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New treatment option for Prostate Carcinoma
Official title Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
ClinicalTrials.gov ID: NCT06717711
What this study is testing
What is PDE5 inhibitor (tadalafil)?
PDE5 inhibitor (tadalafil) is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for prostate carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This prospective randomized controlled trial (RCT) is designed to provide high level evidence on the efficacy of Low-intensity Extracorporeal Shock Wave Therapy (Li-ESWT) in the treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) erectile dysfunction (ED) in addition to PDE5 inhibitors (PDE5i) versus PDE5i alone. Our hypothesis is that early andrological rehabilitation that combines Li-ESWT and PDE5i could lead to faster and better recovery of valid erections for intercourse, with a greater rate of postoperative International Index of Erectile Function-5 (IIEF-5) compared to patients receiving PDE5i alone.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, men only
You may be able to join if
- Patients aged ≤75 yrs;
- PSA \<10 ng/mL
- Prostate Cancer ISUP grade ≤2 and cT≤2 at prostate biopsy
- undergoing nerve sparing RARP;
- preoperative IIEF-5 score ≥ 17;
You likely can't join if
- anaesthesiologic contraindications to robotic surgery
- patients submitted to pelvic radiotherapy or androgen deprivation
- patients reporting major postoperative complications (CD≥3)
- cardiovascular contraindications to PDE5i medical treatment
See the full eligibility criteria
- Patients aged ≤75 yrs;
- PSA \<10 ng/mL
- Prostate Cancer ISUP grade ≤2 and cT≤2 at prostate biopsy
- undergoing nerve sparing RARP;
- preoperative IIEF-5 score ≥ 17;
- First PSA (45d after surgery) \<0.1
- Prostate Cancer ISUP grade ≤2 pT\<3b and at final pathology
- ≥ 18 yrs old;
- compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires;
- patients able to provide a written informed consent for the trial.
- anaesthesiologic contraindications to robotic surgery
- patients submitted to pelvic radiotherapy or androgen deprivation
- patients reporting major postoperative complications (CD≥3)
- cardiovascular contraindications to PDE5i medical treatment
The study team makes the final eligibility decision.
Where it's taking place
- Rome, RM, Italy
- Naples, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, RM, Italy; Naples, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.