Proscar (Finasteride) - Summary

PROSCAR SUMMARY

Why your doctor has prescribed PROSCAR

PROSCAR (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5(alpha)-reductase, an intracellular enzyme that converts the androgen testosterone into 5(alpha)-dihydrotestosterone (DHT).

PROSCAR is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

• Improve symptoms
• Reduce the risk of acute urinary retention
• Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.

PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed >/=4 point increase in AUA symptom score).

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NEWS HIGHLIGHTS

Published Studies Related to Proscar (Finasteride)

PCPT: Evidence that finasteride reduces risk of most frequently detected intermediate- and high-grade (Gleason score 6 and 7) cancer. [2009.05]
OBJECTIVES: To determine the effect of finasteride relative to placebo on prostate cancer (PCa) risk at each individual Gleason score in the Prostate Cancer Prevention Trial using a post hoc generalization of a prespecified, exploratory, biopsy sampling density-adjusted analysis... CONCLUSIONS: After adjusting for biopsy sampling density, finasteride significantly reduced the PCa risk relative to placebo across multiple Gleason scores in the Prostate Cancer Prevention Trial, including the most frequently detected intermediate- and high-grade cancers (Gleason scores 6 and 7).

Effects of short-term finasteride on apoptotic factors and androgen receptors in prostate cancer cells. [2009.02]
PURPOSE: We explored the molecular correlates of the effect of finasteride on prostate tissue in patients undergoing radical prostatectomy... CONCLUSIONS: Finasteride administered 30 days before surgery appears to decrease the apoptotic factors caspase-7 and IGFBP-3 in cancer cells, while having little to no effect on caspase-3, insulin growth factor-1, bcl-2, p53 and p21. This short-term study may have interesting implications for interpreting Prostate Cancer Prevention Trial data on the molecular level. No differences were noted between the treatment and placebo groups in the expression of nuclear androgen receptor. However, decreased expression of androgen receptors was present in cancer cells compared to that in benign prostate cells in the 2 groups.

Long-term treatment with finasteride results in a clinically significant reduction in total prostate volume compared to placebo over the full range of baseline prostate sizes in men enrolled in the MTOPS trial. [2008.09]
PURPOSE: In the present analysis we examined data from the MTOPS (Medical Therapy of Prostatic Symptoms) trial to determine the effect of long-term finasteride treatment, either alone or in combination with doxazosin, on total prostate volume across the full range of baseline total prostate volume values in men enrolled in this study... CONCLUSIONS: In this MTOPS data analysis long-term (more than 4 years) treatment with finasteride, either alone or in combination with doxazosin, led to a consistent, clinically significant reduction in total prostate volume compared to placebo in patients with lower urinary tract symptoms and benign prostatic hyperplasia whose baseline prostate size ranged from relatively small (less than 25 to 30 ml) to enlarged (40 ml or greater).

Finasteride does not increase the risk of high-grade prostate cancer: a bias-adjusted modeling approach. [2008.08]
Finasteride taken for 7 years in the Prostate Cancer Prevention Trial (PCPT) reduced the risk of prostate cancer by 25%, but with an apparent increased risk of high-grade disease. Subsequent analyses found that finasteride biases toward improved prostate cancer detection and accuracy in prostate cancer grading at biopsy...

The effect of 5alpha-reductase inhibition with dutasteride and finasteride on bone mineral density, serum lipoproteins, hemoglobin, prostate specific antigen and sexual function in healthy young men. [2008.06]
PURPOSE: Dutasteride and finasteride are 5alpha-reductase inhibitors that dramatically decrease serum levels of dihydrotestosterone. Because androgens affect bone, lipids, hematopoiesis, prostate and sexual function, we determined the impact of 5alpha-reductase inhibitors on these end points... CONCLUSIONS: Profound suppression of circulating serum dihydrotestosterone induced by 5alpha-reductase inhibitors during 1 year does not adversely impact bone, serum lipoproteins or hemoglobin, and has a minimal, reversible effect on serum prostate specific antigen and sexual function in normal men. Circulating dihydrotestosterone does not appear to have a clinically significant role in modulating bone mass, hematopoiesis or lipid metabolism in normal men.

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Clinical Trials Related to Proscar (Finasteride)

A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Proscar in Men With Initial Negative Prostate Biopsies [Not yet recruiting]
Twenty percent of men with an initial negative prostate biopsy are found to have cancer on a repeat biopsy. finasteride (a 5-ARI) reduces prostate volume and improves the utility of PSA and DRE. thus, six months of finasteride may improve the detection rate of prostate cancer in men with an initial negative biopsy.

Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of The Prostate [Not yet recruiting]
Transurethral resection of the prostate (TURP) is a common treatment for benign prostatic hyperplasia (BPH). a common complication of TURP is blood loss. preliminary data suggest that preoperative finasteride, a 5a-reductase inhibitor, may reduce blood loss during TURP. however, no study has examined the effect of preoperative finasteride on clinical outcomes.

Fed Study of Finasteride Tablets 5 mg and Proscar® Tablets 5 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's finasteride 5 mg tablets and Merck's Proscar® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.

Fasting Study of Finasteride Tablets 5 mg and Proscar Tablets 5 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's finasteride 5 mg tablets to Merck's Proscar® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fasting conditions.

On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP) [Active, not recruiting]
Transurethral resection of the prostate (TURP) is a common treatment for benign prostatic hyperplasia (BPH). A common complication of TURP is blood loss. Preliminary data suggest that preoperative Finasteride, a 5 alpha-reductase inhibitor, may reduce blood loss during TURP. However, no study has examined the effect of preoperative Finasteride on clinical outcomes.

The study is a randomized, double-blind, placebo-controlled trial of preoperative Finasteride versus placebo in BPH patients undergoing TURP. Participants will be stratified by prostate volume (30 to 65 grams versus 66 to 100 grams) and randomly assigned to preoperative Finasteride or placebo. The primary end point is incidence of RBCT. Secondary end points are standard units of red blood cells transfused, variables related to perioperative bleeding (incidence of readmission, incidence of return to hospital, length of hospital stay), blood loss, change in serum hemoglobin, change in serum hematocrit, blood loss per gram of resected prostate tissue, operating time, change in AUA-SS, and change in HRQOL.

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PATIENT REVIEWS / RATINGS / COMMENTS

Proscar review by 67 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		bph
Dosage & duration:		one tablet taken daily for the period of 3 years
Other conditions:		gerd
Other drugs taken:		omeprazole
		Reported Results
Benefits:		my urination problems (urgency , frequency , etc ) practically disappeared and I no longer had get off my bed to urinate several times during the night
Side effects:		there were none
Comments:		I took one pill a day every evening with a glass of water after dinner .The treatment was supervised by a proctologist

Proscar review by 48 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		male pattern baldness
Dosage & duration:		1/4 of 5mg taken once per day for the period of ongoing
Other conditions:		none
Other drugs taken:		Occasional Viagra
		Reported Results
Benefits:		Decent hair growth and consistent prevention of futher hair loss.
Side effects:		Some sexual side effects, but can't be sure if it is the finasteride. At any rate, 1/4 of a 100mg Viagra seems to make sure that side effect is overcome.
Comments:		I've been taking finasteride generic (1-2 mg daily) for several years now, after taking Propecia for a number of years. It's definitely cheaper, and seems to work just as effectively.

Proscar review by 42 year old male patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Alopecia
Dosage & duration:		2.5mg taken once a day for the period of 11 years
Other conditions:		NOne
Other drugs taken:		None
		Reported Results
Benefits:		Reduction in Alopecia progression which began at age 21. Alopecia was very agressive through 20s until procecia introduction. Since then the condition has been slowed although not stopped.
Side effects:		Testicular discomfort at onset with a decrease in semen production. No other noticeable effects worth noting.
Comments:		Taken orally once a day. Usually at night.