients were assessed quarterly for changes in % body fat, weight, serum levels of 25-OH vitamin D, fasting lipids/glucose/insulin, and quality of life (QOL). DXA bone density scans were performed at baseline and end of 12 months. The primary endpoint was the completion rate of scheduled visits. Results: 7 pts were enrolled between September 2015 and June 2016. All patients had extensive disease ( > 4 bone metastases and/or visceral metastases) at the time of study entry, and all 7 patients completed six cycles of docetaxel-based chemotherapy, and remained on hormone therapy for the duration of study. The percentage of completed visits was 98% (54/55 planned visits). The percentage of completed assessments including QOL questionnaires was 81%. No skeletal-related complications were observed. Median percent increase from baseline in body weight and % body fat was 3.51% and 20%, respectively. Four of the seven patients had osteopenia at baseline. Patient reported satisfaction was high and positive impact on psychosocial well-being was observed. Conclusions: Participation in a multi-disciplinary clinic by men receiving intensive chemohormonal therapy for metastatic prostate cancer was feasible. Patients are at risk for adverse metabolic and bone toxicity with therapy, underscoring the potential positive impact of a multi-disciplinary clinic. A randomized study to detect objective improvements in health outcomes is underway. Clinical trial information: NCT02168062.


Author(s):  
Barbara Alicja Jereczek-Fossa ◽  
Giancarlo Beltramo ◽  
Laura Fariselli ◽  
Cristiana Fodor ◽  
Luigi Santoro ◽  
...  

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