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Annals of Medicine and Medical Sciences
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  2. Vol. 05, No. 08, (2026)
  3. Clinical Response and Safety of Goserelin-Based Androgen Deprivation T…
Original Article Open Access

Clinical Response and Safety of Goserelin-Based Androgen Deprivation Therapy in Sudanese Patients with Prostate Cancer: A Retrospective Cohort Study

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Annals of Medicine and Medical SciencesVol. 05, No. 08, (2026) August 3, 2026pp. 1110 - 1116
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Abstract

Background: Prostate cancer is a leading malignancy among men worldwide, yet real-world treatment outcome data from low-resource oncology settings remain limited. Goserelin-based androgen deprivation therapy is widely used in Sudan, but its biochemical response and safety profile in routine Sudanese oncology practice are poorly documented. Objectives: To assess prostate-specific antigen (PSA) response, PSA velocity, biochemical recurrence, and documented adverse events among Sudanese prostate cancer patients. Design: A retrospective cohort study. Methods: The medical records of prostate cancer patients treated with goserelin-based therapy at Khartoum Oncology Teaching Hospital, Sudan, between March 2018 and March 2020 were reviewed. Eligible patients were classified into three groups: localized prostate cancer treated with goserelin plus bicalutamide; metastatic prostate cancer treated with goserelin plus bicalutamide; and metastatic prostate cancer treated with goserelin plus bicalutamide and radiotherapy. Outcomes included PSA change, PSA velocity, biochemical recurrence, and documented adverse events. Non-parametric statistical tests were used, with significance set at p<0.05. Results: The study included 68 men with a mean age of 70.1±5.4 years. Patients with localized disease achieved marked PSA suppression, with median PSA decreasing from 100.0 ng/mL to 0.10 ng/mL (p<0.001) and biochemical recurrence occurring in 20.0%. In contrast, metastatic patients treated with goserelin plus bicalutamide showed no significant PSA reduction (490.0 to 100.0 ng/mL; p=0.813), with biochemical recurrence in 85.7%. Metastatic patients receiving additional radiotherapy also showed non-significant PSA reduction (100.0 to 37.85 ng/mL; p=0.432), with biochemical recurrence in 87.5%. Biochemical recurrence was significantly lower in localized disease than in both metastatic groups. Any adverse event occurred in 29.4% of patients. Conclusion: Goserelin-based therapy produced substantial biochemical control in localized prostate cancer but inadequate PSA control in metastatic disease. These findings support local treatment audits, improved follow-up, and access to contemporary systemic intensification strategies.

Keywords

Prostate cancer goserelin androgen deprivation therapy prostate-specific antigen biochemical recurrence Sudan.

1. Introduction

Prostate cancer remains a major global health burden and one of the most frequently diagnosed malignancies among men. Global cancer estimates indicate that prostate cancer accounted for approximately 7.3% of all new cancer diagnoses worldwide in 2022 and remains a major contributor to male cancer morbidity and mortality [1]. The burden is particularly consequential in low- and middle-income countries, where delayed diagnosis, limited access to radiotherapy, restricted availability of contemporary systemic agents, and incomplete longitudinal follow-up may widen the gap between efficacy observed in clinical trials and outcomes achieved in routine practice [2,3].

Androgen signalling is central to prostate cancer biology. Since the landmark demonstration that androgen suppression can induce clinical improvement in metastatic prostate cancer, androgen deprivation therapy (ADT) has remained a therapeutic backbone across several disease states [4,5]. Goserelin, a luteinizing hormone-releasing hormone agonist, suppresses testosterone after initial gonadotropin stimulation and pituitary downregulation. It is commonly combined with an antiandrogen, such as bicalutamide, to reduce the clinical consequences of testosterone flare during treatment initiation [4,6]. Randomized trials have established the benefit of goserelin-based ADT when combined with radiotherapy in localized and locally advanced prostate cancer, improving biochemical control, disease-free survival, and overall survival compared with radiotherapy alone [7-11]. Comparative evidence also supports goserelin as a medical castration alternative to orchiectomy, with broadly comparable testosterone suppression and clinical outcomes [12].

The therapeutic landscape has evolved substantially for metastatic hormone-sensitive prostate cancer. Contemporary guidelines increasingly emphasize treatment intensification beyond ADT alone, including docetaxel, abiraterone, androgen receptor pathway inhibitors, and selected radiotherapy to the primary tumour according to metastatic burden and patient fitness [4,13-16]. Recent real-world and phase III studies also show that newer sustained-release goserelin formulations retain biochemical efficacy and acceptable safety profiles, although these data mainly arise from Asian and high-resource clinical contexts [17-19]. Therefore, the clinical value of goserelin-based regimens in resource-limited African oncology practice remains insufficiently described.

In Sudan, goserelin represents an important therapeutic backbone for prostate cancer care, particularly at Khartoum Oncology Teaching Hospital, a major national oncology referral centre. However, there is limited published evidence on biochemical response, recurrence patterns, and tolerability among Sudanese patients receiving goserelin-based therapy. This evidence gap limits local treatment evaluation, guideline development, and identification of patients who may require intensified systemic therapy. Therefore, this study aimed to assess PSA response, PSA velocity, biochemical recurrence, and documented adverse events among prostate cancer patients treated with goserelin-based regimens at Khartoum Oncology Teaching Hospital

2. Methods

2.1. Study Design and Setting: This retrospective cohort study was conducted at Khartoum Oncology Teaching Hospital, Khartoum, Sudan. The study reviewed medical records of patients with prostate cancer treated between March 2018 and March 2020. This hospital provides comprehensive oncology services, including chemotherapy, radiotherapy, surgical oncology, and palliative care, to patients from across Sudan [20,21].

2.2. Study Population and Sampling: A total-coverage sampling strategy was used. All eligible patients with prostate cancer who received goserelin-based therapy during the study period and had complete, accessible medical records were included. Patients receiving 5-alpha-reductase inhibitors for benign prostatic hyperplasia were excluded because these agents may influence PSA levels and confound PSA-based treatment-response assessment. The final cohort included 68 patients.

2.3. Exposure groups: Patients were classified into three treatment groups according to metastatic status and concurrent therapy. Group A included patients with localized prostate cancer treated with goserelin plus bicalutamide. Group B included patients with metastatic prostate cancer treated with goserelin plus bicalutamide. Group C included patients with metastatic prostate cancer treated with goserelin plus bicalutamide and concurrent radiotherapy

2.4. Data Collection Tool and Variables: Data were extracted from medical records using a standardized data collection form. Extracted variables included age, marital status, residence, occupation, metastatic status, treatment group, serial PSA values, follow-up status, and documented adverse events. The final PSA value was defined as the last non-missing PSA measurement available in the medical record.

2.5. Outcomes: The primary biochemical outcomes were change in PSA from baseline to final recorded measurement, final recorded PSA, PSA velocity, and biochemical recurrence. Biochemical recurrence was defined in the dataset as final PSA >0.4 ng/mL, based on the clinical threshold used in the thesis source and previous biomarker literature [18]. PSA velocity was calculated as the change between final and baseline PSA over the recorded measurement interval; negative values indicated PSA reduction. Safety outcomes included adverse events documented in the medical records, including back pain, loss of libido, nocturia, and limb pain.

2.6. Statistical Analysis: Data were entered and coded using the Statistical Package for Social Sciences, version 26 (Armonk, NY: IBM Corp). Continuous variables were summarized as mean ± standard deviation when approximately normally distributed and as median with interquartile range when skewed. Categorical variables were summarized as frequencies and percentages. Because PSA variables were non-normally distributed, non-parametric tests were used. The Kruskal–Wallis test compared continuous outcomes across three groups, followed by Bonferroni-corrected pairwise comparisons when appropriate. The Mann–Whitney U test compared two independent groups. The Wilcoxon signed-rank test assessed within-group PSA change from baseline to final measurement. Fisher’s exact test assessed categorical associations where expected cell counts were small. Statistical significance was set at p<0.05.

2.7. Ethical Considerations: The study was carried out in compliance with the 1975 Declaration of Helsinki and was approved by the Ethical Committee of the Faculty of Pharmacy at the University of Khartoum (FPEC-52-2021). Due to the retrospective nature of the study and the use of anonymous data, informed consent was waived by the ethics committees. Strict confidentiality and anonymity of participants’ data were maintained throughout the research process.

3. Results

3.1. Baseline characteristics: The cohort included 68 men with prostate cancer. Group A included 45 patients with localized disease treated with goserelin plus bicalutamide. Group B included seven patients with metastatic disease treated with goserelin plus bicalutamide. Group C included 16 patients with metastatic disease treated with goserelin plus bicalutamide and radiotherapy. The mean age was 71.5±5.0 years in Group A, 69.1±6.2 years in Group B, and 66.6±5.1 years in Group C. All patients were married. Loss to follow-up occurred in 5/7 patients in Group B and 9/16 patients in Group C, while no loss to follow-up was recorded in Group A (Table 1).

Table 1 Baseline characteristics and treatment groups among prostate cancer patients receiving goserelin-based therapy
Variable Group A: localized, goserelin + bicalutamide (n=45) Group B: metastatic, goserelin + bicalutamide (n=7) Group C: metastatic, goserelin + bicalutamide + RT (n=16)
Age, mean±SD, years 71.5±5.0 69.1±6.2 66.6±5.1
Age, median [IQR], years 71.0 [68][75] 66.0 [65][75] 68.0 [63][71]
Localized disease 45 (100.0) 0 (0.0) 0 (0.0)
Metastatic disease 0 (0.0) 7 (100.0) 16 (100.0)
Lost to follow-up 0 (0.0) 5 (71.4) 9 (56.3)
Married 45 (100.0) 7 (100.0) 16 (100.0)

Abbreviations: RT: radiotherapy; SD: standard deviation; IQR: interquartile range.

3.2. PSA response and biochemical outcomes: Baseline PSA differed across groups, with the highest median baseline PSA in Group B. Final PSA values differed significantly across treatment groups (Kruskal–Wallis H=30.05, p<0.001). Group A had a markedly lower median final PSA than Group B (p=0.001) and Group C (p<0.001), while Groups B and C did not differ significantly (p=0.666) (Table 2). Within-group analysis showed a significant PSA reduction in Group A, from a median of 100.0 ng/mL to 0.10 ng/mL (p<0.001). PSA reductions were not statistically significant in Group B (490.0 to 100.0 ng/mL; p=0.813) or Group C (100.0 to 37.85 ng/mL; p=0.432) (Table 2).

Table 2 PSA outcomes according to treatment group
Outcome Group A (n=45) Group B (n=7) Group C (n=16) p-value
Baseline PSA, median [IQR], ng/mL 100.0 [100.0–174.0] 490.0 [200.0–600.0] 100.0 [100.0–100.0] —
Baseline PSA, min–max, ng/mL 51.0–600.0 60.9–938.0 57.1–200.0 —
Final PSA, median [IQR], ng/mL 0.10 [0.10–0.20] 100.00 [100.00–460.00] 37.85 [0.60–105.50] <0.001
Final PSA, min–max, ng/mL 0.00–120.00 0.10–1500.00 0.10–513.00 —
PSA velocity, median [IQR] −14.3 [−24.6 to −12.5] −40.0 [−81.9 to +87.8] −11.2 [−12.9 to +0.8] 0.002
Direction of PSA velocity PSA falling Mixed response Partial response —

Abbreviations: PSA: prostate-specific antigen. PSA velocity was reported in the thesis as ng/mL per quarter/recorded interval; the unit should be verified before submission. Final PSA comparison used Kruskal–Wallis test; post-hoc comparisons for final PSA: Group A vs Group B, p=0.001; Group A vs Group C, p<0.001; Group B vs Group C, p=0.666.

3.3. PSA velocity: PSA velocity differed significantly across treatment groups (Kruskal–Wallis H=12.25, p=0.002). Group A showed a median PSA velocity of −14.3 ng/mL per quarter/recorded interval, indicating sustained PSA decline. Group B had a mixed response pattern, while Group C showed partial biochemical response (Table 3). PSA velocity differed significantly between Group A and Group C (p=0.001), but not between Group A and Group B (p=0.901) or Group B and Group C (p=0.543). Localized patients showed significantly greater PSA reduction than metastatic patients (Mann–Whitney U=338.5, p=0.021). PSA velocity did not differ significantly by age group (p=0.082) (Table 3).

Table 3 Within-group PSA change from baseline to final recorded measurement
Treatment group Baseline PSA, median, ng/mL Final PSA, median, ng/mL p-value
Group A: localized, goserelin + bicalutamide 100.0 0.10 <0.001
Group B: metastatic, goserelin + bicalutamide 490.0 100.0 0.813
Group C: metastatic, goserelin + bicalutamide + RT 100.0 37.85 0.432

Abbreviations: RT: radiotherapy.

3.4. Biochemical recurrence: Biochemical recurrence occurred in 9/45 patients in Group A (20.0%), 6/7 patients in Group B (85.7%), and 14/16 patients in Group C (87.5%). Compared with Group A, recurrence was significantly higher in Group B (p=0.001) and Group C (p<0.001). Recurrence did not differ significantly between Groups B and C (p=1.000) (Table 4).

Table 4 Biochemical recurrence according to treatment group
Group Biochemical recurrence, n BCR rate, % p-value versus Group A
Group A: localized, goserelin + bicalutamide 9 20.0 Reference
Group B: metastatic, goserelin + bicalutamide 6 85.7 0.001
Group C: metastatic, goserelin + bicalutamide + RT 14 87.5 <0.001
Group B vs Group C — — 1.000

Abbreviations: BCR: biochemical recurrence, defined as final PSA >0.4 ng/mL. Fisher’s exact test was used.

3.5. Adverse events: Any documented adverse event occurred in 20/68 patients (29.4%). Back pain occurred in 9 patients (13.2%) and was significantly associated with Group C (p<0.001). Loss of libido occurred in eight patients (11.8%) and did not differ significantly across groups (p=0.145). Nocturia occurred in three patients (4.4%) and was significantly associated with Group B (p=0.004). Limb pain occurred in one patient (1.5%) and was not significantly associated with treatment group (p=0.192) (Table 5).

Table 5 Documented adverse events according to treatment group
Adverse event Group A (n=45) Group B (n=7) Group C (n=16) Total (N=68) Fisher’s exact p-value*
Back pain 0 (0.0) 0 (0.0) 9 (56.3) 9 (13.2) <0.001
Loss of libido 3 (6.7) 1 (14.3) 4 (25.0) 8 (11.8) 0.145
Nocturia 1 (2.2) 2 (28.6) 0 (0.0) 3 (4.4) 0.004
Limb pain 0 (0.0) 0 (0.0) 1 (6.3) 1 (1.5) 0.192
Any adverse event 4 (8.9) 3 (42.9) 13 (81.3) 20 (29.4) <0.001

*Values are n (%). Fisher’s exact test was used because expected cell frequencies were small.

3.6. Exploratory associations: As shown in Table 6, localized patients were significantly older than metastatic patients, with median ages of 71.0 years and 67.0 years, respectively (p=0.004). Age was not significantly associated with final PSA overall (Spearman ρ=−0.096, p=0.438), and final PSA did not differ significantly across age quartiles (p=0.554). Occupation was not significantly associated with metastatic status (p=0.539) or final PSA (p=0.885). Residence was not significantly associated with metastatic status (p=0.123) (Table 6).

Table 6 Exploratory associations with metastatic status and PSA outcomes
Association tested Key result p-value
Age by metastasis status Localized patients were older than metastatic patients; median 71.0 vs 67.0 years 0.004
PSA velocity by metastasis status Localized patients had greater PSA reduction than metastatic patients 0.021
PSA velocity by age group No significant difference between age 50–70 and >70 years 0.082
Age versus final PSA No significant correlation; ρ=−0.096 0.438
Final PSA by age quartile No significant difference across age quartiles 0.554
Metastasis status by occupation No significant association 0.539
Final PSA by occupation No significant difference 0.885
Metastasis status by residence No significant association 0.123

4. Discussion

This retrospective cohort study provides real-world evidence on goserelin-based ADT among Sudanese patients with prostate cancer treated at a major national oncology referral centre. The main finding is clinically important: goserelin plus bicalutamide achieved substantial PSA suppression and a lower biochemical recurrence rate in localized prostate cancer, but metastatic disease showed poor biochemical control whether treated with goserelin plus bicalutamide alone or with added radiotherapy. Group A achieved a highly significant PSA reduction from 100.0 ng/mL to 0.10 ng/mL and had a biochemical recurrence rate of 20.0%. In contrast, biochemical recurrence exceeded 85% in both metastatic groups. Documented adverse events appeared tolerable overall, although back pain and nocturia differed significantly across treatment groups.

The favourable biochemical response observed in localized disease is consistent with landmark evidence supporting goserelin-based ADT in localized and locally advanced prostate cancer. Bolla et al. showed that adding goserelin to radiotherapy improved overall survival and disease-free survival in locally advanced disease [7]. Jones et al. similarly demonstrated improved survival and reduced disease-specific mortality with short-term ADT plus radiotherapy in localized prostate cancer [8]. Other randomized evidence supports carefully timed neoadjuvant and adjuvant androgen suppression as part of definitive treatment strategies [9,10], while pooled analyses suggest that adjuvant goserelin improves clinical disease-free survival and reduces disease-related mortality [11]. The strong PSA suppression in our localized cohort therefore aligns with the established biological and clinical efficacy of ADT in hormone-sensitive, non-metastatic disease.

The poor biochemical control observed in metastatic disease requires careful interpretation. ADT remains foundational in metastatic prostate cancer, but contemporary evidence no longer supports ADT alone as optimal treatment for most fit patients with metastatic hormone-sensitive disease. The CHAARTED and STAMPEDE platforms showed that adding docetaxel to ADT improves survival in metastatic hormone-sensitive prostate cancer [13,14]. Trials of abiraterone plus prednisone also showed significant survival and failure-free survival benefits when added to ADT [15]. Radiotherapy to the primary tumour may benefit selected patients with low metastatic burden, but it is not a substitute for systemic intensification in metastatic disease [16]. In this context, the high recurrence rates in Groups B and C may reflect advanced tumour biology, high baseline PSA, limited treatment intensification, incomplete staging, high loss to follow-up, or restricted access to contemporary agents.

The findings also emphasize the importance of real-world treatment monitoring. PSA remains a practical biomarker for assessing response and recurrence, particularly where advanced imaging and molecular testing are constrained [22]. However, PSA-based interpretation in retrospective records has limitations. Biochemical recurrence definitions vary according to treatment context, and a single threshold may not capture the complexity of patients receiving ADT, radiotherapy, or palliative systemic treatment. Future Sudanese oncology studies should record PSA longitudinally at standardized intervals and incorporate testosterone measurements to confirm biochemical castration. This is especially important because apparent PSA progression during ADT may reflect inadequate castration, non-adherence, delayed injections, or emerging castration-resistant disease.

The safety findings were broadly compatible with the known tolerability of medical castration, but they should be interpreted cautiously because adverse events were captured retrospectively. Loss of libido is expected with androgen suppression, while back pain in Group C probably reflects metastatic disease burden rather than direct goserelin toxicity. Recent real-world and phase III studies of goserelin formulations support durable testosterone and PSA suppression with no unexpected safety signals [17-19] Comparative evidence also suggests that GnRH antagonists provide faster testosterone suppression and avoid flare, but may have more injection-site reactions than GnRH agonists [23]. Broader systematic reviews continue to support LHRH agonists as clinically meaningful alternatives to orchiectomy [24].

Goserelin has generally been relatively well tolerated in clinical trials; adverse reactions in these trials were rarely severe enough to warrant the withdrawal of patients [6,7]. The overall adverse event profile of goserelin in this cohort demonstrated a broadly tolerable safety pattern, with the most common events being back pain, loss of libido, nocturia and limb pain. The total prevalence of any adverse event was 29.4%. Furthermore, the noted variations in the safety profile compared to the international one are consistent with pharmacovigilance literature related to several antineoplastic drugs among the Sudanese oncology patients [25-28].

Strengths and limitations

This study has several strengths. It used total-coverage sampling from a major Sudanese oncology referral centre, focused on clinically relevant biochemical outcomes, and compared real-world treatment patterns across localized and metastatic disease states. It also provides rare local data from a resource-limited African oncology setting where published prostate cancer treatment-outcome evidence remains scarce. However, limitations are important. The retrospective single-centre design limited control over missing data, follow-up intervals, treatment adherence, and adverse-event documentation. The sample was small, particularly in metastatic Group B. Treatment group and disease stage were fully confounded because all localized patients were in Group A and all metastatic patients were in Groups B and C. Loss to follow-up was high in the metastatic groups, which may bias PSA and recurrence estimates. Data on Gleason score, TNM stage, metastatic burden, radiotherapy dose, goserelin schedule, treatment duration, testosterone suppression, comorbidities, and survival were unavailable or incompletely recorded. Therefore, the findings should be interpreted as real-world audit evidence rather than definitive comparative effectiveness evidence.

Clinical implications

The study supports continued use of goserelin-based ADT as an effective biochemical-control strategy for localized prostate cancer in routine Sudanese practice. However, the poor PSA control in metastatic disease highlights an urgent need to review metastatic prostate cancer pathways, improve staging and follow-up, confirm castration biochemically, and expand access to evidence-based systemic intensification where feasible. At a health-system level, these findings support development of local prostate cancer treatment protocols, standardized PSA and testosterone monitoring, structured adverse-event documentation, and prospective registries to evaluate survival, progression, quality of life, and treatment access.

5. Conclusion

In this Sudanese retrospective cohort, goserelin plus bicalutamide achieved substantial PSA suppression and lower biochemical recurrence in localized prostate cancer. In metastatic disease, goserelin-based ADT, with or without radiotherapy, showed inadequate biochemical control and high recurrence rates. Goserelin appeared tolerable in routine records, but prospective toxicity assessment is needed. These findings highlight the need for local guideline development, improved metastatic disease monitoring, and access to contemporary systemic treatment intensification.

Declarations

Disclaimer (Artificial intelligence)

During the preparation of this work, the author(s) used OpenAI (2025), ChatGPT (July 19 version), to assist in summarizing portions of the original thesis draft and in generating descriptive text for tables and figures. All AI-assisted and generated content was reviewed, edited, and verified by the author(s), who take full responsibility for the final content of this paper.

Conflict of Interest

The authors declare that there is no conflict of interest

Funding/ financial support

This study received no specific grant from any funding agency in the public, commercial, or not-for-profit sector.

Contributors

Conceptualization: AE, LHE, MTA, and BAY; Methodology and Investigation: AE, LHE, MHA, MAM, SAA, EAAE; Data collection and curation: AE, LHE, MTA, KAO, YSK, EB, and BAY; Data curation, Visualization, Software: AE, LHE, MHA, MAM, SAA, EAAE, and BAY; Writing original draft: AE, LHE, MTA, KOA, YSK, and EB; Writing – review and editing: MHA, MAM, SAA, EAAE, and BAY; Supervision: BAY. All authors approved the final manuscript.

Ethical Clearance

The study was carried out in compliance with the 1975 Declaration of Helsinki and was approved by the Ethical Committee of the Faculty of Pharmacy at the University of Khartoum (FPEC-52-2021). Due to the retrospective nature of the study and the use of anonymous data, informed consent was waived by the ethics committees. Strict confidentiality and anonymity of participants’ data were maintained throughout the research process.

Acknowledgements

None

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