Table 5.

Notable ongoing trials in focal therapy

Trial number identifier	Focal ablation modality	Phase	Description	Intended no. patients	Selection criteria	Key outcomes
NCT01194648	HIFU	Phase II	Multi-centre Single-arm	272	T1–T3a Gleason ≤ 4 + 3 PSA < 15 ng/ml	Proportion of men free of any cancer and free of clinically significant prostate cancer at 36 months on TPM
NCT00988130	HIFU	Phase II	Single-centre Single-arm Index lesion ablation	26	≤T3b Gleason ≤ 8 PSA ≤ 20 ng/ml	Side-effects and quality of life Absence of cancer in treated area at 12 months by TRUS biopsy
NCT01310894	PDT	Phase III	Multi-centre RCT Active surveillance versus focal therapy	400	≤T2c Gleason ≤ 3 + 3 PSA ≤ 10 mg/ml	Rate of absence of definite cancer at 24 months Rate of failure with observed progression of disease from low risk to higher risk
NCT01094665	Photothermal	Phase I/II	Single-centre Single-arm	60	T1–T2a PSA < 15 ng/ml	Absence of cancer at 4 months on TRUS biopsy
NCT01354951	LDR-brachytherapy	Phase II	Single-centre Single-arm	80	T1c-T2a Gleason 7 in two cores or less PSA < 10 ng/ml	Toxicity at 6 months to 2 years Absence of cancer at 12 and 24 months on biopsy
NCT00807820	HDR-brachytherapy	Phase I	Single-centre Single-arm Selective boost to DIL	56	T2a–2b, Gleason 2–6, PSA 10–20 ng/ml or T3a–3b, Gleason 2–6, PSA ≤ 20 ng/ml or T2a–3b, Gleason 7–10, PSA ≤ 20 ng/ml	Rate of ≥ grade 3 genitourinary or gastrointestinal toxicity at 12 months
NCT01423006	RFA	Phase I	Single-centre Single-arm	7	T1c Gleason ≤ 6 PSA < 10 ng/ml	Absence of cancer at 6 months on biopsy
NCT01726894	IRE	Phase I	Single-centre Single-arm	20	T1–T2c Gleason ≤ 7 PSA ≤ 15 ng/ml	Adverse events at 12 months

HIFU, high-intensity focussed ultrasound; PDT, photodynamic therapy; LDR, low dose rate; HDR, high dose rate; RFA, radiofrequency ablation; IRE, irreversible electroporation; RCT, randomised controlled trial; DIL, dominant intra-prostatic lesion; TPM, transperineal template mapping prostate biopsy; TRUS, transrectal ultrasound; PSA, prostate-specific antigen.