Undergraduate Training in the Epidemiology of Prostate Cancer with Focus on Genetics of Disease Progression and Quality of Life

2014 ◽  
Author(s):  
Emanuela Taioli
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Disease Progression ◽  
Undergraduate Training

Radium-223 (Ra-223) versus novel antihormone therapy (NAH) for progressive metastatic castration-resistant prostate cancer (mCRPC) after 1 line of NAH: RADIANT, an international phase 4, randomized, open-label study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS5093-TPS5093
Author(s):  
Karim Fizazi ◽  
Aránzazu González del Alba ◽  
Özgüroğlu Mustafa ◽  
Iwona Anna Skoneczna ◽  
Heiko Krissel ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Adverse Events ◽  
Bone Metastases ◽  
Disease Progression ◽  
Group Performance ◽  
Short Form ◽  
Cross Resistance ◽  
Hormone Sensitive

TPS5093 Background: Men with mCRPC often receive sequential NAH (abiraterone and enzalutamide) despite reported cross-resistance, indicating a need for further life-prolonging options for progressive disease after prior NAH. Ra-223 is a targeted alpha therapy approved for mCRPC with symptomatic bone metastases based on the phase 3 ALSYMPCA study, in which it demonstrated significantly increased overall survival (OS), reduced symptomatic skeletal event (SSE) risk, improved quality of life, and reduced treatment-emergent adverse event rates vs placebo. As life-prolonging therapy is increasingly used in hormone-sensitive settings, this study has been designed to assess Ra-223 outcomes in patients with mCRPC that progressed after prior treatment with NAH and docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC) or mCRPC. Methods: This study is conducted in accordance with the Declaration of Helsinki, international ethical and good clinical practice guidelines, and local laws and regulations, with institutional review board/ethics committee approval at each site and written informed consent from patients before participation. This trial is registered with EudraCT: 2019-000476-42. Participants must be ≥18 years old, with an Eastern Cooperative Oncology Group performance status of 0/1; they must have mCRPC that progressed on/after ≥3 months of NAH for mHSPC or mCRPC and ≥2 cycles of docetaxel unless they refused or were ineligible, with ≥2 bone metastases on bone scan, no visceral metastases, and a worst pain score ≥1 on the Brief Pain Inventory-Short Form. Patients are randomized 1:1 to Ra-223 or NAH: Ra-223 55 kBq/kg intravenously every 4 weeks for 6 cycles or until disease progression, death, or withdrawal of consent if earlier; or abiraterone 1000 mg + prednisone 10 mg daily (if prior enzalutamide) or enzalutamide 160 mg daily (if prior abiraterone) until disease progression, death, or withdrawal of consent. NAH dosing may be modified to manage adverse events. Patients must use luteinizing hormone-releasing hormone analogs, if not surgically castrated, and bone health agents (bisphosphonates or denosumab) throughout the study. The primary endpoint is OS. Secondary endpoints are time to first SSE, radiologic progression-free survival, time to pain progression, adverse events, fracture incidence, and time to deterioration in quality of life (FACT-P total score). Using a test with a two-sided alpha of 0.05, 90% power, and randomization ratio of 1:1, approximately 508 events are required to detect a 33% increase in OS with Ra-223 vs NAH, assuming a median OS of 10 months with NAH. The expected study duration is 55 months, with a target of 696 patients to be randomized. The first patient was enrolled on November 9, 2020; 5 patients have been randomized and 2 have started treatment to date. Clinical trial information: 2019-000476-42.

Quality of life and fear of disease progression are associated with aspects of health literacy in men with prostate cancer from Germany

2019 ◽  
Vol 28 (5) ◽  
pp. 2283-2292 ◽  
Author(s):  
Marius Haack ◽  
Silke Kramer ◽  
Gabriele Seidel ◽  
Marie-Luise Dierks
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Health Literacy ◽  
Disease Progression

Suramin Therapy for Patients With Symptomatic Hormone-Refractory Prostate Cancer: Results of a Randomized Phase III Trial Comparing Suramin Plus Hydrocortisone to Placebo Plus Hydrocortisone

2000 ◽  
Vol 18 (7) ◽  
pp. 1440-1450 ◽  
Author(s):  
Eric J. Small ◽  
Mark Meyer ◽  
M. Ernest Marshall ◽  
Leonard M. Reyno ◽  
Frederick J. Meyers ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Disease Progression ◽  
Opioid Analgesic ◽  
Performance Status ◽  
Phase Iii ◽  
Moderate Intensity ◽  
Hormone Refractory Prostate Cancer ◽  
Hormone Refractory

PURPOSE: Suramin is a novel agent that has demonstrated preliminary evidence of antitumor activity in hormone-refractory prostate cancer (HRPC). A prospective randomized clinical trial was designed to evaluate pain and opioid analgesic intake as surrogates for antitumor response in HRPC patients with significant, opioid analgesic–dependent pain. PATIENTS AND METHODS: A double-blind, placebo-controlled trial randomized patients to receive a 78-day, outpatient regimen of either suramin plus hydrocortisone (HC, 40 mg/d) or placebo plus HC. Treatment assignment was unblinded when either disease progression or dose-limiting toxicity occurred; placebo patients were allowed to cross-over to open-label suramin plus HC. In addition to pain and opioid analgesic intake, prostate-specific antigen (PSA) response, time to disease progression, quality of life, performance status, and survival were compared. RESULTS: Overall mean reductions in combined pain and opioid analgesic intake were greater for suramin plus HC (rank sum P = .0001). Pain response was achieved in a higher proportion of patients receiving suramin than placebo (43% v 28%; P = .001), and duration of response was longer for suramin responders (median, 240 v 69 days; P = .0027). Time to disease progression was longer (relative risk = 1.5; 95% confidence interval, 1.2 to 1.9) and the proportion of patients with a greater than 50% decline in PSA was higher (33% v 16%; P = .01) in patients who received suramin. Neither quality of life nor performance status was decreased by suramin treatment, and overall survival was similar. Most adverse events were of mild or moderate intensity and were easily managed medically. CONCLUSION: Outpatient treatment with suramin plus HC is well tolerated and provides moderate palliative benefit and delay in disease progression for patients with symptomatic HRPC.

Randomised prospective study of intermittent versus continuous androgen suppression in advanced prostate cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5015-5015 ◽  
Author(s):  
K. Miller ◽  
U. Steiner ◽  
A. Lingnau ◽  
U. Keilholz ◽  
U. Witzsch ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Disease Progression ◽  
Median Time ◽  
Advanced Prostate Cancer ◽  
Continuous Group ◽  
Intermittent Therapy ◽  
Continuous Therapy ◽  
Androgen Suppression

5015 Background: Based on results of animal experiments intermittent androgen blockade was suggested to delay progression of advanced prostate cancer to the hormone refractory stage. We conducted a prospective randomized study to compare intermittent with continuous androgen suppression. Methods: This was a multi-centre, randomised, two-arm study comparing treatment with goserelin + bicalutamide (intermittent, group A) vs. goserelin + bicalutamide (continuous, group B). The primary endpoint was time to clinical and/or biochemical progression of the disease despite androgen suppression. Secondary enpoints were survival time, patient’s quality of life (QoL) and toxicity. Patients eligibility criteria were: histologically confirmed adenocarcinoma of the prostate in clinical stage T1–4N1–3M0 or T1–4N0–3M1 (D1 oder D2). After an induction phase of 24 weeks with MAB, 335 patients whose PSA decreased under 4 ng/ml or = 90% from baseline were randomized. Results: About two-thirds of the patients of both the intermittent and the continuous therapy arm (65% versus 66%, ITT population) experienced a clinical and/or biochemical disease progression due to any reason during this study. The median time to disease progression was longer for patients randomised to the intermittent therapy arm (16.6 months) compared with patients randomised to the continuous therapy arm (11.5 months). This difference however was not statistically significant (log rank test, p=0.1758). The median time to death from any cause was 51.4 month in the intermittent arm compared and 53.8 months in the continuous therapy arm (p = 0.658). There were no differences in the incidence of patients with AEs or SAEs or in any other safety parameter between patients treated intermittently and patients treated continuously. Patients’ self-assessment of their overall health and of their sexual activity appeared to be favourable in the intermittent compared with the continuous therapy arm. 88% of all patients treated intermittently experienced more than 50% of the number of treatment days as treatment-free days. Conclusions: Intermittent therapy in D1 and D2 prostate cancer patients appears to be safe and feasible. Off treatment periods are > 40 % and attribute to patients quality of life. No significant financial relationships to disclose.

386: Health Related Quality of Life in Low-Income, Uninsured Men with Prostate Cancer

2004 ◽  
Vol 171 (4S) ◽  
pp. 101-102
Author(s):  
Tracey L. Krupski ◽  
Arlene Fink ◽  
Lorna Kwan ◽  
Sarah Connor ◽  
Sally L. Maliski ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Low Income ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

158: The Impact of Skeletal-Related Events on Preferences and Health-Related Quality of Life of Patients with Metastatic Prostate Cancer

2004 ◽  
Vol 171 (4S) ◽  
pp. 42-42 ◽  
Author(s):  
Kevin P. Weinfurt ◽  
Liana D. Castel ◽  
Yun Li ◽  
Fred Saad ◽  
Justin W. Timbie ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Metastatic Prostate Cancer ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Skeletal Related Events ◽  
The Impact
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