Effect of neoadjuvant androgen deprivation therapy on prostate and tumor morphology prior to MRI-guided transurethral ultrasound ablation of prostate cancer.
Short-term neoadjuvant therapy with degarelix resulted in significant reductions in prostate size and PSA levels, which may improve the feasibility of subsequent ultrasound ablation treatments.
Where it sits
this study against the rest of the degarelix corpusSummary and findings
This study evaluated the effects of 3-month neoadjuvant androgen deprivation therapy (nADT) with degarelix on prostate and tumor morphology in 15 treatment-naïve patients with intermediate-risk prostate cancer. Significant reductions in prostate volume, PSA levels, and index lesion volume were observed. The findings suggest potential improvements in the feasibility of MRI-guided transurethral ultrasound ablation (TULSA).
Abstract
<h4>Background</h4>Thermal ablation is a minimally invasive treatment for localized prostate cancer (PCa). MRI-guided transurethral ultrasound ablation (TULSA) enables precise, temperature-controlled therapy, but its 3 cm ablation radius may limit coverage in large prostates or capsule-adjacent tumors. Neoadjuvant androgen deprivation therapy (nADT) may improve treatment feasibility by reducing prostate and tumor size.<h4>Methods</h4>In this prospective, single-arm pilot study (NCT05917860), 15 treatment-naïve patients with organ-confined, intermediate-risk ISUP 2-3 PCa and at least one biopsy-concordant PI-RADS ≥ 3 lesion received 3-month nADT with degarelix before whole-gland TULSA. Multiparametric MRI was performed at baseline and monthly thereafter to assess prostate and lesion volumes, tumor-capsule relationship, and urethra-capsule distance.<h4>Results</h4>All patients completed nADT. Across 27 PI-RADS ≥ 3 lesions, four patients had unifocal disease, and 11 had multifocal disease (2-3 lesions). Twenty lesions were ISUP Grade Group 2 and three were Grade Group 3. PSA declined by 87% (-7.6 ng/mL; 95% CI. -9.7 to -5.7; <i>p</i> < 0.001), and all patients achieved castrate testosterone levels. Prostate volume decreased by 26% (-15 mL; 95% CI. -20 to -12; <i>p</i> < 0.001), index lesion volume by 69% (-0.8 mL; 95% CI. -1.2 to -0.5; <i>p</i> < 0.001), and index-lesion capsule contact length by 40% (-5 mm; 95% CI. -7 to -4; <i>p</i> < 0.001). Capsule bulging resolved in four of seven patients, and urethra-capsule distance decreased to ≤ 30 mm in all six patients with a baseline distance > 30 mm.<h4>Conclusion</h4>Short-term nADT with degarelix was associated with significant changes in prostate and tumor morphology. Future studies should determine whether these changes improve TULSA outcomes.
Background
This paper addresses the impact of neoadjuvant androgen deprivation therapy (nADT) on prostate cancer morphology prior to MRI-guided transurethral ultrasound ablation (TULSA). Previous studies have indicated that nADT may reduce prostate size and improve treatment feasibility, but specific effects on tumor morphology and treatment outcomes remain unclear. Understanding these changes is critical for optimizing TULSA in patients with larger prostates or tumors adjacent to the capsule.
Methods
This was a prospective, single-arm pilot study involving 15 treatment-naïve patients diagnosed with organ-confined, intermediate-risk prostate cancer (ISUP 2-3). Participants received 3 months of nADT with degarelix before undergoing whole-gland TULSA. Multiparametric MRI assessments were conducted at baseline and monthly to evaluate prostate and lesion volumes, tumor-capsule relationships, and urethra-capsule distances.
Results
All 15 patients completed the nADT regimen. The primary endpoint showed a PSA decline of 87% (-7.6 ng/mL; 95% CI. -9.7 to -5.7; p < 0.001). Prostate volume decreased by 26% (-15 mL; 95% CI. -20 to -12; p < 0.001), and index lesion volume decreased by 69% (-0.8 mL; 95% CI. -1.2 to -0.5; p < 0.001). Additionally, index-lesion capsule contact length decreased by 40% (-5 mm; 95% CI. -7 to -4; p < 0.001).
Interpretation
The findings indicate significant reductions in PSA, prostate volume, and index lesion volume, which may suggest a favorable impact on the feasibility of TULSA. However, while the statistical significance is clear, the clinical significance of these changes in terms of long-term outcomes remains uncertain. The study's limitations, including the small sample size and lack of a control group, restrict the ability to draw definitive conclusions about the efficacy of nADT in improving TULSA outcomes.
Key findings
- PSA declined by 87% (-7.6 ng/mL; 95% CI. -9.7 to -5.7; p < 0.001)
- Prostate volume decreased by 26% (-15 mL; 95% CI. -20 to -12; p < 0.001)
- Index lesion volume decreased by 69% (-0.8 mL; 95% CI. -1.2 to -0.5; p < 0.001)
- Index-lesion capsule contact length decreased by 40% (-5 mm; 95% CI. -7 to -4; p < 0.001)
- Capsule bulging resolved in four of seven patients
- Urethra-capsule distance decreased to ≤ 30 mm in all six patients with a baseline distance > 30 mm
Limitations
- small n=15 pilot study
- single-arm design without a control group
- short follow-up duration
- no assessment of long-term clinical outcomes