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New treatment option for Prostate Cancer
Official title EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT)
ClinicalTrials.gov ID: NCT04861194
What this study is testing
- What it's testing
- Single-arm phase II trial of 70 men with low- or intermediate-risk prostate cancer receiving magnetic resonance guided adaptive radiotherapy (MRgRT) in 5 fractions of 7.25 Gy, additionally sparing the neurovascular bundles, the internal pudendal arteries, the corpora cavernosa, and the penile bulb for erectile function preservation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Age ≥18 years
- Histologically proven adenocarcinoma of the prostate
- Low-risk or intermediate-risk prostate cancer according to NCCN risk categories (low risk: T1c-T2a, Gleason score ≤6, and PSA \<10 µg/L; intermediate...
- Patients with pT1a/b tumor diagnosis after transurethral resection of the prostate (TURP)
- Domain score of 17-25 on the International Index of Erectile Function-5 (IIEF-5) questionnaire
You likely can't join if
- Use of (neo-)adjuvant androgen deprivation therapy
- High-risk prostate cancer according to NCCN risk categories (T3a or Gleason score 8-10 or PSA \>20 µg/L)
- Patients with "bulky" iT3 tumor diagnosis
- Previous pelvic irradiation or radical prostatectomy
- Clinical evidence of metastatic disease
- Patients who are unable to undergo MRI
See the full eligibility criteria
- Age ≥18 years
- Histologically proven adenocarcinoma of the prostate
- Low-risk or intermediate-risk prostate cancer according to NCCN risk categories (low risk: T1c-T2a, Gleason score ≤6, and PSA \<10 µg/L; intermediate risk: T2b-T2c or Gleason score 7 or PSA 10-20 µg/L)
- Patients with pT1a/b tumor diagnosis after transurethral resection of the prostate (TURP)
- Domain score of 17-25 on the International Index of Erectile Function-5 (IIEF-5) questionnaire
- Karnofsky score of 70-100
- Written informed consent
- Use of (neo-)adjuvant androgen deprivation therapy
- High-risk prostate cancer according to NCCN risk categories (T3a or Gleason score 8-10 or PSA \>20 µg/L)
- Patients with "bulky" iT3 tumor diagnosis
- Previous pelvic irradiation or radical prostatectomy
- Clinical evidence of metastatic disease
- Patients who are unable to undergo MRI
- Patients who are incompetent to sign written informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Utrecht, Utrecht, Netherlands
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Utrecht, Utrecht, Netherlands. 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.