Table 6. List of main studies assessing salvage therapies after FT failure.
Author (ref) | Year | Study design | Salvage therapy investigated | Population characteristics pre-salvage therapy | Key findings | ||
---|---|---|---|---|---|---|---|
Peri-operative | Outcomes | ||||||
Pierrard et al. (54) | 2019 | Retrospective study on 42 patients which underwent vascular targeted photodynamic therapy (TOOKAD®). Intervention type: 16 were RARP, 6 were laparoscopic and 20 were open surgery | Non-comparative, descriptive study of sRARP | Median age at RP: 65 years, mean PSA 5.9 ng/mL, post-FT positive biopsies before salvage: cancer in treated lobe: 63%, cancer in non-treated lobe: 67, bilateral cancer: 33% | Surgical feasibility: median operative time: 180 min (IQR 150–223), median blood loss: 200 mL (IQR 155–363), perceived difficulty: easy in 69%, difficult in 31% | Oncological and functional outcomes: PSM in 31%, undetectable PSA at 1 yr in 88%, 4/42 had final PSA >0.2 ng/mL at 23 months (IQR 12–36), at 1 year 64% were completely continent (no pads) and 24% had low incontinence (1 pad), 11% recovered potency without treatment and 64% recovered potency with appropriate treatment | |
Bhat et al. (55) | 2021 | Retrospective study on 53 patients who underwent sRARP following failure of FT compared to a matched control sample of men who had undergone primary RARP | sRARP vs. pRARP | sRARP: Mean PSA 3.2 ng/mL Pre-operative ISUP GG: ≤ GG2 49%, ≥ GG3 50% Pre-op SHIM score: 18 Pre-op AUA symptom score: 8 |
pRARP: Mean PSA 3.6 ng/mL Pre-operative ISUP GG: ≤ GG2 62%, ≥ GG3 38% Pre-op SHIM score: 16Pre-op AUA symptom score: 8 |
Surgical comparison: operative time: 121 min vs. 108 min (sRARP vs. pRARP), median blood loss: 100 mL in both groups, degree of full nerve sparing: 0% vs. 32% (sRARP vs. pRARP), degree of partial nerve sparing: 85% vs. 66% (sRARP vs. pRARP), post-operative Clavien-Dindo score 1–2: 21% vs. 11% (sRARP vs. pRARP; NS) | Oncological outcomes: PSM incidence: 40% vs. 15% (sRARP vs. pRARP), pN+: 9.4% vs. 5.7% (sRARP vs. pRARP), BCR-free at 3 yrs: 64% vs. 81% (sRARP vs. pRARP; NS), BCR at 3 yrs: 17.0% vs. 13.2% (sRARP vs. pRARP; NS), PSA persistence: 15.1% vs. 5.6% (sRARP vs. pRARP; NS) |
Functional outcomes: continence at 3 yrs (no pads): 54.7% vs. 83% (sRARP vs. pRARP), potency (non-pharmacological): 13.2% vs. 34% (sRARP vs. pRARP), patients with 2 FT treatments prior sRARP 57.1% were incontinent; 100% impotent | |||||||
Nunes-Silva et al. (56) | 2017 | Retrospective matched analysis of 22 men who underwent sRARP and 44 patients treated with pRARP. | sRARP vs. pRARP | sRARP: Mean PSA 9.24 ng/mL D’Amico risk group: low risk 27.3%, intermediate risk 59.1%, high risk 13.6% TNM: T1c 90.9%, T2a 9.1%, no differences in IPSS/IIEF5 score |
pRARP: Mean PSA 8.73 ng/mL D’Amico risk group: low risk 29.5%, intermediate risk 56.8%, high risk 13.6% TNM: T1c 79.5%, T2a 20.4%, No differences in IPSS/IIEF5 score |
Surgical comparison: mean operative time, hospital stay, catheterization time, blood loss and complications were comparable in sRARP and pRARP, degree of full nerve sparing: No 9% vs. 2%; unilateral 36% vs. 13%; bilateral 54% vs. 84% (sRARP vs. pRARP) | Oncological outcomes: comparable PSM between two groups, BCR-free survival at 2 years: 56% vs. 92% (sRARP vs. pRARP) Functional Outcomes: Continence at 2 yrs (no pads): 73% vs. 76% (sRARP vs. pRARP; NS), IIEF-5 score in patients which underwent unilat. Or bilat. Nerve Sparing at 1 yr: 3 vs. 9 (sRARP vs. pRARP) |
Nathan et al. (57) | 2022 | Prospective study comparing 100 patients undergoing sRARP vs. 100 patients undergoing sRT | sRARP vs.
sRT |
sRARP:Mean PSA 5.8 ng/mL D’Amico risk group: low risk 0%, intermediate risk 34%, high risk 66% TNM: T1 2%, T2 61%, ≥T3 37% |
sRT: Mean PSA 4.6 ng/mL D’Amico risk group: low risk 1%, intermediate risk 51%, high risk 48% TNM: T1 0%, T2 64.9%, ≥T3 35% |
Therapy derived complications: sRT: bowel RTOG grade 1-3: 39%, urinary RTOG grade 1-3: 61%; sRARP: Clavien-Dindo 1-3: 9% | Oncological Outcomes: comparable BCR overall, BCR in High-risk: 21% vs. 10% (sRARP vs. sRT), cancer-specific Mortality: 0% vs. 4% (sRARP vs. sRT) |
Functional Outcomes: continence at 2 yrs (no pads): 84% vs. 74% (sRARP vs. sRT), potency at 2 years: 21% vs. 73% (sRARP vs. sRT) |
FT, focal therapy; PSA, prostate-specific antigen; IQR, interquartile range; RARP, robotic-assisted radical prostatectomy; pRARP, primary robotic-assisted radical prostatectomy; sRARP, salvage robotic-assisted radical prostatectomy; PSM, positive surgical margins; pN+, positive lymph nodes at pathology; NS, non significant; sRT, salvage radiation therapy; IPSS, International Prostatic Symptoms Score; IIEF5, The International Index of Erectile Function; SHIM, Sexual Health Inventory for Men; RP, radical prostatectomy.