Evaluating the Correlation between Serum Prostate-specific antigen Values and Gleason Score of the Prostate Carcinoma with Gallium 68- Prostate-specific membrane antigen Uptake in the Prostate Tumor in Primary Staging

doi:10.21203/rs.3.rs-3397873/v1

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Research Article

Evaluating the Correlation between Serum Prostate-specific antigen Values and Gleason Score of the Prostate Carcinoma with Gallium 68- Prostate-specific membrane antigen Uptake in the Prostate Tumor in Primary Staging

https://doi.org/10.21203/rs.3.rs-3397873/v1

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Objective

Gallium-68 - prostate-specific membrane antigen (Ga68-PSMA) PET/CT plays a crucial role in staging, evaluating treatment, and diagnosing local recurrence of prostate tumors. The National Comprehensive Cancer Network ( NCCN) guidelines have recently recommended it as the preferred staging method for unfavorable intermediate and high-risk patients. This study aims to evaluate the correlation between serum prostate-specific antigen (PSA) levels and the Gleason score of prostate tumors with the findings of Ga 68-PSMA PET/CT scans in primary staging.

Methods

In this cross-sectional study, newly diagnosed prostate cancer patients referred for Ga68-PSMA PET/CT whole-body scans were enrolled. The scans were performed at three-time points (early, whole-body, and late). The standardized uptake value of Ga68-PSMA in the primary tumor and its association with serum PSA levels, tumor Gleason score, and presence of tumor metastasis were evaluated and analyzed.

Results

Forty-nine male patients, 65 years old on average (interquartile range (IQR): 59–69) were included in the study. Of these patients, 43.9% were classified as high-risk based on their Gleason score (8–10). The median serum PSA level was 17 ng/mL (IQR: 8.02–42.10). PSA levels correlated with the maximum standardized uptake value (SUVmax) of the tumor in the whole-body stage of the scan (p < 0.05; r = + 0.392) but not in the early or late stages (p > 0.05). Gleason scores positively correlated with tumor SUVmax in all three scan stages (p < 0.05).

Conclusions

Our results indicate that the Gleason score significantly correlates with the SUVmax of the prostate tumor in all three-time points of the scan. However, serum PSA levels only correlate with the tumor SUVmax in the whole-body stage of the scan, not in the early and late stages. In the whole-body stage, a higher SUVmax is significantly associated with higher Gleason scores, bladder wall, invasion of the seminal vesicle, and lymph node metastasis (p < 0.05).

Prostate cancer

tumor staging

Ga68-PSMA PET/CT scan

PSA

Gleason score

One of the most prevalent cancers and a major contributor to cancer-related mortality is prostate cancer among men worldwide (1). The prevalence of prostate cancer has been rising from 2014 through 2019, by 3% every year, after twenty years of reduction. This increase translates to an additional 99,000 new cases of prostate cancer in recent years (2). The diagnosis and staging of prostate tumors are crucial for determining suitable treatment strategies and predicting patient outcomes. The Gleason score obtained from transrectal biopsies has historically been the gold standard for assessing tumor aggressiveness. It involves a microscopic examination of cancer cells in a biopsy sample, with scores ranging from 2 to 10. Higher Gleason scores indicate more aggressive prostate cancers. Additionally, levels of prostate-specific antigen (PSA), pro-PSA, and its reflection in the prostate health index (PHI) are used to predict tumor behavior (3, 4).

In recent years, gallium-68 - prostate-specific membrane antigen (Ga68-PSMA) PET/CT imaging has gained significant attention for staging and evaluating treatment response in prostate tumors, particularly in cases of cancer recurrence (5).

PSMA is often overexpressed in prostate cancer cells, making it an effective target for tumor-specific imaging techniques that use radiolabeled molecules binding with PSMA (6). Ga68-PSMA PET/CT imaging has shown high sensitivity and specificity, potentially enabling earlier disease detection. However, there needs to be more high-quality data regarding its use for primary staging (6, 7).

In this study, we aimed to investigate the role of Ga68-PSMA PET/CT scans in the primary staging of prostate cancers and the relationship between scan findings, serum PSA levels, and Gleason score of the prostate tumor.

Study Design

We conducted a cross-sectional study to investigate the association between PSA levels and Gleason score of primary prostate tumors with the uptake of Ga68-PMSA (at three-time points) in the primary tumors and metastatic sites of prostate cancer patients during primary staging.

Participants

All males with a definitive diagnosis of prostate cancer (either through biopsy or high clinical suspicion following a significant increase in serum PSA levels, i.e., more than 50 ng/dl) who were referred to the nuclear medicine ward of Razavi Hospital, Mashhad, Iran for Ga68-PSMA PET/CT whole-body scans from March 21, 2021 until March 21, 2022 were enrolled. All patients were treatment-naive at the time of evaluation. Patients who had undergone pelvic irradiation were excluded.

Data Collection

Demographic data, such as the patient's age, Gleason scores, and the latest serum PSA levels, were recorded. Patients were stratified based on their Gleason score into four risk groups: low risk (score = < 6), intermediate risk (score 7), and high risk (score 8–10), according to the latest version of the National Comprehensive Cancer Network (NCCN) guideline.

Procedure

The patients underwent a Ga68-PMSA PET/CT scan for tumor staging. The imaging included initial static images taken about 3 minutes post-injection from the pelvic area, routine whole-body imaging about one-hour post-injection, and delayed imaging from the patient's pelvic region about 3 hours post-injection. Scan findings were recorded, and the prostate tumor's maximum standardized uptake value (SUVmax) at each stage was evaluated.

Statistical Analysis

The statistical software SPSS(version 20) was applied for the analysis. Demographic data and general patient characteristics were presented using descriptive statistical methods, including central tendency, measures of dispersion, and frequency distribution percentages. The relationship between various qualitative variables was assessed using chi-square and Fisher's exact tests. To compare quantitative variables between two groups with a normal distribution and equal variances, the independent t-test was used. Conversely, the Mann-Whitney test was performed for variables with non-normal distribution. One-way ANOVA or Kruskal-Wallis tests were utilized to compare quantitative variables across more than two groups. Finally, Pearson or Spearman correlation tests assessed the correlation between different quantitative variables. A p-value of less than 0.05 was considered statistically significant.

Ethical consideration

The study was approved by the ethics committee of Mashhad University of Medical Sciences (ethics code of IR. MUMS.MEDICAL.REC.1401.034).

General Characteristics: A total of 49 male patients with a median age of 65 years (interquartile range (IQR): 59–69) were enrolled. Forty-one patients (83.7%) had prostate cancer confirmed by biopsy, while eight others were referred for imaging due to a recently elevated serum PSA level (i.e., more than 50 ng/dl). Among the patients who underwent a biopsy, 51.2% were in the intermediate-risk group (Gleason scores of 7). The median time to early, whole-body, and late stages of the scan after the administration of Gallium-68 were 17 minutes (IQR: 8.02–42.10), 61 minutes (IQR: 57–65), and 169 minutes (IQR: 157–181), respectively (Table 1). The results of the Spearman correlation test showed no significant relationship between age, serum PSA levels, and Gleason score (p > 0.05).

Table 1

The demographic and general characteristics of included patients
Variables				Median (IQR) or N (%)^*
Age (years)				65 (59–69)
Latest PSA (ng/mL)				17 (8.02–42.10)
Gleason score				8 (7–9)
	Moderate risk (4–6)		2 + 3	1 (2.4%)	2 (4.9%)
	Moderate risk (4–6)		3 + 3	1 (2.4%)	2 (4.9%)
	Intermediate risk (7–8)		3 + 4	8 (19.5%)	21 (51.2%)
			4 + 3	6 (14.6%)
			3 + 5	2 (4.9%)
			4 + 4	5 (12.2%)
	High risk (9–10)		4 + 5	11 (26.8%)	18 (43.9%)
			5 + 4	6 (14.6%)
			5 + 5	1 (2.4%)
Total				41 (100%)
Administrated dose of Ga68-PSMA (mCi)				4 (2-5.5)
Time after injection (m)
		Early stage		17 (8.02–42.10)
		Whole-body stage		61 (57–65)
		Late stage		169 (157–181)
SUVmax of the tumor
		Early stage		5.12 (3.89–10.21)
		Whole-body stage		8.22 (4.55–19.43)
		Late stage		11.69 (5.53–26.09)
^* The median was used to express the continuous variables (IQR). The qualitative data were described as the frequency (%)

Gallium-68 PSMA scan findings

As shown in Table 2, the Gallium-68 PSMA PET/CT scan confirmed prostate cancer in all patients. Lymph node and bone metastasis were seen in 44.9% and 28.6% of patients, respectively. The lymph node metastases that were most frequently found were the right and left external iliac lymph nodes (each detected in 20.4% of patients). The most common bones with metastasis were the right iliac, right pubis, and right ischium (6.1% each).

Table 2

Frequency of various findings on Ga-68-PSMA-PET/CT scan
Scan findings		N (%)
Prostate tumor		49 (100%)
Seminal vesicle invasion		10 (20.4%)
Bladder wall invasion		6 (12.2%)
Lymph node metastasis		22 (44.9%)
	Right external iliac	10 (20.4%)
	Left external iliac	10 (20.4%)
	Right internal iliac	7 (14.2%)
	Left internal iliac	6 (12.2%)
	Right obturator	6 (12.2%)
	Left obturator	5 (10.2%)
	Right presacral	4 (8.2%)
	Left common iliac	3 (6.1%)
	Left perirectal	3 (6.1%)
	Left presacral	2 (4.1%)
	Right inguinal	2 (4.1%)
	Right femoral	1 (2%)
Bone metastasis		14 (28.6%)
	Right iliac	3 (6.1%)
	Right pubis	3 (6.1%)
	Right ischium	3 (6.1%)
	Left pubis	2 (4.1%)
	Left ischium	2 (4.1%)
	Right sacrum	2 (4.1%)
	Left sacrum	2 (4.1%)
	Left acetabulum	2 (4.1%)
	Left iliac	1 (2%)
	Right femur	1 (2%)
	Left femur	1 (2%)

Correlation between Gallium-68 PSMA scan findings and other characteristics

Lymph node metastasis (p = 0.011) and seminal vesicle invasion (p = 0.035) were significantly more common among patients with high-risk tumors (Gleason scores of 8–10) than among patients with intermediate-risk tumors (Gleason scores of 7). However, no significant differences were seen in bladder wall invasion and bone metastasis (p > 0.05). Patients with lymph node and bone metastases also had considerably higher serum PSA values (p = 0.002 and p = 0.038, respectively), but they did not relate to bladder wall or seminal vesicle invasion (p > 0.05). These findings are summarized in Table 3.

Table 3

The relationship between findings of Ga-68-PSMA-PET/CT scan and patients’ characteristics
Median (IQR) ^* or N (%)		Seminal Vesicle invasion	Bladder wall invasion	Lymph Node metastasis	Bone metastasis
Gleason score	Intermediate risk (7–8)	1 (4.8%)	1 (4.8%)	5 (23.8%)	4 (19%)
	High risk (9–10)	6 (33.3%)	2 (11.1%)	12 (66.7%)	8 (44.4%)
	P value	0.035	0.586	0.011	0.087
Age (years)	No invasion/metastasis	66 (59–69)	66 (59-69.5)	66 (59–69)	67 (59.5–69.5)
	With invasion/metastasis	64 (60.75–73.25)	62 (59.5–69.5)	64 (60.75-71)	62 (58-69.5)
	P value	0.385	0.677	0.450	0.474
PSA (ng/mL)	No invasion/metastasis	17 (7.89-39)	16.13 (7.89-39)	9.58 (6.14–22.67)	11.71(7.74–38.75)
	With invasion/metastasis	20.95 (8.88–61.91)	51 (9.23–90.70)	35.4(14.60–1.66)	34.5(14.88–74.25)
	P value	0.369	0.101	0.002	0.038
^* The continuous variables were presented as the median (IQR)

Association between Gallium-68 PSMA uptake and other characteristics

The age of the patients was not significantly associated with the SUVmax of the tumor at any of the scan time points (p > 0.05). However, there was a significant positive correlation between the tumor Gleason score and the SUVmax of the tumor in all scan stages (p < 0.05). Additionally, serum PSA levels showed a significant positive association with tumor SUVmax in the whole-body stage (p = 0.006, r = + 0.392) but not in the early or late stages of the scan (p > 0.05). These results are demonstrated in Table 4.

Table 4

Correlation between the SUVmax of the prostate tumor with patients’ characteristics
Tumor SUVmax		Age (years)	Gleason score	PSA (ng/mL)
Early stage	Correlation coefficient (r)	+ 0.118	+ 0.410	+ 0.154
Early stage	P value	0.512	0.034	0.400
Whole-body stage	Correlation coefficient (r)	+ 0.248	+ 0.460	+ 0.392
Whole-body stage	P value	0.086	0.003	0.006
Late stage	Correlation coefficient (r)	+ 0.211	+ 0.479	+ 0.291
Late stage	P value	0.281	0.024	0.133

The association between the median SUVmax of the tumor and other tumor characteristics was also assessed (Table 5). In the early scan stage, SUVmax was significantly higher in patients with bladder wall invasion and lymph node metastasis (p < 0.05). In the whole-body stage, higher SUVmax was significantly associated with higher Gleason scores (9–10 vs. 7–8), bladder wall and seminal vesicle invasion, and lymph node metastasis (p < 0.05 in all cases) but not with bone metastasis (p = 0.163). Finally, in the late stage of the scan, SUVmax of the tumor was significantly higher in patients with lymph node and bone metastasis (p < 0.05).

Table 5

Association between the SUVmax of the prostate tumor, risk group, and tumor metastasis/invasion
Variables	Maximum tumor standardized uptake values, Median (IQR)¹
Variables	Early scan	P value	Whole body scan	P value	Late scan	P value
Intermediate risk² (7–8)	5.87 ± 1.75	0.151	10.83 ± 7.84	0.007	16.84 ± 8.66	0.088
High risk² (9–10)	9.89 ± 5.40	0.151	20.87 ± 12.41	0.007	25.36 ± 13.99	0.088
No seminal vesicles invasion	7.84 ± 4.81	0.415	14.28 ± 11.54	0.018	19.07 ± 10.77	0.411
Seminal vesicles invasion	9.96 ± 4.64	0.415	28.02 ± 22.79	0.018	23.88 ± 16.23	0.411
No bladder wall invasion	7.63 ± 4.72	0.024	15.11 ± 11.98	0.026	19.62 ± 12.73	0.194
Bladder wall invasion	13.07 ± 1.41	0.024	31.25 ± 27.71	0.026	25.70 ± 3.96	0.194
No lymph nodes metastasis	6.19 ± 2.79	0.040	11.17 ± 8.45	0.001	15.16 ± 9.38	0.003
Lymph nodes metastasis	10.52 ± 5.50	0.040	24.34 ± 18.62	0.001	27.09 ± 12.52	0.003
No bone metastasis	7.28 ± 3.42	0.264	15.82 ± 15.84	0.163	18.21 ± 12.33	0.038
Bone metastasis	10.61 ± 6.66	0.264	20.26 ± 13.89	0.163	27.85 ± 8.83	0.038
¹The continuous variables were presented as the median (IQR)
²According to Gleason score

This study aimed to evaluate the diagnostic value of Ga68-PMSA PET/CT scan in primary staging of prostate tumors. Our results indicated that the Gleason score significantly correlated with SUVmax of prostate tumors in all three stages of the scan; however, serum PSA levels correlated with tumor SUVmax only in the whole-body stage of the scan, not in the early or late stages.

The utility of Ga68-PMSA PET/CT scan for primary staging of intermediate and high-risk prostate cancers and detecting tumor metastasis has been demonstrated in several studies (8–10).

Keidar et al. (11) described the patterns and frequency of metastatic sites of prostate cancer in 438 patients who underwent Ga68-PSMA PET/CT for staging or follow-up. They found abdominopelvic node involvement (29%) and bone metastases (25%) were common findings in PSMA scans. Similarly, our results showed that lymph node and bone metastasis were relatively frequent among intermediate and high-risk patients referred for primary staging by Ga68-PSMA PET/CT scan.

In a prospective multicenter study on 302 male patients with biopsy-proven prostate tumors and high-risk features, Hofman et al. (6) compared the accuracy of conventional CT and bone scans with Ga68-PMSA PET/CT. The results indicated that PMSA PET/CT had better sensitivity and specificity in detecting metastasis. Other studies have also shown similar results and concluded that Ga68-PMSA PET/CT scan has the potential to replace or complement other imaging techniques in this field (10, 12–15).

A recent systematic review and meta-analysis of twenty-seven studies, including a total of 2832 patients, demonstrated that PMSA PET/CT scan had a high negative predictive value in primary staging of lymph node metastasis and could decrease the number of unnecessary pelvic lymph node dissections, but only in low-risk patients (16).

Despite these promising findings, there is limited high-quality data on using Ga68-PMSA PET/CT scan in primary staging of prostate tumors and its correlation with Gleason score and PSA levels. Moreover, few studies have investigated the results of the Ga68-PMSA scan in all three stages. Schmidkonz et al. (17) demonstrated that SUVmax and SUV-mean of bone metastases from prostate tumors in Ga68-PMSA PET/CT were significantly higher in patients with Gleason scores > 7. Various parameters of the scan also correlated with changes in serum PSA levels (17). Similarly, we found that Gleason and serum PSA levels were positively associated with the SUVmax of the prostate tumor in the whole-body stage of the scan.

In another study by Kubilay et al., 77 cases of prostate cancer who underwent Ga-68-PSMA-PET/CT for primary staging were evaluated. It was shown that the SUVmax of the prostate tumor was significantly higher in patients with higher ISUP (International Society of Urological Pathology) grades. Moreover, metabolic tumor volume values were considerably higher in cases with histopathologically proven lymph node metastasis (18).

Similarly, Klingenberg et al. assessed 691 cases of newly biopsy-proven high-risk prostate cancer and reported that tumor SUVmax had a significant, albeit weak, correlation with cancer ISUP grade. The authors also concluded that the Ga-68-PSMA-PET/CT scan had high specificity and accuracy for detecting lymph node metastasis (96.5% and 84.5%, respectively), but its sensitivity was relatively low (30.6%) (19). Two recent retrospective studies and a literature review reached the same conclusion regarding the utility of Ga-68-PSMA-PET/CT scan in detecting lymph node metastases of prostate tumors (20–22).

The current study is among the few studies conducted on the role of Ga-68-PSMA-PET/CT scan in the primary staging of prostate tumors. Also, one of the first studies to evaluate Ga-68-PSMA uptake not only in the whole-body stage of the scan but also in the early and late stages. However, our work had several limitations. We only evaluated the role of Ga-68-PSMA-PET/CT scan in primary staging. Thus, caution should be practiced in generalizing the findings.

In summary, our study provides valuable insight into the utility of Ga-68-PSMA-PET/CT scan in the primary staging of prostate tumors and the relationship between scan findings and other patients' characteristics.

Ethical standards statement

Every procedure followed the guidelines of the Helsinki Declaration of 1975, as amended in 2008, and the national and institutional relevant committees on human experimentation's ethical standards. Each patient provided their informed consent to be included in the study.

Funding:The study was funded by a research grant from Mashhad University of Medical Sciences (grant number 4001054).

Conflict of interest: No potential conflicts of interest were disclosed.

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Evaluating the Correlation between Serum Prostate-specific antigen Values and Gleason Score of the Prostate Carcinoma with Gallium 68- Prostate-specific membrane antigen Uptake in the Prostate Tumor in Primary Staging

Status:

Version 1

Abstract

Objective

Methods

Results

Conclusions

Introduction

Materials and Methods

Study Design

Participants

Data Collection

Procedure

Statistical Analysis

Ethical consideration

Results

Gallium-68 PSMA scan findings

Correlation between Gallium-68 PSMA scan findings and other characteristics

Association between Gallium-68 PSMA uptake and other characteristics

Discussion

Conclusion

Declarations

References

Status:

Version 1