What is the mechanism of action of this treatment?

The most common treatments for prostate cancer include surgical techniques like radical prostatectomy, radiation therapy, and androgen deprivation therapy (ADT). Radical prostatectomy, including the pelvic fascia-sparing approach, involves the surgical removal of the prostate gland and aims to achieve cancer control while preserving urinary and sexual function by sparing surrounding tissues. This matters for patients as it can potentially reduce complications such as urinary incontinence and erectile dysfunction. Radiation therapy uses high-energy rays to target and kill cancer cells, while ADT reduces testosterone levels to slow the growth of cancer. Each treatment has distinct mechanisms and side effects, and the choice depends on the cancer's stage and the patient's overall health and preferences.

What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including radical prostatectomy and radiation therapy, have several known side effects. Radical prostatectomy, including techniques like Pelvic Fascia-Sparing Radical Prostatectomy, often results in urinary incontinence and sexual dysfunction, with some patients experiencing these issues long-term. Radiation therapy can lead to bowel symptoms such as urgency and frequency, and also contributes to sexual dysfunction. Both treatments can significantly impact quality of life, with urinary and sexual function being more affected by surgery, and bowel function more affected by radiation.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including surgical techniques and pharmaceuticals. One notable surgical technique is the radical prostatectomy, which has various approaches such as retropubic, perineal, and robotic-assisted methods. The Pelvic Fascia-Sparing Radical Prostatectomy is a newer technique aimed at preserving the pelvic fascia to improve urinary function and reduce complications. In terms of pharmaceuticals, the FDA has approved drugs like sipuleucel-T for castration-resistant prostate cancer (CRPC) and abiraterone in combination with ADT for advanced prostate cancer, both of which aim to prolong overall survival and improve quality of life.

What other types of research exist?

Promising alternatives to Pelvic Fascia-Sparing Radical Prostatectomy for prostate cancer patients include: 1) Robot-assisted laparoscopic prostatectomy, which has shown superior quality of life and improved surgical margins after a long learning curve. 2) Bladder-sparing trimodal therapy, which combines chemoradiation and partial cystectomy, offering a less invasive option with comparable outcomes. 3) Nerve-sparing techniques in radical cystectomy, which have shown promising results in preserving sexual and urinary function. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Procedure

Surgical Approaches for Prostate Cancer (PARTIAL Trial)

N/A

Recruiting

Led By Jim C Hu, MD, MPH

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for radical prostatectomy for clinically localized prostate cancer

Male sex

Must not have

Prior major pelvic surgery or radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial compares a new type of prostate cancer surgery to the standard one. The new surgery aims to avoid cutting important tissues and nerves, which might help reduce side effects like urinary problems and sexual dysfunction. The study will see if this new method controls cancer just as well while improving quality of life.

Who is the study for?

This trial is for men aged 40-80 who are scheduled for prostate cancer surgery, can understand English or Spanish, and agree to follow the study rules. It's not for those with advanced lymph node involvement or a history of major pelvic surgery/radiotherapy.

What is being tested?

The study compares two types of prostate cancer surgeries: standard robot-assisted radical prostatectomy (RP) and a nerve-sparing version called PFS-RP. The goal is to see if PFS-RP offers better urinary function and sexual health without compromising cancer control.

What are the potential side effects?

Potential side effects from both surgeries may include changes in urinary function, sexual health issues like erectile dysfunction, penile shortening/deformity, and possibly an increased risk of developing inguinal hernia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery to remove my prostate due to cancer.

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I am male.

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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had major surgery or radiation treatment in my pelvic area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 6 months, 12 months, and 24 months post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

Surgical Margin Status as assessed by surgical pathology results

Secondary study objectives

Change in Patient-Reported Penile Shortening and Sexual Function, as measured by a 5-item questionnaire

Change in Urinary and Sexual Function, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)

Change in patient-Reported Penile Curvature/Deformity (Peyronie's Disease), as measured by a 3-item questionnaire

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)Experimental Treatment1 Intervention

A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate. These structures are disrupted and removed during conventional radical prostatectomy.

Group II: Robot-assisted radical prostatectomy (RP)Active Control1 Intervention

The conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for prostate cancer include surgical techniques like radical prostatectomy, radiation therapy, and androgen deprivation therapy (ADT). Radical prostatectomy, including the pelvic fascia-sparing approach, involves the surgical removal of the prostate gland and aims to achieve cancer control while preserving urinary and sexual function by sparing surrounding tissues. This matters for patients as it can potentially reduce complications such as urinary incontinence and erectile dysfunction. Radiation therapy uses high-energy rays to target and kill cancer cells, while ADT reduces testosterone levels to slow the growth of cancer. Each treatment has distinct mechanisms and side effects, and the choice depends on the cancer's stage and the patient's overall health and preferences.

Prostate Leiomyosarcoma: A Rare Misleading Tumor.Extraperitoneal laparo-endoscopic single-site radical prostatectomy: first experience.Critical appraisal of outcomes following open radical prostatectomy.