leuprolide and Erectile-Dysfunction

Treatment of localized prostate cancer (PC) is controversial. This is the first randomized study comparing an open surgery procedure (radical prostatectomy) with a combination of high-dose rate brachytherapy (2×10 Gy) and external beam radiotherapy (25×2 Gy) in PC patients in Sweden 1996-2001. The two randomization arms were compared regarding differences in patients-reported outcomes, such as complications and health-related quality of life (HRQoL).. The patients had localized/locally advanced PC, clinical category T1b-T3a, N0, M0 and PSA≤50 ng/ml. All underwent total androgen blockade (six months). Self-reported HRQoL and symptoms including urinary, bowel, and sexual side effects were investigated prospectively before randomization and 12 and 24 months after randomization. A total of 89 patients were randomized and completed the EORTC QLQ C-33 and EORTC PR-25 questionnaires.. Over the study period, there were no discernible differences in HRQoL, or complications between the two groups. Emotional functioning, however, improved statistically significantly over time, whereas Social functioning decreased, and financial difficulties increased. No statistically significant differences in group-by-time interactions were found. The survival rate was 76%. Only eight patients (9%) died of PC.. Open radical prostatectomy and the combined high-dose rate brachytherapy with external beam radiation appeared to be comparable in the measured outcomes. It was not possible to draw any conclusion on the efficacy of the two treatments due to insufficient power of the study.

Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Brachytherapy; Cost of Illness; Emotions; Erectile Dysfunction; Fecal Incontinence; Flutamide; Humans; Leuprolide; Male; Middle Aged; Neoplasm Staging; Prospective Studies; Prostatectomy; Prostatic Neoplasms; Quality of Life; Radiotherapy Dosage; Social Participation; Surveys and Questionnaires; Survival Rate; Sweden; Urinary Incontinence

It is not known whether short-term androgen-deprivation therapy (ADT) before and during radiotherapy improves cancer control and overall survival among patients with early, localized prostate adenocarcinoma.. From 1994 through 2001, we randomly assigned 1979 eligible patients with stage T1b, T1c, T2a, or T2b prostate adenocarcinoma and a prostate-specific antigen (PSA) level of 20 ng per milliliter or less to radiotherapy alone (992 patients) or radiotherapy with 4 months of total androgen suppression starting 2 months before radiotherapy (radiotherapy plus short-term ADT, 987 patients). The primary end point was overall survival. Secondary end points included disease-specific mortality, distant metastases, biochemical failure (an increasing level of PSA), and the rate of positive findings on repeat prostate biopsy at 2 years.. The median follow-up period was 9.1 years. The 10-year rate of overall survival was 62% among patients receiving radiotherapy plus short-term ADT (the combined-therapy group), as compared with 57% among patients receiving radiotherapy alone (hazard ratio for death with radiotherapy alone, 1.17; P=0.03). The addition of short-term ADT was associated with a decrease in the 10-year disease-specific mortality from 8% to 4% (hazard ratio for radiotherapy alone, 1.87; P=0.001). Biochemical failure, distant metastases, and the rate of positive findings on repeat prostate biopsy at 2 years were significantly improved with radiotherapy plus short-term ADT. Acute and late radiation-induced toxic effects were similar in the two groups. The incidence of grade 3 or higher hormone-related toxic effects was less than 5%. Reanalysis according to risk showed reductions in overall and disease-specific mortality primarily among intermediate-risk patients, with no significant reductions among low-risk patients.. Among patients with stage T1b, T1c, T2a, or T2b prostate adenocarcinoma and a PSA level of 20 ng per milliliter or less, the use of short-term ADT for 4 months before and during radiotherapy was associated with significantly decreased disease-specific mortality and increased overall survival. According to post hoc risk analysis, the benefit was mainly seen in intermediate-risk, but not low-risk, men. (Funded by the National Cancer Institute; RTOG 94-08 ClinicalTrials.gov number, NCT00002597.).

Topics: Aged; Aged, 80 and over; Androgen Antagonists; Antineoplastic Combined Chemotherapy Protocols; Combined Modality Therapy; Erectile Dysfunction; Flutamide; Follow-Up Studies; Gonadotropin-Releasing Hormone; Goserelin; Humans; Leuprolide; Male; Middle Aged; Multivariate Analysis; Prostate; Prostatic Neoplasms; Radiotherapy; Radiotherapy Dosage; Risk; Survival Rate

Between December 1991 and December 1993, 74 BPH patients with an increased operative risk and concomitant diseases such as diabetes mellitus and hypertension were submitted to a transurethral incision of the prostate (TUIP). After TUIP, patients were randomized to two different groups: group 1 was followed without additional treatment and group 2 received an LHRH analogue for the first 6 months of follow-up. With respect to transurethral resection of the prostate (TURP), TUIP has been shown to demonstrate a lower perioperative morbidity. This advantage has lent further support to this technique as a valid alternative for patients in poor general conditions who are at high risk with more invasive procedures. One of the limits of TUIP is the long-term effectiveness. Aim of this study was to ascertain whether in patients with BPH and an increased operative risk who require immediate and definitive treatment but with a low perioperative morbidity, the long-term effectiveness of TUIP can be stabilized by the administration of an LHRH analogue. At present postoperative follow-up ranges from a minimum of 24 months to a maximum 48 months (mean 38.4 months). Perioperative morbidity rate associated with TUIP was 8.1%. In the group randomized to combination therapy (TUIP + LHRH analogue), the clinical condition of the patients was not modified by LHRH analogue treatment and none of the patients withdrew from treatment. Loss of sexual potency occurred in all patients on LHRH analogue, however, none of these patients discontinued treatment for this reason. At the end of the cycle of hormone treatment, sexual potency returned to pretreatment values in 69.5% of patients after a mean of 3.2 months. In this study the objective efficacy of the treatment was evaluated using flow rate measurements, and the subjective assessment of outcomes, using the International Prostate Symptom Score. Statistically significant differences between the two groups (TUIP alone or TUIP + LHRH analogue) (p < 0.01) were reported at 6 months and were still maintained at 24 months of follow up. Results emerging from this investigation confirm that TUIP may be considered extremely safe procedure with low operative risk. In selected BPH patients who are at high risk, with a more invasive procedure and who must be submitted to immediate and definitive treatment, the association of an LHRH analogue seems to increase the long-term effectiveness of TUIP. Five year follow-up studies are still in progress

Topics: Aged; Antineoplastic Agents, Hormonal; Combined Modality Therapy; Erectile Dysfunction; Follow-Up Studies; Humans; Leuprolide; Male; Postoperative Complications; Prostatic Hyperplasia; Urodynamics

Study Type - Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Erectile dysfunction is a recognized complication of radical prostatectomy. Androgen deprivation therapy adversely impacts sexual function. Our study shows that the preoperative use of androgen deprivation therapy significantly reduces erectile function recovery after radical prostatectomy. The underneath pathophysiological mechanisms for this to occur are reviewed.. To define the impact of androgen deprivation therapy (ADT), undergone before radical prostatectomy (RP), on erectile function (EF) recovery.. A total of 38 consecutive patients presenting to a sexual medicine clinic after undergoing RP who had received ADT before RP (ADT+ group) were compared with a contemporary, age and comorbidity-matched cohort of 94 patients who did not receive ADT (ADT- group) before undergoing RP. Medical records were reviewed for demographics, comorbidity profiles and duration of ADT exposure. All the patients underwent Doppler penile ultrasonography within 6 months of RP and were administered the International Index of Erectile Function (IIEF) questionnaire. All the patients underwent evaluation of EF recovery. We analysed the incidence of venous leak (VL), mean IIEF EF domain score and proportion of men with EF domain scores ≥ 24 at 18 months after RP.. The mean age, comorbidity profiles, median Gleason score, median pre-treatment PSA level, and mean time to evaluation after RP were similar between the two groups. The median duration of ADT exposure in the ADT+ group was 3 months. The incidence of VL within 6 months of surgery was 60% for the ADT+ and 20% for the ADT- group (P < 0.001). Likewise, the IIEF EF domain scores and proportion of men with EF domain scores ≥ 24 at 18 months were significantly lower in the ADT+ group, even when controlled for nerve-sparing status.. Our data suggest that preoperative use of ADT adversely impacts EF outcomes and should therefore be avoided in the absence of robust data suggesting any oncological benefit.

Topics: Aged; Androgen Antagonists; Antineoplastic Agents, Hormonal; Combined Modality Therapy; Erectile Dysfunction; Humans; Leuprolide; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Preoperative Care; Prostatectomy; Prostatic Neoplasms

High-flow priapism (HFP) may occur secondary to perineal trauma, congenital arterial malformations, and iatrogenic insults. In cases that do not resolve spontaneously, standard management is by selective embolization, resulting in resolution rates as high as 78%; however, erectile dysfunction (ED) is a frequent complication, occurring in up to 39% of cases.. We report our use of androgen blockade (AB) to suppress nocturnal erections as an alternative treatment for HFP.. A retrospective review of all patients treated at our institution for HFP was undertaken. Included in this study were any patients treated with single- or combination-agent AB for HFP. Operative reports and medical records were examined to determine patient characteristics and outcomes. Treatment efficacy, side effects, and residual ED were assessed using a questionnaire.. The primary clinical outcomes assessed were resolution of HFP, tolerability, and side effects of treatment.. Seven patients with HFP were treated with AB. Priapism was a result of trauma in three patients and a persistent high-flow state after shunt procedures in four. Mean follow-up was 2 years (range 4 to 64 months). Therapy consisted primarily of 7.5 mg intramuscular monthly leuprolide injections, although bicalutamide and ketoconazole were also utilized as adjunct treatments. Therapy duration ranged from 2 months to 6 months and was discontinued after symptom resolution. One patient discontinued daily ketoconazole after 1 week because of severe hot flashes. The remaining six patients reported complete resolution of HFP. The primary complaints during therapy were decreased libido and fatigue. All patients reported some degree of ED during therapy. There was no reported residual ED or other hypogonadal symptoms on withdrawal of therapy.. AB is a successful option for treating HFP with acceptable side effects and return to baseline potency on treatment withdrawal.

Topics: Adult; Androgen Antagonists; Androgens; Anilides; Antineoplastic Agents, Hormonal; Erectile Dysfunction; Humans; Ketoconazole; Leuprolide; Male; Middle Aged; Nitriles; Penile Erection; Priapism; Retrospective Studies; Surveys and Questionnaires; Tosyl Compounds; Ultrasonography; Young Adult

There has been a resurgence of interest in cryosurgical ablation of the prostate for the treatment of carcinoma. This is due to recent advances in cryosurgical technology, which have resulted in relatively lower morbidity. The objective of this study was to evaluate the effectiveness of ultrasound-guided cryosurgical ablation of prostate carcinoma.. Eighty-three patients who had biopsy-proven prostate carcinoma underwent cryosurgical ablation of their entire prostate gland. The initial group of 12 patients had their procedures performed under ultrasound guidance only. The other 71 patients had cryosurgery performed with temperature monitoring in combination with ultrasound guidance. Twelve patients who had positive biopsies underwent a second cryosurgical procedure. All patients had prostate specific antigen (PSA) levels measured at 3, 6, 12, 18, 24, and 30 months after cryosurgery. Ultrasound-guided sextant biopsies were performed at 3-6, 12-18, and 24 months.. The median PSA dropped by 95%, from a preoperative value of 4.3 ng/mL to 0.2 ng/mL 30 months after cryosurgery. The authors experienced a high failure rate (positive biopsies) of 83% for the initial group of 12 patients who did not have temperature monitoring during the cryosurgical procedure. This was in contrast to a success rate of 90% (negative biopsies) for the next 71 patients, who did have temperature monitoring (P < 0.05, chi-square test). Twelve patients underwent a second cryosurgery, and the success rate for this group was 91% (11 of 12 patients). The combined success rate for both the first cryosurgery and the second was 94% (62 of 77 patients). Complications included urethral sloughing, urinary incontinence, impotence, bladder neck contracture, and bladder contracture. The majority of patients recovered rapidly from their cryosurgical procedures and were able to resume normal activities 3-4 weeks afterward.. These preliminary results demonstrate that cryosurgical ablation of the prostate is a viable treatment option for prostate carcinoma. In the authors' experience, ultrasound alone may not be adequate for monitoring the entire cryosurgical procedure. The authors found that temperature monitoring shortened their learning curve, enabled them to freeze prostate tissue more aggressively, and may have contributed to their overall success.

Topics: Aged; Carcinoma; Cryosurgery; Erectile Dysfunction; Humans; Leuprolide; Male; Middle Aged; Prostate-Specific Antigen; Prostatic Neoplasms; Thermometers; Urethral Diseases; Urinary Bladder Diseases; Urinary Incontinence