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.

Androgen suppression of advanced prostate cancer: intermittent or continuous therapy?

2001 ◽  
Vol 37 ◽  
pp. S218 ◽  
Author(s):  
E.M.C. Schasfoort ◽  
P. Heathcote ◽  
M.T.W.T. Lock ◽  
M. Zerbib ◽  
D.W.W. Newling
Keyword(s):  
Prostate Cancer ◽  
Advanced Prostate Cancer ◽  
Continuous Therapy ◽  
Androgen Suppression

Safety, Efficacy, and Impact on Quality of Life of Palliative Robotic Cystectomy for Advanced Prostate Cancer

2020 ◽  
Author(s):  
Raj R. Bhanvadia ◽  
Roger K. Khouri ◽  
Caleb Ashbrook ◽  
Solomon L. Woldu ◽  
Vitaly Margulis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Advanced Prostate Cancer ◽  
Robotic Cystectomy

Phase III intermittent MAB vs continuous MAB

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4513-4513 ◽  
Author(s):  
F. M. Calais Da Silva ◽  
F. Calais Da Silva ◽  
A. Bono ◽  
M. Brausi ◽  
P. Whelan ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Metastatic Prostate Cancer ◽  
Locally Advanced ◽  
Phase Iii ◽  
Induction Treatment ◽  
Intermittent Therapy ◽  
Continuous Therapy ◽  
Therapeutic Tools ◽  
Depot Injections

4513 Background: Patients with locally advanced or metastatic prostate cancer cannot be cured with any of the therapeutic tools available today. Methods: After an initial induction treatment of three months, with CPA 200 mg for two week’s and then monthly depot injections of LHRH analogue (decaptyl) plus 200 mg of CPA daily in 766 patients with locally advanced or metastatic prostate cancer, 626 patients whose PSA decreased below 4 or to 80% below their initial value, were randomised to intermittent or continuous therapy. Results: Among the 314 patients on Intermittent therapy, 50% have been off therapy for at least 52 weeks following the initial LHRH therapy, 29% have been off therapy for over 36 months. For the 197 patients whose PSA went down to ≤ 2 ng/ml, the median time off therapy was 74 weeks. When these patients returned to therapy they had a median of 14 weeks of treatment, followed by a second period off therapy, median 70 weeks. Patients with PSA < 2 ng/ml have spent a median of 82% of their time receiving no therapy.After a median follow up of 51 months, 321 patients have died: 162 in the Intermittent arm compared to 159 in the Continuous arm (HR = 1.03 [95% confidence interval 0.83, 1.28; p = 0.79]). Estimated survival at 5 years was 53.8% in the Intermittent Group and 51.0% in the Continuous Group.Subjective or Objective progression was noted in 224 patients, 113 on the intermittent arm and 111 on the continuous arm with a hazard ratio of 1.09 (95% CI 0.84, 1.42), p=0.52. The main differences in quality of life between the two arms of the study were confined to sexual function.Sexual activity was significantly greater (p<0.01) in the intermittent arm with 41% of men reporting sexual activity at 9 months, 40% at 15 months and 35% at 21 months.The most commonly reported side effects were hot flushes, were more frequently among those on Continuous Therapy, 30% of continuous patients compared to 20% of intermittent patients, p < 0.01. Conclusions: There is no evidence that Intermittent therapy leads to a significantly elevated hazard of dying (p = 0.79) or to a greater subjective or objective progression (p = 0.52) and with less impact on quality of live and less medication, patients with PSA < 2 ng/ml on randomisation have spent a median of 82% of their time receiving no therapy. We think that intermittent therapy is an option to use in regular clinic. No significant financial relationships to disclose.

Randomized phase III trial to evaluate radiopharmaceuticals and zoledronic acid in the palliation of osteoblastic metastases from lung, breast, and prostate cancer: Report of RTOG 0517.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS9150-TPS9150 ◽  
Author(s):  
Michael J. Seider ◽  
Stephanie Shook ◽  
Corey J. Langer ◽  
Gwen Wyatt ◽  
William F. Demas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Median Time ◽  
Standard Dose ◽  
Cox Proportional Hazards ◽  
Phase Iii ◽  
Relative Reduction

TPS9150 Background: Skeletal related events (SREs) diminish quality of life (QOL) as well as overall survival (OS) in patients with bone metastases, a common event in breast, lung and prostate cancer. SREs can be reduced or delayed by the use of bisphosphonates. It is postulated that the radiopharmaceuticals, Strontium-89 (Sr89) and Samarium-153 (Sm153), when added to a bisphosphonate can decrease the incidence of SREs. Methods: RTOG 0517 randomized patients with breast, lung and prostate cancer and blastic bone metastases to either Zoledronic acid (ZA) alone or ZA plus a single standard dose of either Sr89 or Sm153. No limitations were placed on additional therapy such as chemotherapy or hormonal treatment. The projected median time to SRE [pathological bone fracture, spinal cord compression, surgery to bone, or radiation to bone] for the ZA arm was 10.4 months requiring 257 SRE events to detect a 33% relative reduction for the radiopharmaceutical arm in the time to development of an SRE with 90% power. Other study objectives included quality of life, pain control, OS and toxicity. Results: 261 patients (median age 68; 62% male; 55% prostate, 35% breast, 10% lung) were accrued from July 2006 through February 2011 (4.6 patients/month). Due to a lower than expected rate of SREs in the control (ZA) arm, the study was closed early and therefore did not reach the targeted accrual. 28 (17.4%) patients in the ZA arm and 27 (16.8%) in the radiopharmaceutical arm experienced an SRE. Median time to development of an SRE in the ZA and radiopharmaceutical arms was 11.60 and 16.74 months, respectively (p=.47). Median OS in the ZA arm and radiopharmaceutical arm was 15.95 and 11.18 months, respectively (p=0.12). Cox proportional hazards regression model showed that baseline characteristics, including gender, race, ethnicity, primary disease site or number of bone metastases, had no significant impact on OS. There was no difference in QOL parameters or toxicities between the two arms. Conclusion: Patients receiving ZA only experienced a much lower SRE rate than was hypothesized. The addition of Sr89 or Sm153 did not result in a difference in SREs, OS, or QOL

scholarly journals Combined Resistance and Aerobic Exercise Program Reverses Muscle Loss in Men Undergoing Androgen Suppression Therapy for Prostate Cancer Without Bone Metastases: A Randomized Controlled Trial

2010 ◽  
Vol 28 (2) ◽  
pp. 340-347 ◽  
Author(s):  
Daniel A. Galvão ◽  
Dennis R. Taaffe ◽  
Nigel Spry ◽  
David Joseph ◽  
Robert U. Newton
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Muscle Strength ◽  
Aerobic Exercise ◽  
Usual Care ◽  
Physical Function ◽  
Lean Mass ◽  
Exercise Program ◽  
Androgen Suppression

Purpose Androgen suppression therapy (AST) results in musculoskeletal toxicity that reduces physical function and quality of life. This study examined the impact of a combined resistance and aerobic exercise program as a countermeasure to these AST-related toxicities. Patients and Methods Between 2007 and 2008, 57 patients with prostate cancer undergoing AST (commenced > 2 months prior) were randomly assigned to a program of resistance and aerobic exercise (n = 29) or usual care (n = 28) for 12 weeks. Primary end points were whole body and regional lean mass. Secondary end points were muscle strength and function, cardiorespiratory capacity, blood biomarkers, and quality of life. Results Analysis of covariance was used to compare outcomes for groups at 12 weeks adjusted for baseline values and potential confounders. Patients undergoing exercise showed an increase in lean mass compared with usual care (total body, P = .047; upper limb, P < .001; lower limb, P = .019) and similarly better muscle strength (P < .01), 6-meter walk time (P = .024), and 6-meter backward walk time (P = .039). Exercise also improved several aspects of quality of life including general health (P = .022) and reduced fatigue (P = .021) and decreased levels of C-reactive protein (P = .008). There were no adverse events during the testing or exercise intervention program. Conclusion A relatively brief exposure to exercise significantly improved muscle mass, strength, physical function, and balance in hypogonadal men compared with normal care. The exercise regimen was well tolerated and could be recommended for patients undergoing AST as an effective countermeasure to these common treatment-related adverse effects.

scholarly journals Transurethral Resection of Prostate for the Treatment of Advanced Prostate Cancer and Bladder Outlet Infarction

1970 ◽  
Vol 1 (2) ◽  
Author(s):  
Chenglin Huang
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Endocrine Therapy ◽  
Transurethral Resection ◽  
Advanced Prostate Cancer ◽  
Control Group ◽  
Transurethral Resection Of Prostate ◽  
Study Group ◽  
Better Than

Objective: To investigate the feasibility of transurethral resection of prostate and the treatment of advanced prostate cancer and bladder outlet infarction, and to analyze the therapeutic effect. Methods: 34 patients with advanced prostate cancer admitted in our hospital from April 2014 to April 2014 were divided into control group (17 cases) with routine endocrine therapy. The study group (17 cases) underwent urethral resection surgery Combined with endocrine therapy, through the relevant indicators of prostate treatment were observed to explore the two groups of patients with therapeutic effect. Results: According to the related indexes of prostate treatment, the treatment effect of the study group was significantly better than that of the control group, and the data of the two groups were statistically significant (P<0.05). Conclusion: The treatment of advanced prostate cancer patients with endocrine combined with transurethral resection of the prostate can effectively treat the symptoms of bladder outlet infarction and improve the quality of life of patients. It has certain value in clinical treatment.

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