NCT04861194

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
15mo left

Started Jul 2021

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jul 2021Aug 2027

First Submitted

Initial submission to the registry

April 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 14, 2021

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2027

Last Updated

March 5, 2026

Status Verified

January 1, 2026

Enrollment Period

6.1 years

First QC Date

April 22, 2021

Last Update Submit

March 3, 2026

Conditions

Prostate CancerErectile Dysfunction Following Radiation Therapy

Outcome Measures

Primary Outcomes (1)

  • Erectile dysfuntion

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

    3 years

Secondary Outcomes (3)

  • Relapse-free survival

    3 years

  • Patient-reported quality of life

    3 years

  • Acute and late gastrointestinal and genitourinary toxicity

    3 years

Study Arms (1)

Neurovascular-sparing 5x7.25 Gy MRgRT

EXPERIMENTAL

MRgRT to the prostate in 5 fractions of 7.25 Gy, additionally sparing the neurovascular bundles, internal pudendal arteries, corpora cavernosa, and penile bulb

Radiation: Neurovascular-sparing

Interventions

Neurovascular-sparingRADIATION

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

Neurovascular-sparing 5x7.25 Gy MRgRT

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
  • Patients who are incompetent to sign written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3584CX, Netherlands

RECRUITING

Related Publications (1)

  • Roy A, Green O, Brenneman R, Bosch W, Gay HA, Michalski JM, Baumann BC. Assessing Inter-Fraction Changes in The Size and Position of The Penile Bulb During Daily MR-Guided Radiation Therapy to The Prostate Bed: Do We Need to Adjust How We Plan Radiation in The Post-Radical Prostatectomy Setting to Reduce Risk of Erectile Dysfunction? Clin Genitourin Cancer. 2022 Jun;20(3):e227-e232. doi: 10.1016/j.clgc.2022.01.006. Epub 2022 Jan 11.

    PMID: 35153154DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Jochem RN van der Voort van Zyp, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederik R Teunissen, MD

CONTACT

+31 (0)887550474f.r.teunissen@umcutrecht.nl

Jochem RN van der Voort van Zyp, MD PhD

CONTACT

j.r.n.vandervoortvanzyp@umcutrecht.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.dr.

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 27, 2021

Study Start

July 14, 2021

Primary Completion (Estimated)

August 10, 2027

Study Completion (Estimated)

August 10, 2027

Last Updated

March 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)