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Focal Cryotherapy of localized tumor of prostate after spatial definition by in-house extended perineal core biopsy using a template biopsy strategy under local or general anesthesia

Cryotherapy is administered via the perineum under ultrasound guidance by third-generation 17-gauge cryoprobes using gas and thermal couples. Under transrectal ultrasound guidance cryoprobes are placed approximately 1 cm apart and within 5 mm of the capsule on the side of tumor. The extent of freezing was limited to the area or lobe of the gland with histologically proved tumor.

Focal Cryoablation

Giorgio Guazzoni, MD

Surgery and irradiation for organ confined prostate cancer provide excellent long-term cancer control but they may be accompanied by a risk of side effects that decrease quality of life. Due to the stage migration of prostate cancer, the potential for patients to undergo unnecessary treatment and the risk of treatment related morbidity, has been increased.Alternative strategies that offer the possibility of delaying, obviating or minimizing the impact of treatment maintaining the same oncological long term results have been investigated. Despite pros and cons active surveillance has not gained popularity in men with low risk prostate cancer as only 7% of men with localized prostate cancer remain in active surveillance.

Traditionally solid tumors have been treated with radical surgery but selective, organ sparing therapies are now common for tumors of the breast, skin and kidney, resulting in equivalent rates of cancer control, lower morbidity rates and less disfigurement. With this in mind the potential role of focal ablative therapy for localized prostate cancer might be considered.

The researchers will investigate the feasibility and the efficacy in term of quality of life and oncologic results of focal therapy by a pilot not randomized prospective study in a patients with localized prostate cancer who meet low risk criteria based on clinical, biopsy and imaging data.

Prostate cancer is a considerable health risk for men throughout the world. In the United States, prostate cancer has been the second or third leading cause of cancer death in men in each of the last 75 years. In the European Union, an estimated 68,000 men died of prostate cancer in 2004, making it the third most common cause of cancer related death While prostate cancer mortality in East Asian countries remains lower than that in Europe and the United States, it has been continuously and dramatically increasing in the last 40 years. With the introduction of PSA screening test and transrectal ultrasound guided prostate biopsy, the detection rate of prostate carcinoma has markedly improved. Surgery and irradiation each provide excellent long-term cancer control but they may be accompanied by a risk of side effects that decrease quality of life. Since some of prostate cancers grow slowly and, even if untreated, might never progress to symptomatic disease, patients and clinicians face the dilemma of if, when and how to treat localized prostate cancer. Due to the stage migration of prostate cancer, the potential for patients to undergo unnecessary treatment and the risk of treatment related morbidity, there has been, in the last years, an increased interest in alternative strategies that offer the possibility of delaying, obviating or minimizing the impact of treatment maintaining the same oncological long term results. One such strategy is active surveillance with selective delayed intervention. Active surveillance consists of appropriate selection of patients to safely avoid radical treatment and its attendant potential for morbidity, regular and rigorous monitoring of the cancer via physical examination, PSA, biopsies and imaging and initiation of treatment with curative intent at any clinical, pathological or radiographic evidence of disease progression. Despite pros and cons have recently addressed, active surveillance has not gained popularity in men with low risk prostate cancer (only around 7% of men with localized prostate cancer in the Cancer of the Prostate Strategic Urologic Research Endeavor national registry have elected to undergo active surveillance as the initial treatment options). Traditionally solid tumors have been treated with radical surgery but selective, organ sparing therapies are now common for tumors of the breast, skin and kidney, resulting in equivalent rates of cancer control, lower morbidity rates and less disfigurement. With this in mind the potential role of focal ablative therapy for localized prostate cancer might be considered. We investigate the feasibility and the efficacy in term of quality of life and oncologic results of focal therapy by a pilot not randomized prospective study in a patients with localized prostate cancer who meet low risk criteria based on clinical, biopsy and imaging data.

Investigative Study of the Role of Focal Therapy for Prostate Cancer Treatment

Focal Therapy for Organ Confined Prostate Cancer: an Investigative Prospective Pilot Study

Università Vita-Salute San Raffaele

Prof. Guazzoni Giorgio

Cryoablation is a procedure in which special needles are inserted into the tumor site.

Participants will have the Focal cryoablation placed by the needles in such a way that the area of affected tissue is much smaller and focus just on the tumor tissue and surrounding area

Participants will receive a prostate biopsy.

Standard of Care

Participants will fill out questionnaires.

Quality-of-life Questionnaires

Justin Gregg, MD

To learn if using cryotherapy to treat only the part of the prostate known to contain cancer is effective in controlling prostate cancer

Primary Objective:

• To determine the effectiveness of an evidence-based focal cryotherapy ablation by measuring negative in-field recurrence rate at 6-months post-ablation.

Secondary Objectives:

* To determine quality of life following focal prostate cancer ablation using validated questionnaires (EPIC-26, AUA symptoms score, SHIM).
* To establish PSA kinetics post-evidence-based focal cryotherapy ablation.
* To determine rates of out of field recurrence on 6-month biopsy following focal cryotherapy ablation.
* To determine MRI findings post-focal cryotherapy ablation, including those related to prostate and surrounding periprostatic fat volume.
* To determine rate of progression and re-intervention collected as part of standard of care treatment for 5-year following study treatment.
* To describe financial toxicity associated with focal prostate cancer treatment using cryotherapy.
* To describe the incidence and severity of complications within 30-days after the study focal ablation treatment.
* To describe imaging findings on PSMA PET MRI performed in a subset of men after standard of care focal cryotherapy prior to 6-month biopsy.

An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer

Score scale ranges (0-5) 0-Not at all/5- Almost always

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Investigative Study of the Role of Focal Therapy for Prostate Cancer Treatment	NCT00928603	Prostate Cancer	Focal Cryoablat...	18 Years - 76 Years	Università Vita-Salute San Raffaele
An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer	NCT05454488	Prostate Cancer	Focal Cryoablat... Standard of Car... Quality-of-life...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for focal cryoablation