Abstract
Background
At Bugando Medical Centre, prostate cancer contributes to 39% of all cancers in male patients admitted to the Oncology department, and the majority have high Gleason grades. Although Prostate-specific antigen density (PSAD) has been shown to improve the diagnostic accuracy of prostate cancer and to triage patients for prostate biopsy, there is a significant variation across geographical locations.
Methods
A hospital-based cross-sectional study among patients with prostate-related urinary symptoms at Bugando Medical Centre, Mwanza, Tanzania. The study analyzed prostate-specific antigen levels, prostate volume, and total PSA using Maglumi 2000 and a computer system. Histopathological examination involved transrectal biopsy, TURP, and open prostatectomy. The optimal cutoff for PSA density was determined using the receiver operating characteristic curve.
Results
Of the 287 patients, the overall mean age of 71.2 (± 10.2) years. 99 (34.5%) participants were diagnosed with prostate cancer. The area under the curve for prostate-specific antigen density and PSA was 0.9094 (0.8761–0.9426) and 0.8932 (0.8569–0.9295), respectively. The PSAD optimal cut-off was 0.23ng/ml2, giving sensitivity of 86.9% and specificity of 82.4% for prostate cancer prediction. Using this cutoff reduces prostate biopsies by 54.5%. There was a weak positive correlation (Spearman’s rho (ρ) = 0.2456) between prostate-specific antigen density and Gleason grade groups.
Conclusions
The correlation between PSAD and Gleason grade groups observed in this study suggests that higher PSAD is associated with more aggressive cancer. This makes PSAD a valuable tool in guiding biopsy decisions, risk stratification, and treatment planning in patients with prostate-related urinary symptoms.
Supplementary Information
The online version contains supplementary material available at 10.1186/s12894-026-02101-9.
Keywords: Cut-off value, Gleason score, Prostate cancer, Prostate-specific antigen density
Background
Prostate cancer is the second most common cancer in men worldwide and is estimated to have almost 1.4 million new cases yearly and cause 375,000 deaths worldwide [1]. Katabalo et al. found that prostate cancer contributed to 39% of all cancers in male patients admitted to the Oncology department at Bugando Medical Centre (BMC) for 4 years, and the majority had a high Gleason grade [2]. Prostate cancer was incidentally found in 21.71% of patients in whom transrectal resection of the prostate (TURP) was performed due to clinical suspicion of benign prostate hyperplasia (BPH) [3]. Patients with prostate diseases, whether benign or malignant, often present in urology clinics and other health facilities with lower urinary tract symptoms (LUTS), which are objectively assessed by using the International Prostate Symptom Score (IPSS) [4–8].
Prostate biopsy is needed for histopathological examination, which is the gold standard [9, 10]. Prostate cancer is usually suspected based on digital rectal examination (DRE) and/or PSA levels. The prostate-specific antigen (PSA) level of >4ng/mL has been used as the cutoff with high sensitivity but low specificity [11–13]. Prostate-specific antigen density (PSAD) has been shown to improve the diagnostic accuracy of prostate cancer [14–17]. PSAD is calculated using the two major parameters, which are total serum PSA and measured prostate volume [16–20]. The higher the PSAD, the more likely it is that the patient has prostate cancer [21]. However, there are variations in PSA and PSAD across different populations in the world [15, 17, 20, 22]. At BMC, the decision for biopsy depends on the level of serum PSA and clinical features. This study aimed to ascertain the PSAD cutoff value that would enhance the clinical judgment and decision-making for prostate biopsy in patients presenting with LUTS at BMC.
Methods
This was a hospital-based cross-sectional study that was conducted among men attending the BMC Urology department with LUTS and indicated for biopsy. The study aimed to determine the utility of prostate-specific antigen density in the detection of prostate cancer and its correlation with the Gleason grade groups in patients with prostate-related urinary symptoms at BMC. The study included male patients presenting with lower urinary tract symptoms at Bugando Medical Centre urology clinic, but excluded those who had undergone hormonal or orchidectomy management for prostate diseases and those who had undergone surgery to reduce prostate volume. BMC is a Lake Zone referral hospital with a catchment area of 17 million people with a 1000-bed capacity. The urology department of BMC performs about 180 urological procedures per month, among which 75% are related to prostate diseases. The BMC Pathology department receives an average of 7000 tissue biopsies per year and a monthly average of 130 prostate samples from the BMC Urology department. The study was conducted over seven months from October 2023 to May 2024. The 364 participants consented to participate, but only 287 patients met the inclusion criteria. The sample size was calculated using Buderer’s formula by using the expected sensitivity set at 83% and specificity 75% based on the estimates from previous studies.
Serum PSA and Prostate Volume: A 4 ml blood sample in a red top Vacutainer tube for total serum PSA was taken before manipulation of the prostate, which was further analysed by Maglumi 2000 using the chemiluminescence technique at BMC central laboratory. The venipuncture was performed by experienced laboratory scientists at Central Pathology Laboratory. Results of transabdominal ultrasound of the prostate were obtained in the radiology department of BMC by using a curvilinear transducer, measuring the length x height x width of the prostate to obtain the volume, which was calculated by the inbuilt computer system. The PSAD (ng/ml2) was further calculated = PSA (ng/ml) / prostate volume (ml).
Prostate biopsies: After informed consent was obtained, transrectal core biopsies were obtained by using a 16–18FG Tru-cut needle, and 8–12 cores were obtained from each prostate. Transurethral prostate resection and open prostate were fixed in 10% neutral buffered formalin fixative. Antibiotics (ciprofloxacin) were given as prophylaxis after the procedure.
Histopathology procedure: The biopsies were fixed in 10% neutral buffered formalin for 48 to 72 h, sectioned according to the College of American Pathologists’ protocol, and processed using the automatic tissue processor. Sections were cut at 3–4 μm using a rotary microtome, stained with routine H&E, mounted with DPX, and cover-slipped.
Histopathology interpretation: The prepared slides were examined under the microscope (Nikon, model Eclipse E400) independently first by the investigator and then by two board-certified pathologists to ensure accurate agreement on the final diagnosis and grading. The interpretation and grading of prostate cancer was according to the Gleason grading system.
Data were collected using a pre-coded structured questionnaire. Variables included in the questionnaire were demographic data such as age, marital status, education level, and residence, clinicopathological data like prostate volume, PSA level, PSAD, and histopathological patterns. Then entered into Microsoft Excel 2016, cleaned, coded, and then transferred into STATA version 13.0 software for analysis. Categorical variables were summarized into proportions and percentages, while numerical variables were in mean with standard deviation or median with the interquartile range, depending on their distribution. Mann-Whitney U test, Pearson chi-square test, and Student’s t-test were used to compare the data in groups with and without prostate cancer. By using the Receiver operating characteristic curve (ROC), the AUC, sensitivity, and specificity of PSAD were determined for predicting prostate cancer. The correlation between PSAD and Gleason grade groups was determined using Spearman’s rank correlation. The p-value of less than 0.05 for all statistical tests was considered statistically significant. Ethical approval for this study was obtained from the joint CUHAS/BMC Research Ethics and Review Committee (CREC/718/2023).
This study was designed and reported in accordance with the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines to ensure transparency and completeness in reporting observational research.
Results
Socio-demographic characteristics of the patients
A total of 287 patients were included in the study, with the overall mean age of 71.2 (± 10.2) years, and the majority, 156 (54.4%), were 70 years and above (Table 1).
Table 1.
Socio-demographic characteristics of study participants (N = 287)
| Variable | Frequency (Percentage) |
|---|---|
| Age (years) | |
| Mean (SD) | 71.2 (10.2) |
| Age groups (years) | |
| 40–49 | 4 (1.4) |
| 50–59 | 28 (9.8) |
| 60–69 | 99 (34.5) |
| ≥ 70 | 156 (54.4) |
Clinicopathological characteristics of study participants
Regarding the IPSS score, most patients 270 (94.1%) had severe LUTS on presentation to the hospital with a median IPSS of 24 [22–26]. The median PSA level was 12.8 (4.1–32) ng/ml, while the median PSAD was 0.15 (0.067–0.41) ng/ml². The majority of the prostate biopsies, 201 (70.0%), were by TURP, and the majority of the patients, 188 (65.5%), had benign prostate disease, whereas 99 (34.5%) had prostate cancer on histopathology evaluation (Table 2).
Table 2.
Clinicopathological characteristics of study participants (N = 287)
| Variable | Frequency (Percentage) | Median (IQR) |
|---|---|---|
| IPSS for LUTS | 24 (22–26) | |
| Moderate | 17 (5.92) | |
| Severe | 270 (94.08) | |
| PSA | 12.2 (4.1–32.0) | |
| Prostate volume | 66 (47–104) | |
| PSAD | 0.15 (0.06–0.39) | |
| Type of biopsy | ||
| TURP | 201 (70.03) | |
| Prostatectomy | 2 (0.70) | |
| Tru-cut Cores | 84 (29.27) | |
| Disease status | ||
| Benign | 188 (65.51) | |
| Cancer | 99 (34.49) |
Patient’s characteristics compared in groups with and without prostate cancer
The mean age, PSA, and PSAD were significantly higher in patients with prostate cancer compared to those with benign conditions. However, there was no significant difference in prostate volume and the severity of LUTS between the two groups (Table 3).
Table 3.
Patient characteristics in groups with and without prostate cancer (N = 287)
| Variables | Histopathology results | P-value | |
|---|---|---|---|
| Benign | Cancer | ||
| Number (%) | 188 (65.5) | 99 (34.5) | |
| Age (years) | |||
| Mean (SD) | 70.1 (10.1) | 73.0 (9.97) | < 0.001 |
| Age groups (in years) | |||
| 40–49 | 3 (1.5%) | 1 (1.0%) | |
| 50–59 | 24 (12.8%) | 4 (4.0%) | |
| 60–69 | 69 (36.5%) | 30 (30.3%) | |
| ≥ 70 | 92 (48.9%) | 64 (64.4%) | |
| IPSS for LUTS | |||
| Moderate LUTS | 8 (4%) | 9 (10%) | |
| Severe LUTS | 180 (96%) | 90 (90%) | 0.099 |
| Type of biopsy | |||
| Prostatectomy | 2 (0.1%) | 0 (0%) | |
| TURP | 164 (87.2%) | 37 (37.4%) | |
| Core | 22 (11.7%) | 62 (62.6%) | < 0.001 |
| PSA | |||
| Median (IQR) | 6.8 (2.4–13.8) | 42.9 (19–224.6) | < 0.0001 |
| Prostate volume | |||
| Median (IQR) | 68 (48.5–107) | 62 (46–91) | 0.2313 |
| PSAD | |||
| Median (IQR) | 0.08 (0.04–0.16) | 0.45 (0.26–3.34) | < 0.0001 |
Median (IQR) Mann- Whitney U test, Mean was compared using Students t – test and Proportions were compared using Pearson chi square test
Distribution of histopathological parameters in prostate cancer
Among 99 study participants with prostate cancer, 46 (46.5%) had a Gleason grade group 5. Perineural invasion was seen in 33 (33.3%) of the cases, and the majority, 24 (72.73%) of them were in Gleason grade group 5(Table 4).
Table 4.
Distribution of perineural invasion per grade group (N = 99)
| Gleason grade group | Total | ||||||
|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | |||
| Perineural invasion | No |
2 (3.0%) |
6 (9.1%) |
9 (13.6%) |
27 (41.0%) |
22 (33.3) |
66 (100%) |
| Yes |
0 (0%) |
0 (0%) |
1 (3.03%) |
8 (24.24%) |
24 (72.73%) |
33 (100%) | |
| Total |
2 (2.0%) |
6 (6.0%) |
10 (10.0%) | 35 (35.5%) | 46 (46.5%) | 99 (100%) | |
p 0.004. Fisher’s exact was used to compare the proportions and association
Determination of PSA and PSAD cutoff for predicting prostate cancer
The ROC curves for PSAD and prostate-specific antigen (PSA) are shown in Fig. 3. The AUC for PSAD was 0.9094 (95% CI: 0.8761–0.9426) and the optimal PSAD cutoff value for predicting prostate cancer was 0.23ng/ml2. The AUC for prostate-specific antigen was 0.8932 (95% CI: 0.8569–0.9295), and the optimal cutoff value for predicting prostate cancer was 15ng/ml (Fig. 1).
Fig. 3.
Scatter plot showing the relationship between prostate Gleason grade groups and PSA
Fig. 1.
Receiver operating characteristics (ROC) curve and Area under the curve (AUC) to determine cutoff values for prostate specific antigen density (PSAD) and prostate specific antigen (SPSA)
The sensitivity and specificity of PSAD and PSA for predicting prostate cancer
Table 5 below highlights the comparative utility of different levels of PSA and PSAD in predicting prostate cancer. Using a normal recommended PSA value of PSA (0–4.0), the sensitivity, specificity, PPV, NPV, and accuracy were 99%, 36.7%, 45.2%, 98.6%, and 58.2% respectively. Using this as an indication for the biopsy, a total of 69/287 (24.0%) cases were unnecessary biopsies.
Table 5.
Sensitivity and Specificity of PSAD and PSA compared to Histopathological diagnosis of prostate biopsy
| Parameters | Histopathology diagnosis prostate cancer | Sensitivity | Specificity | PPV | NPV | |||
|---|---|---|---|---|---|---|---|---|
| Positive | Negative | Total | ||||||
| PSAD (ng/ml2) | > 0.23 | 86 | 33 | 119 | 86/99 = 86.9% | 155/188 = 82.4% | 86/119 = 72.2% | 155/168 = 92.3% |
| ≤ 0.23 | 13 | 155 | 168 | |||||
| Total | 99 | 188 | 287 | |||||
| PSA | > 4 | 98 | 119 | 217 | 98/99 = 99.0% | 69/188 = 36.7% | 98/216 = 45.2% | 69/70 = 98.6% |
| ≤ 4 | 1 | 69 | 70 | |||||
| Total | 99 | 188 | 287 | |||||
| PSA | > 15 | 83 | 41 | 124 | 83/99 = 83.8% | 147/188 = 78.2% | 83/124 = 66.9% | 147/163 = 90.2% |
| ≤ 15 | 16 | 147 | 163 | |||||
| Total | 99 | 188 | 287 | |||||
| PSA >4ng/ml and PSAD > 0.23ng/ml2 | Yes | 86 | 32 | 118 | 86/99 = 86.9% | 156/188 = 83.0% | 86/118 = 72.9% | 156/169 = 92.3% |
| No | 13 | 156 | 169 | |||||
| Total | 99 | 188 | 287 | |||||
Using the PSAD of 0.23ng/ml2, it has a sensitivity, specificity, PPV, NPV, and accuracy of 86.9%, 82.4%, 72.2%, 92.3% and 84.0% respectively. Using this as an indication for biopsy, this would have prevented 155/287 (54.0%) unnecessary biopsies compared to the use of normal PSA alone. Using an optimal cutoff determined at 15ng/ml of PSA, the sensitivity, specificity, PPV, NPV, and accuracy were 83.8%, 78.2%, 66.9%, 90.2%, and 80.1% respectively. Using this as an indication for biopsy, this would have prevented 147/287 (51.2%) unnecessary biopsies compared to the use of normal PSA. Combined both PSAD of > 0.23ng/ml2 and PSA of > 4ng/ml yielded a Sensitivity, Specificity, PPV, NPV, and Accuracy of 87.7%, 74.6%, 74.1%, 12.0%, and 84.3%. If the decision for biopsy is based on these combined tests, this would prevent 156/287 (54.4%) unnecessary biopsies. The concordant and discordant cases have been represented in Fig. 2.
Fig. 2.
Concordance and discordances between PSA and PSAD: (A) In this BPH, the PSA was above the cut-off value (29.4ng/ml) and PSAD was below the cut-off value (0.199ng/ml2), (B) In this Gleason pattern 4, PSA was below the cut-off value(2.6ng/ml) and PSAD was above the cut-off value(0.056ng/ml2),(C) Is the mixture of Gleason pattern 4 and 5, both PSA and PSAD were above the cut-off values (PSA=10ng/ml and PSAD 0.042ng/ml2),(D)Comedo necrosis Gleason score 5, both PSA and PSAD were above the cut-off value (57ng/ml and 0.263ng/ml2)
Correlation between the Gleason grade groups and PSAD
The results in Table 6 show, there was an increase in median PSA (from 8.15 to 64) and PSAD (from 0.09 to 1.21) from Gleason grade 1 towards grade 4. However, Gleason grade 5 had a slightly lower median value for both PSA and PSAD.
Table 6.
The median PSA and PSAD broke down into respective Gleason grade groups of prostate cancer
| Gleason grade groups | |||||
|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | |
|
PSA ng/ml Median (IQR) |
8.15 (4.8–11.5) |
18.94 (12.2–32) |
35 (20.4–42.9) |
64 (17–176) |
62 (25–400) |
|
PSAD ng/ml2 Median (IQR) |
0.09 (0.06–0.14) |
0.22 (0.18–0.29) |
0.42 (0.34–0.54) |
1.21 (0.29–3.57) |
0.67 (0.27–9.09) |
Further analysis using the correlation curve in Fig. 3 with Spearman’s rank correlation shows there was a weak positive correlation between increasing PSAD with Gleason grade group with the Spearman’s rho (ρ) of 0.2456 and p-value of 0.0143 which was statistically significant (Fig. 3).
Discussion
In this study, we aimed to assess the role of PSAD in the detection of prostate cancer and its correlation with the Gleason grade groups in patients with prostate-related urinary symptoms at a tertiary facility in Tanzania. The findings demonstrated that PSAD has potential utility in the assessment of prostate cancer and in differentiating between prostate cancer and benign prostate hyperplasia, especially in men presenting with prostate-related urinary symptoms.
The existing controversies on using serum PSA levels to decide on prostate biopsy due to low sensitivity could be solved by the use of PSAD [13, 17], which has proved to improve diagnostic accuracy when incorporated into the diagnostic algorithm despite its variations with geographical locations [14, 19, 22]. This study showed that the optimal cutoff of PSAD 0.23ng/ml2 better predicts prostate cancer with high sensitivity and specificity. The optimal cut-off PSAD seen in this study is similar to that of Kenya, which showed a cut-off of 0.23ng/ml2 [23]. However, this is higher than that seen in South Africa and Nigeria, which were 0.1 and 0.04ng/ml2, respectively [17, 24], and are less than that of Indonesia which was 0.4113ng/ml2 [25]. These variations support the known fact that PSAD is variable in different geographical locations [14, 19]. This study found that if PSAD is incorporated in clinical decision for tissue biopsy, the prostate biopsy would decrease by 86/287 (27.0%) at BMC.
Although, there was a correlation between the increase in PSAD with Gleason grade, by the increment in median PSAD (from 0.09 to 1.21) from Gleason grade group 1 to group 4. However there PSAD was observed to decrease in grade group 5 which is a similar trend reported by Maher et al. and Lotfi et al. [17, 26]. This trend can be attributed to the fact that, in some high-grade lesions there is the tendency of cells to dedifferentiate and impaired ability to produce measurable PSA which is the parameter for determining the PSAD [27].
The study limitations include: First, findings from this study can be generalized to patients with prostate-related urinary symptoms; however, the determined PSAD optimal value cannot be generalized to the general population. Second, prostate volume was measured by Transabdominal ultrasound, whereas MRI is more accurate. So, the prostate volume could be different if MRI were used; however, this is an expensive approach. Inflammatory conditions that elevate PSA levels may introduce a potential bias in this study.
Conclusions
The current study has established that PSAD plays a significant role in distinguishing benign and malignant prostate conditions and can be a useful predictor of prostate cancer aggressiveness. The correlation between PSAD and Gleason grade groups found in this study suggests that higher PSAD is associated with more aggressive cancer up to Grade group 4 cancers only. This makes PSAD a valuable tool in guiding biopsy decisions, risk stratification, and treatment planning in patients with prostate-related urinary symptoms.
The use of PSA for screening prostate cancer has high sensitivity but low specificity, which may lead to a significant number of unnecessary biopsies. In correlation with clinical presentation, the PSAD of 0.23ng/ml2 gives a reasonable sensitivity and specificity in the prediction of prostate cancer for patients at Bugando Medical Centre.
Supplementary Information
Acknowledgements
None.
Abbreviations
- AUC
Area under the curve
- BMC
Bugando Medical Center
- BPH
Benign prostate hyperplasia
- CREC
CUHAS/BMC joint ethical review committee
- DRE
Digital rectal examination
- FG
French gauge
- IPSS
International Prostate Symptom Score
- LUTS
Lower urinary tract symptoms
- MRI
Magnetic resonance image
- NPV
Negative predictive value
- PPV
Positive predictive value
- PSAD
Prostate specific antigen density
- PSA
Prostate-specific antigen
- ROC
Receiver operating characteristic curve
- STATA
Statistical software for data science
- TURP
TURP-Transurethral resection of prostate
Authors’ contributions
NJ, JI, and EE concept design acquisition of data, analysis, and interpretation, and manuscript draft, BK data analysis and review of the manuscript, PR, JK, CM, SM, AM, OO, and SI critical review of the manuscript. All authors approved the final version of the manuscript.
Funding
No funds were received.
Data availability
The dataset used during the current study is available from the corresponding author on reasonable request.
Declarations
Ethics approval and consent to participate
Ethical clearance was given by the joint CUHAS/BMC Research Ethics and Review Committee before the commencement of the study, with clearance certificate number CREC/718/2023. Informed consent to participate in this study was obtained from each participant.The study adhered to the Declaration of Helsinki.
Consent for publication
The study protocol was approved by the Joint CUHAS/BMC Research Ethics and Review Committee, and publication consent for research findings and related images was obtained from each participant.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The dataset used during the current study is available from the corresponding author on reasonable request.