Prostate cancer (PCa) in 696 hypogonadal men with and without long-term testosterone therapy (TTh): Results from a controlled registry study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5085-5085
Author(s):  
Ahmad Haider ◽  
Karim Sultan Haider

5085 Background: There is no evidence that TTh in men with hypogonadism increases PCa incidence or severity. A Canadian group recently found that long-term TTh decreased the risk of PCa diagnosis (Wallis et al., Lancet Diab Endocrinol 2016; 4:498). We assessed incidence and severity of PCa in hypogonadal men on long-term TTh (T-group) in comparison to an untreated hypogonadal control group (CTRL). Methods: 400 men with testosterone ≤350 ng/dL and symptoms received testosterone undecanoate 1000 mg every 3 months for up to 10 years. 296 hypogonadal men (57-74) opted against TTh. Median follow-up: 8 years. Total observation time covered more than 5,000 patient-years. Prostate volume (PV), PSA, weight and C-reactive protein (CRP) were measured and digital rectal examination/transrectal ultrasound performed before treatment initiation and then every 6-12 months. Biopsies were performed when indicated according to EAU guidelines. Results: In the T-group, PV increased slightly but significantly by 2.41 mL (p < 0.0001), PSA by 0.22 (NS). In CTRL, PV decreased slightly but significantly by -1.20 mL (p < 0.005), PSA by -0.38 (p < 0.0001). Weight dropped by 18.23% in the T-group and increased by 1.78% in CTRL, CRP decreased significantly in the T-group and remained unchanged in CTRL. In the T-group, 9 men (2.3%) were diagnosed with PCa. In CTRL, 15 (5.1%) were diagnosed with PCa. The incidence per 10,000 years was 29 in the T-group and 102 in CTRL. The mean baseline age of PCa patients was 65 years in the T-group and 65.5 in CTRL. Prostatectomy was performed in all men. In the T-group, all but 1 patient had a Gleason score ≤6, and all a predominant Gleason score of 3. Tumor grade was G2 in all 9 (100%), tumor stage T2a in 7 (78%) and T2b in 2 (22%) patients. In CTRL, Gleason score was > 6 in all 15 patients. 4 men had a predominant Gleason score of 3, 10 had 4, and 1 had 5. Tumor grade was G2 in 7 (46.7%) and G3 in 8 (53.3%) patients, tumor stage T2b in 1 (6.7%), T2c in 1 (6.7%), T3a in 1 (6.7%), T3b in 7 (46.7%) and T3c in 6 (50%) patients. Conclusions: In hypogonadal men, TTh may decrease PCa incidence compared to CTRL. PCa was less severe in the T-group. Weight loss and reduced inflammation by TTh may have contributed to our findings.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 167-167
Author(s):  
Ahmad Haider ◽  
Karim Sultan Haider

167 Background: There is no evidence that TTh in hypogonadal men increases PCa incidence or severity. A US-Scandinavian group recently found that men receiving TTh had lower risk of aggressive PCa (Loeb S et al., J Clin Oncol 2017; 35:1430-6). Methods: 412 men with testosterone ≤350 ng/dL and symptoms received testosterone undecanoate 1000 mg every 3 months for up to 12 years. 380 hypogonadal men (57-74) opted against TTh. Median follow-up: 9 years. Total observation time covered approximately 6,400 patient-years. Prostate volume (PV) and PSA were measured and digital rectal examination/transrectal ultrasound performed before treatment/observation initiation and then every 3-6 months (T-group) or once or twice per year (CTRL). Biopsies were performed when indicated according to EAU guidelines. Results: In the T-group, 11 men (2.7%) were diagnosed with PCa. In CTRL, 34 (8.9%) were diagnosed with PCa. The incidence per 10,000 years was 33 in the T-group and 108 in CTRL. The mean baseline age of PCa patients was 65.2 years in the T-group and 64.3 in CTRL. All PCa diagnoses in the T-group were made within the first 18 months of treatment initiation. In CTRL, PCa was diagnosed at any time during the observation time. In the T-group, radical prostatectomy was performed in all men. All but 1 patient had a Gleason score (GS) ≤6, and all but 1 a predominant GS of 3. Tumor grade was G2 in all 11 (100%), tumor stage T2a in 7 (64%), T2b in 3 (27%), and T2c in 1 (9%) patient(s). In CTRL, radical prostatectomy was performed in all but 6 patients. GS was > 6 in all 34 patients. 7 men had a GS of 7, 17 a GS of 8, and 10 a GS of 9. 2 men had a predominant Gleason score of 3, 22 had 4, and 10 had 5. Tumor grade was G2 in 6 (17.6%) and G3 in 28 (82.4%) patients, tumor stage T2c in 1 (0.3%), T3a in 3 (8.8%), T3b in 13 (38.2%) and T3c in 17 (50%) patients. In CTRL, biochemical recurrence occurred in 8 (23.5%) patients. These patients received androgen deprivation therapy (ADT). 10 (29.4%) patients died of whom 5 were on ADT. In the T-group, there were no biochemical recurrences or deaths during the observation time. Conclusions: In hypogonadal men, TTh may decrease PCa incidence compared to CTRL. PCa was less severe in the T-group.


2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 33-33
Author(s):  
Ahmad Haider ◽  
Karim Sultan Haider

33 Background: Despite persisting concerns, there is no evidence that TTh in men with hypogonadism increases PCa incidence or severity. Rather, a Canadian group recently found that long-term TTh decreased the risk of PCa diagnosis (Wallis et al., Lancet Diab Endocrinol 2016; 4:498). We assessed incidence and severity of PCa in hypogonadal men on long-term TTh (T-group) in comparison to an untreated hypogonadal control group (CTRL). Methods: 375 men (age range: 33-70) with testosterone ≤ 350 ng/dL and symptoms received testosterone undecanoate 1000 mg every 3 months for up to 10 years. 296 hypogonadal men (57-74) opted against TTh. Median follow-up: 7 years. Prostate volume (PV), PSA, weight and C-reactive protein (CRP) were measured and digital rectal examination/transrectal ultrasound performed before treatment initiation and then regularly every 3-6 months. Biopsies were performed when indicated according to EAU guidelines. Results: In the T-group, PV increased slightly but significantly by 2.41 mL (p < 0.0001), PSA by 0.22 (NS). In CTRL, PV decreased slightly but significantly by -1.20 mL (p < 0.005), PSA by -0.38 (p < 0.0001). Weight dropped by 18.23% in the T-group and increased by 1.78% in CTRL, CRP decreased significantly in the T-group and remained unchanged in CTRL. In the T-group, 8 men (2.1%) were diagnosed with PCa. In CTRL, 12 (4.1%) were diagnosed with PCa. The incidence per 10,000 years was 32 in the T-group and 64 in CTRL. The mean baseline age of PCa patients was 65 years in both groups. Prostatectomy was performed in all men. In the T-group, all patients had a Gleason score ≤ 6 and a predominant Gleason score of 3. Tumor grade was G2 in all 8 (100%), tumor stage T2a in 6 (75%) and T2b in 2 (25%) patients. In CTRL, Gleason score was > 6 in all 12 patients. Three men had a predominant Gleason score of 3, 8 had 4, and 1 had 5. Tumor grade was G2 in 5 (41.7%) and G3 in 7 (58.3%) patients, tumor stage T2b in 1 (8.3%), T2c in 1 (8.3%), T3b in 4 (33.3%) and T3c in 6 (50%) patients. Conclusions: TTh in hypogonadal men regularly monitored may decrease incidence of PCa compared to hypogonadal CTRL. PCa was less severe in the T-group. Weight loss and reduced inflammation by TTh may have contributed to our findings.


2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 304-304
Author(s):  
Ahmad Haider ◽  
Karim Sultan Haider

304 Background: Guidelines by AUA and EAU state that there is no evidence for an increased PCa risk for testosterone (T) treatment in hypogonadal men. Methods: In a registry study initiated in 2004 in a urology practice, 428 hypogonadal men (T≤350 ng/dL) received T undecanoate 1000 mg every 3 months following an initial 6-month interval for up to 13 years (T-group). 393 hypogonadal men (age range 51-74) opted against TTh (CTRL). Suspicion of or active PCa was excluded by transrectal ultrasound, digital rectal examination and PSA before treatment/observation initiation. Examinations were repeated between one and four times per year. Biopsies were performed when indicated according to EAU Guidelines. Results: In the T-group, 12 (2.8%) , in CTRL, 42 men (10.9%) were diagnosed with PCa. The mean baseline age of PCa patients was 64.9 years in the T-group and 64 in CTRL.In the T-group, the average time span between day of first injection and positive biopsy was 14.2 months (range: 5-18). No patient was diagnosed with PCa beyond 18 months of TTh. In CTRL, PCa was diagnosed at any time during the observation time. In the T-group, radical prostatectomy (RP) was performed in all men. All but 3 patients had Gleason score (GS) ≤6, and all but 1 had a primary GS of 3. Tumor grade was G2 in all 12 (100%), tumor stage T2a in 7 (58%), T2b in 3 (25%), and T2c in 2 (17%) patients. All but 2 patients are back on TTh after an average time of 25 months. In CTRL, RP was performed in all but 6 patients who received radiation therapy (RT). GS was ≤6 in 2 patients, 7 men had a GS of 7, 21 a GS of 8, and 12 a GS of 9. 4 men had a primary Gleason score of 3, 29 had 4, and 9 had 5. Tumor grade was G2 in 9 (21%) and G3 in 33 (79%) patients, tumor stage T2a in 2 (5%), T2c in 1 (2%), T3b in 15 (36%) and T3c in 24 (57%) patients. In CTRL, biochemical recurrence occurred in 11 (26%) patients. These patients received androgen deprivation therapy (ADT). 12 (34%) patients died of whom 7 were on ADT. In the T-group, no biochemical recurrences or deaths occurred during the observation time. Conclusions: Less PCa occurred and severity was lower in testosterone-treated hypogonadal patients compared to untreated hypogonadal controls.


2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 17-17
Author(s):  
Ahmad Haider

17 Background: Concerns regarding the safety of testosterone treatment, particularly regarding prostate cancer (PCa) in middle-aged and elderly men, still hamper the use of testosterone in hypogonadal men. In this study, we investigated prostate parameters incl. incidence of PCa in hypogonadal patients on long-term treatment with TU. Methods: In a prospective, cumulative registry study, 340 men (age: 57.37 ± 7.03 years) with testosterone ≤12.1 nmol/L received TU 1,000 mg every 12 weeks following an initial interval of 6 weeks for up to 7 years. Prostate volume (PV) and PSA were measured and digital rectal examination (DRE)/ transrectal ultrasound (TRUS) performed before treatment initiation and then regularly every 3-6 months. In case of suspected PCa, biopsies were performed. Results: PV increased from 28.96 ± 10.41 to 29.88 ± 13.85 ml by model-adjusted 2.59 ± 0.2 ml (p<0.0001). This increase was statistically significant compared to the previous year for the first four years. PSA increased from 1.74 ± 0.94 to 1.96 ± 1.03 ng/ml by model-adjusted 0.23 ± 0.52 ng/ml (p<0.0001). 53 biopsies were performed in testosterone-treated patients. Of these, 5 (9.4%) were positive and 48 (90.6%) negative. The proportion of PCa in testosterone-treated patients in our registry study was 1.5% with an incidence of 30.7 per 10,000 patient years. In hypogonadal patients without testosterone treatment, 314 biopsies were performed. Of these, 111 (35.4%) were positive and 203 (64.6%) negative. In eugonadal patients, 584 biopsies were performed. Of these, 263 (40.4%) were positive and 321 (55%) negative. In total, 951 prostate biopsies were performed in our practice from 2004 through 2013, of which 379 (39.9%) were positive and 572 (60.1%) negative. Conclusions: Long-term treatment with TU in hypogonadal men undergoing regular monitoring according to EAU guidelines does not increase the incidence of PCa.


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 50-50
Author(s):  
Ahmad Haider ◽  
Karim Sultan Haider

50 Background: Testosterone therapy (TTh) in middle-aged and elderly men is still associated with concerns regarding prostate cancer (PCa). In this registry study, we investigated the incidence of PCa in hypogonadal patients on long-term treatment with TU in comparison to an untreated hypogonadal control group (CTRL). Methods: In a cumulative registry study, 360 men (mean age: 57.37±7.29 years, range: 33-70) with testosterone (T) ≤12.1 nmol/L received TU 1000 mg every 12 weeks following an initial interval of 6 weeks for up to 8 years. 296 hypogonadal men (mean age: 64.79±4.28 years, range: 57-74) decided against TTh, mainly due to financial reasons. Prostate volume (PV) and PSA were measured and digital rectal examination (DRE)/ transrectal ultrasound (TRUS) performed before treatment initiation and then regularly every 3-6 months. Biopsies were performed when indicated according to EAU guidelines. Results: From baseline to 8 years, PV increased from 29.24±10.38 to 31.13±11.45 ml in the T group and remained stable from 34.45±5.89 to 33.51±12 in CTRL. PSA increased slightly from 1.74 ± 0.93 to 1.83±0.93 ng/ml in the T group and remained stable from 2.25±1.34 to 2.19±1.17 in CTRL. In T-treated patients, 7 men (1.9%) were diagnosed with PCa. In the control group, 12 (4.1%) were diagnosed with PCa. The incidence per 10,000 years was 30.05 in the T group and 63.54 in CTRL. The mean age of PCa patients was 64 years in the T group and 65 years in CTRL. All patients underwent radical prostatectomy. The predominant Gleason score was 3 in all patients in the T group, lymph nodes and surgical margins were negative. In CTRL, three men had a predominant Gleason score of 3, 8 had 4, and 1 had 5. 7 patients had positive lymph nodes and no patient had a positive surgical margin. Conclusions: Long-term treatment with TU in hypogonadal men undergoing regular monitoring according to EAU guidelines does not increase the incidence of PCa in comparison to an untreated hypogonadal CTRL group. PCa was more severe in the CTRL group.


PEDIATRICS ◽  
1985 ◽  
Vol 76 (1) ◽  
pp. 52-63
Author(s):  
Cesare T. Lombroso ◽  
Yoichi Matsumiya

Thirty-three full-term neonates were ranked blindly on a scale ranging from the least to the highest "risk" for future neurologic complications on the basis of available perinatal biographies, tests, and examinations performed during the newborn period. Four prolonged polygraphic-behavioral recordings were obtained one week apart beginning at ten days after birth. Five waking and sleep states were scored in each session as percentages of total observation time, giving a total of 20 scores for each baby to be subjected to analysis of variance. These measures also provided individual profile consistency or variability in maintaining waking-sleep states over the selected period of postnatal time. The whole cohort, except three infants who could not be followed adequately, was then reexamined periodically over a period ranging from 3 to 4 years (±6 months) for neurologic and developmental assessments. Except for two scores that produced a low level of statistical significance (P &lt; .05), the other 18 scores were found to be not associated with long-term outcomes. Even the first two scores were not satisfactory discriminators for the outcome of the individual babies. However, when coefficients of concordance (W) were computed from each individual baby profile, significant statistics (P &lt; .001) emerged to indicate good correlations between high or low W values in the newborn period and long-term outcomes. All 17 newborns who had W scores greater than 0.9 were found to be normal at follow-up regardless of the poor ranking given several of them during the newborn period. Among the 13 newborns who had W scores less than 0.9, 11 had a poor clinical outcome at follow-up, though several had been ranked initially as falling within the least "risk" group.


1993 ◽  
Vol 78 (2) ◽  
pp. 205-215 ◽  
Author(s):  
George T. Tindall ◽  
Nelson M. Oyesiku ◽  
Nelson B. Watts ◽  
Richard V. Clark ◽  
James H. Christy ◽  
...  

✓ The results of transsphenoidal adenomectomy for growth hormone (GH)-secreting pituitary adenomas in acromegaly performed over a 17-year period were analyzed retrospectively to determine which preoperative factors significantly influenced the long-term surgical outcome. These variables were then used to develop a logistic regression model to determine the probability of surgical failure. The series consisted of 103 patients. Long-term follow-up study (mean duration 102 ± 64 months) was performed to derive outcome analysis and determinants of failure. Surgical control was defined as a long-term postoperative serum basal GH level of less than 5 µg/liter, a long-term postoperative serum somatomedin C (SM-C) level of less than 2.2 U/ml, and a favorable clinical response. Eighteen (17.5%) patients did not meet these criteria. The overall control rate by the GH criteria was 81.3% and by the SM-C criteria 76.2%. By multivariate logistic regression analysis, tumor stage was the strongest predictor of outcome (p < 0.05). The preoperative GH level, tumor grade, and preoperative SM-C level were significant univariate predictors (p < 0.05). There were statistically significant differences in mean preoperative GH and SM-C levels (p < 0.05, t-test) and tumor stage (p < 0.05, chi-squared test) between patients whose acromegaly was controlled by surgery and those whose acromegaly was not. Furthermore, estimates were derived of the probability of surgical failure based on preoperative GH level, preoperative SM-C level, and tumor grade and stage. The authors believe these findings will enhance clinical decision-making for neurosurgeons considering transsphenoidal microsurgery in patients with acromegaly.


2009 ◽  
Vol 56 (2) ◽  
pp. 17-21 ◽  
Author(s):  
T. Pejcic ◽  
J. Hadzi-Djokic ◽  
B. Markovic ◽  
D. Dragicevic ◽  
B. Glisic ◽  
...  

Objectives: To estimate the ratio between urinary prostate specific antigen (uPSA) and tumor volume after prostate biopsy. Methods: From 2000 to July 2008, uPSA concentration was determined in 60 patients with clinically organ-confined prostate cancer (PCa). All patients underwent six-area transrectal ultrasound (TRUS) - guided biopsy, with at least 12 biopsy cores. Single pathologist determined tumor grade (G), Gleason score (GS), the percentage of tumor infiltration (% TI) and the percentage of positive cores (% PC) in all biopsy cores. Additionally, relative tumor-biopsy volume (RTV) was calculated by multiplying % PC, % TI and prostate ultrasound- derived volume (Vol). Forty-one patients underwent retropubic radical prostatectomy (RRP), while 19 patients underwent radiation therapy. Results: Average uPSA was 308.6+311.9 ng/ml (range 0.06-988 ng/ml), average PSA was 9.7+ 5.5 ng/ml (range 1.2-24.3 ng/ml), tumor grade 1.7+ 0.8, Gleason score 5.2 + 1.3, the percentage of tumor infiltration 27.6+21.8 %, and the percentage of positive cores, 52.2+30.7 %. Average RTV was 6.3+ 8.4 ml (0.29-56 ml). All patients were divided in two groups: I, with RTV 4 ml and II, with RTV = 4 ml. The patients with RTV 4 ml had lower G (1.4 0.6 vs. 2.1+0.8, p=0.0002), lower GS (4.5+1 vs. 5.8+1.3, p=0.003) and higher uPSA (389.4+340.8 vs. 193.1 +229.7, p=0.014). There were no differences in serum PSA levels between the groups. Conclusion: Relative tumor-biopsy volume (RTV) is useful parameter in the preoperative assessment of tumor volume. Patients with higher RTV had significantly higher G and GS. However, these patients had significantly lower uPSA. This phenomenon could be the consequence of compromised PSA drainage from the peripheral zone of the prostate, caused by the tumor.


2020 ◽  
Vol 2020 ◽  
pp. 1-13
Author(s):  
Fatemeh Hosseini Mojahed ◽  
Amir Hossein Aalami ◽  
Vahid Pouresmaeil ◽  
Amir Amirabadi ◽  
Mahdi Qasemi Rad ◽  
...  

Aim. Biochemical markers, including microRNAs (miRs), may facilitate the diagnosis and prognosis of breast cancer. This study was aimed at assessing serum miR-155 expression in patients with breast cancer and receptors. Methods. This case-control study was conducted on 36 patients with breast cancer and 36 healthy individuals. After RNA extraction from the patient’s serum, cDNA was synthesized. The expression of miR-155 was measured using RT-qPCR. Demographic and histochemical data were extracted from patient documents. Data were analyzed using the Statistical Package for the Social Sciences (SPSS) software. Results. The mean age of subjects in breast cancer and control groups was 47.64±8.19 and 47.36±7.52 years, respectively. The serum miR-155 expression was higher in the cancer group (1.68±0.66) compared to the control group (p<0.0001). There was a significant relationship between serum miR-155 expression and the tumor grade (p<0.001), tumor stage (p<0.001), and tumor size (p<0.001) of the patients. However, no relationship between miR-155 expression and the presence of lymph node involvement (p=0.15), HER2 (p=0.79), Ki-67 (p=0.9), progesterone receptor (p=0.54), and estrogen receptors (p=0.84) was found. The ROC curve analysis showed that the AUC was 0.89 (77.78% sensitivity and 88.89% specificity), and the cutoff was 1.4 (Youden index: 0.6667) for detecting breast cancer. Conclusion. The findings of this study revealed that serum miR-155 may serve as a potential noninvasive molecular biomarker for breast cancer diagnosis and can help predict the grade of the disease.


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