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EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT) (ERECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04861194
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Helena M Verkooijen, UMC Utrecht

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Erectile Dysfunction Following Radiation Therapy Radiation: Neurovascular-sparing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT); a Prospective Phase II Trial
Actual Study Start Date : July 14, 2021
Estimated Primary Completion Date : August 10, 2025
Estimated Study Completion Date : August 10, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Neurovascular-sparing 5x7.25 Gy MRgRT
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
Dose reduction of the neurovascular bundles, internal pudendal arteries, corpora cavernosa, and penile bulb during 5x7.25 Gy MRgRT




Primary Outcome Measures :
  1. Erectile dysfuntion [ Time Frame: 3 years ]
    Erectile function score of ≤11 on the International Index of Erectile Function (IIEF) -5 questionnaire (0=worst; 25=best)


Secondary Outcome Measures :
  1. Relapse-free survival [ Time Frame: 3 years ]
    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

  2. Patient-reported quality of life [ Time Frame: 3 years ]
    According to the Expanded Prostate Cancer Index Composite short form (EPIC-26) questionnaire

  3. Acute and late gastrointestinal and genitourinary toxicity [ Time Frame: 3 years ]
    According to the Common Terminology Criteria for Adverse Events version 5



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04861194


Contacts
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Contact: Frederik R Teunissen, MD +31 (0)887550474 f.r.teunissen@umcutrecht.nl
Contact: Jochem RN van der Voort van Zyp, MD PhD j.r.n.vandervoortvanzyp@umcutrecht.nl

Locations
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Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584CX
Contact: Frederik R Teunissen, MD       f.r.teunissen@umcutrecht.nl   
Principal Investigator: Ruud C Wortel, MD PhD         
Sub-Investigator: Frederik R Teunissen, MD         
Principal Investigator: Jochem RN van der Voort van Zyp, MD PhD         
Sponsors and Collaborators
UMC Utrecht
Investigators
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Principal Investigator: Jochem RN van der Voort van Zyp, MD PhD UMC Utrecht
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helena M Verkooijen, Prof.dr., UMC Utrecht
ClinicalTrials.gov Identifier: NCT04861194    
Other Study ID Numbers: NL73192.041.20
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders