Health TrialsbyHealthPanel

EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT)

ConditionsProstate CancerErectile Dysfunction Following Radiation Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUMC Utrecht

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Neurovascular-sparing

    Radiation

    Dose reduction of the neurovascular bundles, internal pudendal arteries, corpora cavernosa, and penile bulb during 5x7.25 Gy MRgRT

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Neurovascular-sparing 5x7.25 Gy MRgRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Erectile dysfuntion

Erectile function score of ≤11 on the International Index of Erectile Function (IIEF) -5 questionnaire (0=worst; 25=best)

Time frame
3 years

Secondary outcomes

1

Relapse-free survival

Defined as biochemical relapse, or positive PSMA scan or clinical relapse whichever occurs first. Biochemical relapse is defined according to the Phoenix definition, i.e. a PSA greater than the current Nadir plus 2 ng/mL. Clinical relapse consists either of locoregional disease or distant metastases

Time frame
3 years
2

Patient-reported quality of life

According to the Expanded Prostate Cancer Index Composite short form (EPIC-26) questionnaire

Time frame
3 years
3

Acute and late gastrointestinal and genitourinary toxicity

According to the Common Terminology Criteria for Adverse Events version 5

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UMC Utrecht

Lead sponsor

Source ClinicalTrials.gov
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