PROSTATE CANCER












  • References [2,3,5,6]
KNOWN RISK FACTORS FOR PROSTATE CANCER
Risk factor Comments
Age
  • Age is the number one risk factor for prostate cancer
  • Prostate cancer is rare in men under age 40
  • The incidence of prostate cancer rises rapidly after age 50
Race
  • African-Americans have the highest risk of prostate cancer. They also tend to have more aggressive cancers.
  • White men have a moderate risk for prostate cancer
  • Asian-Americans and Hispanics have the lowest risk of prostate cancer
Family history
  • Family history of prostate cancer is a risk factor for prostate cancer
  • Since a large number of men develop prostate cancer as they age, the number of affected relatives and the age of onset are important factors in quantifying the risk
  • Men with three or more affected relatives or at least two relatives who were diagnosed before the age of 55 are at greatest risk
BRCA2 mutations
  • BRCA2 mutations occur in families with a high incidence of breast and ovarian cancer. See BRCA gene testing for more.
  • BRCA2 mutations also confer a higher risk of prostate cancer
  • BRCA1 mutations likely increase the risk, but this is less clear

  • References [2,3,5,6]
POSSIBLE RISK FACTORS FOR PROSTATE CANCER
Risk factor Comments
Environment / Geography
  • Environmental factors appear to play a role in prostate cancer risk
  • Prostate cancer is more common in certain parts of the world (e.g. North America, northwestern Europe, Australia) and less common in others (e.g. Asia, Africa, Central America, South America). The reason is unclear, but screening frequency and longer life expectancy likely contributes to the measured differences.
Diet
  • A number of studies have looked at a link between prostate cancer and different dietary components (e.g. dairy, fat, alcohol, red meat, vitamin D, etc.). Results from these studies are often conflicting and no definitive link has been confirmed.
Agent Orange
  • Agent Orange was a defoliant chemical used in the Vietnam War
  • Some studies have suggested a link between Agent Orange exposure and prostate cancer while others have not









PCPT trial - Finasteride vs Placebo for Prostate Cancer Prevention, NEJM (2003) [PubMed abstract]
  • The Prostate Cancer Prevention Trial (PCPT) enrolled 18,882 men aged 55 years or older
Main inclusion criteria
  • Normal digital rectal exam
  • PSA ≤ 3 ng/ml
  • AUA BPH symptom score < 20
Baseline characteristics
  • Prostate cancer in first-degree relative - 28%
  • Age: 55 to 59 - 31% | 60 to 64 - 31% | ≥ 65 - 38%
  • Race White - 92% | Black - 3.5% | Hispanic - 2.8% | Other - 1.5%
Randomized treatment groups
  • Group 1 (9423 patients) - Finasteride 5 mg once daily
  • Group 2 (9457 patients) - Placebo once daily
  • All subjects underwent annual digital rectal exam and PSA blood draw
  • Prostate biopsy was recommended if the annual PSA level, adjusted for the effect of finasteride, exceeded 4.0 ng/ml or if the digital rectal examination was abnormal. Prostate biopsy was offered to all men who completed seven years of the study.
  • The finasteride group had their PSA adjusted by doubling the value in the first three years and then using a factor of 2.3 from year four on. Adjustments were made by an independent committee.
Primary outcome: Prevalence of prostate cancer during the seven years of the study
Results

Duration: After 81% of the men had completed 7 years of the study, the study was stopped early due to unlikely change in results
Outcome Finasteride Placebo Comparisons
Primary outcome 18.4% 24.4% RR 0.75, 95%CI [0.69 - 0.81], p<0.001
High-grade cancers (Gleason 7 - 10) 6.4% 5.1% p<0.001
Reduced volume of ejaculate 60% 47% p<0.001
Erectile dysfunction 67% 62% p<0.001
Loss of libido 65% 60% p<0.001
Gynecomastia 4.5% 2.8% p<0.001
BPH 5.2% 8.7% p<0.001
Increased urinary frequency or urgency 13% 16% p<0.001
Urinary retention 4.2% 6.3% p<0.001
TURP performed 1.0% 1.9% p<0.001
Prostatitis 4.4% 6.1% p<0.001
Urinary tract infection 1.0% 1.3% p<0.001

Findings: Finasteride prevents or delays the appearance of prostate cancer, but this possible benefit and a reduced risk of urinary problems must be weighed against sexual side effects and the increased risk of high-grade prostate cancer
REDUCE study - Dutasteride vs Placebo for Prostate Cancer Prevention, NEJM (2010) [PubMed abstract]
  • The REDUCE study enrolled 8231 men at high risk for prostate cancer
Main inclusion criteria
  • Age 50 - 75 years
  • PSA 2.5 (3 if > 60 years) to 10 ng/ml
  • Negative prostate biopsy within 6 months
Main exclusion criteria
  • Prostate cancer
  • More than 1 biopsy
  • ASAP
  • Prostate volume > 80 ml
  • Previous prostate surgery
Baseline characteristics
  • Average age 63
  • Average PSA - 5.9 ng/ml
  • Average free PSA - 17%
  • Race: White - 91% | Black - 2.3% | Hispanic - 4%
Randomized treatment groups
  • Group 1 (4105 patients): Dutasteride 0.5 mg once daily
  • Group 2 (4126 patients): Placebo
  • Subjects underwent a 10-core transrectal ultrasound-guided biopsy at 2 and 4 years
  • PSA levels were measured every 6 months and results were doubled in the dutasteride group
Primary outcome: Prostate cancer detected on biopsy after 2 or 4 years of treatment
Results

Duration: 4 years
Outcome Dutasteride Placebo Comparisons
Primary outcome (2 years) 13.4% 17.2% p<0.001
Primary outcome (4 years) 19.9% 24.9% p<0.001
Gleason 7 - 10 cancers (4 years) 6.7% 6.8% p=0.81
Acute urinary retention 1.6% 6.7% p<0.001
BPH-related surgery 1.4% 5.1% p<0.001
UTI 5.3% 8.8% p<0.001
Decreased libido 3.3% 1.6% p<0.001
Erectile dysfunction 9% 5.7% p<0.001
Gynecomastia 1.9% 1% p=0.002
  • During years 3 and 4, there were 12 tumors with a Gleason score of 8 to 10 in the dutasteride group, as compared with only 1 in the placebo group (P=0.003)

Findings: Over the course of the 4-year study period, dutasteride reduced the risk of incident prostate cancer detected on biopsy and improved the outcomes related to benign prostatic hyperplasia.





  • References [2,6,9,22]
USPSTF 2018 Recommendations
Age group Recommendation
55 - 69
  • Average-risk men - physicians should discuss the benefits and harms (see below) of screening with each patient and the decision to screen should be an individual one
  • African-Americans - recommendation is the same as average-risk men with the acknowledgement that screening in African-American men may have greater benefit and potentially greater harm than screening in average-risk men. Data from available trials is insufficient to draw conclusions either way.
  • Patients with family history - recommendation is the same as average-risk men. Men with the following family histories are most likely to benefit from screening although this has not been proven in clinical trials:
    • Multiple first-degree relatives with prostate cancer
    • First-degree relative who had advanced prostate cancer at diagnosis
    • First-degree relative who developed metastatic prostate cancer or who died from prostate cancer
≥ 70
  • DO NOT SCREEN
Screening interval
  • Makes no recommendation
DRE
  • Makes no recommendation
AUA 2015 Recommendations
< 40
  • DO NOT SCREEN
40 - 54
  • Average-risk men - DO NOT SCREEN
  • African-Americans and patients with a family history - physicians should discuss the benefits and harms (see below) of screening with each patient and the decision to screen should be an individual one
55 - 69
  • All men - physicians should discuss the benefits and harms (see below) of screening with each patient and the decision to screen should be an individual one
≥ 70
  • DO NOT SCREEN
Screening interval
  • Every two years is the preferred interval
DRE
  • Does not recommend for primary screening
ACS 2018 Recommendations
40 - 44
  • Men with very strong family history - consider screening men with more than one first-degree relative (father, brother, son) who had prostate cancer diagnosed at an early age (< 65 years old)
  • Decision to screen should be made after discussing the benefits and harms of screening (see below)
45 - 50
  • Men with very strong family history - consider screening men with more than one first-degree relative (father, brother, son) who had prostate cancer diagnosed at an early age (< 65 years old)
  • Men with strong family history - consider screening men with a first-degree relative (father, brother, son) who had prostate cancer diagnosed at an early age (< 65 years old)
  • African Americans - consider screening all African Americans
  • Decision to screen should be made after discussing the benefits and harms of screening (see below)
≥ 50
  • All men - consider screening all men with life expectancy ≥ 10 years
  • Decision to screen should be made after discussing the benefits and harms of screening (see below)
Screening interval
  • PSA < 2.5 ng/ml: may only need to screen every 2 years
  • PSA ≥ 2.5 ng/ml: screen annually
DRE
  • PSA is recommended screening test. DRE may be part of screening.
EAU 2017 Recommendations
All men
  • Physicians should discuss the benefits and harms (see below) of screening with each patient and the decision to screen should be an individual one
  • DO NOT SCREEN men with a life-expectancy of < 15 years
  • Offer PSA screening to men at elevated risk
    • Elevated risk is defined as any of the following:
      • Men > 50 years of age
      • Men > 45 years of age with a family history of prostate cancer
      • African-Americans > 45 years of age
      • Men with a PSA level of > 1 ng/mL at 40 years of age
      • Men with a PSA level of > 2 ng/mL at 60 years of age
Screening interval
  • Screening interval should be based on the initial PSA value
    • Recheck PSA every 2 years in the following patients:
      • Men with a PSA level of > 1 ng/mL at 40 years of age
      • Men with a PSA level of > 2 ng/mL at 60 years of age
    • Recheck PSA in 8 years in all other men
DRE
  • Makes no recommendation


  • Reference [2,8,9]
BENEFITS OF SCREENING FOR PROSTATE CANCER
Study Finding
PLCO trial Prostate cancer-related mortality after 10 years (death rate per 10,000 Person-Years)
  • Screened - 2.7, Control - 2.4 (RR 1.11; 95%CI [0.83 to 1.50])
ERSPC trial Prostate cancer-related mortality after a median of 9 years (death rate per 1000 Person-Years)
  • Screened - 0.35, Control - 0.41 (RR 0.85; 95%CI [0.73 to 1.00])
USPSTF trial review
  • In men 55 - 69 years old, prostate cancer screening may prevent up to 1 to 2 deaths from prostate cancer over approximately 13 years per 1,000 men screened
  • Screening programs may also prevent up to 3 cases of metastatic prostate cancer per 1,000 men screened over 13 years






  • For values ≤ 4 ng/ml, the median age of the cohort was 69 years. Data is from the placebo arm of the PCPT trial.
  • For values > 4 ng/ml, the average age of the cohort was 63 years
  • Rereneces [10,11]
Prevalence of Prostate Cancer by PSA Value
PSA value Prostate cancer on biopsy High-grade prostate cancer (Gleason ≥ 7) on biopsy
≤ 0.5 ng/ml 6.6% 0.82%
0.6 - 1 ng/ml 10% 1.0%
1.1 - 2.0 ng/ml 17% 2.0%
2.1 - 3.0 ng/ml 24% 4.6%
3.1 - 4.0 ng/ml 27% 6.7%
4.0 - 10 ng/ml 26% -
> 10 ng/ml 53% -

  • Clinically significant cancer defined as clinical stage ≥ cT2b, Gleason ≥ 7, or prostate-specific mortality
  • Data from screening arm of PLCO trial. Cohort size was 10,968 men. In the trial, men were offered annual PSA screening for 6 years.
  • References [23]
Incidence of Prostate Cancer Over 13 Years Based on PSA Drawn at Age 55 - 60 Years
PSA (ng/ml) Prostate cancer Clinically significant prostate cancer
≤ 0.49 0.7% 0.3%
0.5 - 0.99 2.2% 1.1%
1 - 1.99 8.6% 4%
2 - 2.99 21.1% 8.5%
3 - 3.99 33.5% 12.4%
≥ 4 49.9% 23.1%


  • Data drawn from a sample of 773 men with normal digital rectal exams and a total PSA between 4 - 10 ng/ml
  • Rereneces [13]
% free PSA Probability of cancer (50 - 64 years old) Probability of cancer (65 - 75 years old)
0 - 10 56% 55%
10 - 15 24% 35%
15 - 20 17% 23%
20 - 25 10% 20%
> 25% 5% 9%








  • Reference [6]
TUMOR (T) CATEGORIES
T score Clinical finding
T1
T1 - tumor cannot be felt or seen on imaging
  • T1a - cancer found incidentally on transurethral resection of the prostate (TURP) specimens. Less than 5% of specimens contain cancer.
  • T1b - cancer found incidentally on TURP specimens. More than 5% of specimens contain cancer.
  • T1c - cancer found on biopsy performed because of high PSA
T2
T2 - tumor can be felt on rectal exam or seen on imaging but appears confined to prostate
  • T2a - cancer is confined to one half or less of one side (left or right) of the prostate
  • T2b - cancer is in more than one half of one side of the prostate
  • T2c - cancer is in both sides of the prostate
T3
T3 - cancer has grown outside of the prostate
  • T3a - cancer is outside the prostate but not in the seminal vesicles
  • T3b - cancer has spread to the seminal vesicles
T4
T4 - cancer has grown into tissue outside the prostate (other than the seminal vesicles)
  • Other tissue may include urethral sphincter, rectum, bladder, and/or wall of the pelvis.
NODE (N) CATEGORIES
N score Clinical finding
NX NX - regional lymph nodes were not assessed
N0 N0 - no cancer found in regional lymph nodes
N1 N1 - cancer found in one or more regional lymph nodes
METASTASIS (M) CATEGORIES
M score Clinical finding
M0 MO - cancer has not spread beyond regional lymph nodes
M1
M1 - cancer has spread beyond regional lymph nodes
  • M1a - cancer has spread to lymph nodes outside the pelvis
  • M1b - cancer has spread to the bones
  • M1c - cancer has spread to other organs (e.g. lung, liver, brain) with or without bone involvement



  • PSA density is obtained by dividing the total PSA value by the prostate gland weight. Prostate gland weight is estimated with transrectal ultrasound.
  • Reference [17]
NCCN Prostate Cancer Risk Stratification Groups
Risk group Findings
Very low All of the following must be met:
  • Stage T1c or lower
  • Gleason score ≤ 6
  • PSA < 10 ng/ml
  • Fewer than 3 prostate biopsy cores positive and ≤ 50% cancer in each core
  • PSA density < 0.15 ng/ml/g
Low All of the following must be met:
  • Stage T1 - T2a
  • Gleason score ≤ 6
  • PSA < 10 ng/ml
Intermediate If any of the following are present, then risk is intermediate:
  • Stage T2b - T2c
  • Gleason score 7
  • PSA 10 - 20 ng/ml
High If any of the following are present, then risk is high:
  • Stage T3a
  • Gleason score 8 - 10
  • PSA > 20 ng/ml
Very high If any of the following are present, then risk is very high:
  • Stage T3b - T4
  • Primary Gleason pattern of 5
  • > 4 cores with Gleason score 8 – 10
Metastatic
  • N1 and/or M1



  • 1Data derived from cohort of 3183 U.S. men who were initially diagnosed in 1994-1995. 74% of subjects received either prostatectomy or radiation treatment.
  • 2Data from the National Cancer Institue SEER data
  • Reference [18,19]
Prostate cancer survival rates based on initial risk group
Risk group Mortality
Low risk1 3%
(14-year prostate cancer-specific mortality)
Intermediate risk1 7%
(14-year prostate cancer-specific mortality)
High risk1 18%
(14-year prostate cancer-specific mortality)
Metastatic2 70%
(5-year overall mortality)




  • Reference [17]
2017 NCCN Prostate Cancer Treatment Recommendations
Risk group Life expectancy Treatment
Very low risk ≥ 20 years One of the following:
10 - 20 years
< 10 years
  • Observation
Low risk ≥ 10 years One of the following:
< 10 years
  • Observation
Intermediate risk ≥ 10 years One of the following:
  • Radiotherapy ± ADT
  • Radical prostatectomy
< 10 years One of the following:
  • Radiotherapy ± ADT
  • Observation
High risk Does not apply One of the following:
  • External beam radiation + ADT
  • External beam radiation + brachytherapy ± ADT
  • Radical prostatectomy
Very high risk Does not apply One of the following:
  • External beam radiation + ADT
  • External beam radiation + brachytherapy ± ADT
  • Radical prostatectomy
  • ADT or observation
Regional metastasis
(N1, M0)
Does not apply One of the following:
  • External beam radiation + ADT
  • ADT
Metastatic
(M1)
Does not apply
  • ADT





  • 1Data from ProtecT study. Average age in the study was 62 years. External-beam radiation included neoadjuvant ADT for 3 to 6 months before and concomitantly with therapy. After 6 years of follow-up, ∼ 40% of patients in the active surveillance group had undergone prostatectomy or radiation.
  • 2Data from prospective cohort study. Median age in the cohort was 65 years. About 7% of the patients received ADT.
  • Reference [20,21]
Proportion of men with erections not firm enough for intercourse
Treatment Before treatment 6 months 1 year 2 years 5 years
Prostatectomy1
(N=553)
34% 88% 85% 81% 80%
External-beam radiation therapy1
(N=545)
32% 78% 62% 66% 73%
Brachytherapy2
(N=306)
36% 58% 54% 56% -
Active surveillance1
(N=545)
32% 48% 51% 53% 65%

Proportion of men with any degree of urinary incontinence in the ProtecT study
Treatment Before treatment 6 months 1 year 3 years 5 years
Prostatectomy 30% 71% 71% 68% 69%
Radiation therapy 31% 38% 38% 43% 48%
Active surveillance 28% 39% 42% 47% 47%

  • 2Data from prospective cohort study. Median age in the cohort was 65 years. About 7% of the patients received ADT.
  • Reference [20,21]
OTHER URINARY SYMPTOMS
Prostatectomy2
(N=603)
External-beam radiation2
(N=292)
Brachytherapy2
(N=306)
Before treatment 6 months 12 months 24 months Before treatment 6 months 12 months 24 months Before treatment 6 months 12 months 24 months
Dysuria 1% 1% 1% < 1% 1% 5% 1% 1% 1% 11% 11% 5%
Weak stream 12% 6% 3% 4% 13% 11% 12% 10% 7% 26% 18% 11%
Frequency 17% 14% 11% 10% 16% 19% 13% 14% 11% 31% 20% 20%
Incontinence (> 1 time/day) 4% 23% 16% 14% 6% 9% 8% 7% 5% 9% 6% 10%

  • Data from prospective cohort study. Median age in the cohort was 65 years. About 7% of the patients received ADT.
  • Reference [21]
BOWEL SYMPTOMS
Prostatectomy
(N=603)
External-beam radiation
(N=292)
Brachytherapy
(N=306)
Before treatment 6 months 12 months 24 months Before treatment 6 months 12 months 24 months Before treatment 6 months 12 months 24 months
Urgency 1% 3% 3% 2% 3% 12% 14% 16% 4% 14% 10% 9%
Frequency 1% 2% 1% < 1% 2% 9% 9% 10% 3% 9% 8% 7%
Incontinence < 1% 1% < 1% < 1% < 1% 4% 4% 2% < 1% 6% 4% 5%
Rectal pain 1% 3% 2% 2% 2% 5% 3% 4% 2% 5% 4% 4%


  • References [Manufacturer's PI, 17]
DRUGS USED IN ANDROGEN DEPRIVATION THERAPY
Drug Side effects of ADT
GnRH agonists
Leuprolide (Lupron®)
Goserelin (Zoladex®)
Triptorelin (Trelstar®)
Histrelin (Vantas®)
  • GnRH agonists only - Initial increase in testosterone over 2 - 3 weeks which may exacerbate bone pain and/or urinary tract obstruction
  • Hot flashes - up to 73%
  • Erectile dysfunction - may worsen
  • Gynecomastia / breast pain
  • Osteoporosis - Use FRAX tool with "secondary osteoporosis" checked to determine risk
  • Increased risk of diabetes or worsening of diabetes
  • Increased risk of cardiovascular disease
  • Increased cholesterol / triglyceride levels
  • Depression / fatigue / weight gain
  • Prolonged QT interval
GnRH antagonist
Degarelix (Firmagon®)












  • 1In high-risk men, PSA surveillance as frequently as every 3 months may be necessary to clarify disease status
  • 2In young, healthy men who are candidates for salvage therapy, a recurrence evaluation may be indicated for increases that are < 2 ng/ml
  • Reference [17]
Prostate cancer post-treatment surveillance recommendations
Initial treatment surveillance Recurrence
Prostatectomy or
external-beam radiation
(localized disease)
  • PSA every 6 - 12 months for 5 years then every year1
  • DRE every year, but may be omitted if PSA is undetectable
If patient had radical prostatectomy:
  • Detectable PSA that increases on 2 or more checks
If patient had external-beam radiation therapy:
  • PSA increase by ≥ 2 ng/ml above the nadir PSA2
N1 or M1 on ADT
  • Physical exam + PSA every 3 - 6 months
  • Bone scan initially and for symptoms as often as every 6 - 12 months
  • Further metastasis



ProtecT Study - Prostatectomy vs External-Beam Radiation vs Active Surveillance in Localized Prostate Cancer, NEJM (2016) [PubMed abstract]
  • The ProtecT study enrolled 1643 men with localized prostate cancer detected by PSA screening
Main inclusion criteria
  • Age 50 - 69 years
  • Confirmed localized prostate cancer
  • Able to receive any of the three treatments
Main exclusion criteria
  • Other malignancies besides small skin cancers
  • Serious cardiac problems in last 12 months (e.g. stroke, MI, CHF)
  • Kidney dialysis
Baseline characteristics
  • Average age 62 years
  • White race - 99%
  • Family history of prostate cancer - 7%
  • Median PSA - 4.8 ng/ml
  • Gleason scores: 6 - 77% | 7 - 21% | ≥ 8 - 2%
  • Clinical stage: T1c - 75% | T2 - 25%
Randomized treatment groups
  • Group 1 (545 patients) - Active surveillance
  • Group 2 (553 patients) - Prostatectomy
  • Group 3 (545 patients) - External beam radiation
  • In the active surveillance group, PSA levels were measured every 3 months in the first year and every 6 to 12 months thereafter. An increase of at least 50% during the previous 12 months triggered a review.
  • The external-beam radiation protocol included neoadjuvant ADT for 3 to 6 months before and concomitantly with therapy
Primary outcome: Prostate-cancer mortality at a median of 10 years of follow-up
Results

Duration: Median of 10 years
Outcome Surveillance Prostatectomy XRT Comparisons
Primary outcome (deaths per 1000 person-yr) 1.5 0.9 0.7 p=0.48
Overall mortality (deaths per 1000 person-yr) 10.9 10.1 10.3 p=0.87
Metastatic disease (cases per 1000 person-yr) 6.3 2.4 3.0 p=0.004
  • In the surgery and XRT groups, more than 85% of participants received a radical intervention (XRT and/or surgery)
  • In the active surveillance group, 55% of men eventually received radical treatment (prostatectomy - 49%, external-beam radiation - 33%, brachytherapy - 8%, nonprotocol radiotherapy - 9%, high-intensity focused ultrasound - 1%)

Findings: At a median of 10 years, prostate-cancer-specific mortality was low irrespective of the treatment assigned, with no significant difference among treatments. Surgery and radiotherapy were associated with lower incidences of disease progression and metastases than was active monitoring.
ProtecT Study 15-year Results, NEJM (2023) [PubMed abstract]
  • 15-year follow-up results from the ProtecT study were published in 2023 that included outcomes for 1610 (98%) of the original participants

Duration: Median of 15 years
Outcome Surveillance Prostatectomy XRT Comparisons
Death from prostate cancer 3.1% 2.2% 2.9% p=0.53
Overall mortality 22.7% 21.2% 21.1% p>0.05
Metastatic disease 9.4% 4.7% 5% p<0.05
  • At the end of the 15-year follow-up period, radical treatment (surgery or XRT) had been performed in 90.4% of the surgery group, 92.5% of the XRT group, and 61.1% of the surveillance group.

Findings: After 15 years of follow-up, prostate cancer–specific mortality was low regardless of the treatment assigned. Thus, the choice of therapy involves weighing trade-offs between benefits and harms associated with treatments for localized prostate cancer.

PRECISION study - MRI-Targeted Biopsy vs Standard Biopsy for Prostate Cancer Diagnosis, NEJM (2018) [PubMed abstract]
  • The PRECISION study enrolled 500 men with elevated PSA and/or abnormal DRE
Main inclusion criteria
  • Elevated PSA, abnormal DRE, or both
  • PSA ≤ 20 ng/ml
Main exclusion criteria
  • History of prostate cancer
  • Prior prostate biopsy
  • Contraindication to MRI
Baseline characteristics
  • Average age - 64 years
  • Median PSA - 6.6
  • Abnormal DRE - 15%
  • Family history of prostate cancer - 18%
Randomized treatment groups
  • Group 1 (252 patients): MRI-Targeted biopsy
  • Group 2 (248 patients): Standard biopsy
  • MRI-targeted biopsy was performed with ultrasound guidance where areas suspicious for prostate cancer on the MRI were targeted for biopsy
  • Standard biopsy was a 10-to-12–core, transrectal ultrasonography–guided biopsy
Primary outcome: Proportion of men with clinically significant cancer, defined as the presence of a single biopsy core indicating disease of Gleason score 3+4 (Gleason sum of 7) or greater
Results

Duration: 30 days
Outcome MRI Standard Comparisons
Primary outcome 38% 26% p=0.005
Clinically insignificant cancer 9% 22% p<0.001
  • In the MRI group, 28% of men had results that were not suggestive of prostate cancer so they did not undergo biopsy

Findings: The use of risk assessment with MRI before biopsy and MRI-targeted biopsy was superior to standard transrectal ultrasonography–guided biopsy in men at clinical risk for prostate cancer who had not undergone biopsy previously.