PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy

Last updated: February 26, 2024
Sponsor: University Medical Center Groningen
Overall Status: Active - Recruiting

Phase

3

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Prostate Disorders

Treatment

Hypofractionated sEBRT

Conventional sEBRT

Clinical Study ID

NCT04642027
RT2020-01
  • Ages 18-80
  • Male

Study Summary

After radical prostatectomy approximately 15-40% of men develop a biochemical recurrence (BR) within 5 years.

The standard treatment of post-prostatectomy BR is salvage external beam radiation therapy (sEBRT). sEBRT can provide long-term disease control; with 5 year biochemical progression-free survival (bPFS) up to 60% and with most treatment failures in the first 2 years after sEBRT.

The main goal of this project is to investigate whether the oncologic outcome in patients with post-prostatectomy recurrent PCa can be improved, by increasing the biological effective radiation dose using a hypofractionated schedule of 20 x 3 = 60 Gy.

The study is designed as a prospective open phase III randomized multicenter trial. All patients with biochemical recurrence with a PSA < 1.0 ng/ml after radical prostatectomy for prostate cancer without evidence of lymph nodes or distance metastases will be included. PSA progression after prostatectomy defined as two consecutive rises with the final PSA > 0.1 ng/mL or three consecutive rises will be included.

All eligible patients will be randomized to one of the following two treatment arms:

Arm 1 = Conventional sEBRT to apply a total dose of 70 Gy in 35 daily fractions of 2 Gy during 7 weeks.

Arm 2 = Hypofractionated sEBRT to apply a total dose of 60 Gy in 20 fractions of 3 Gy during 4 weeks.

The primary endpoint will be the 5-year progression-free survival (PFS) after treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with prostate adenocarcinoma treated with radical prostatectomy;
  • Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009, only withGleason score available;
  • No lymph node or distant metastases. A recent PSMA-PET scan (< 60 days) withoutevidence of lymph node or distant metastases;
  • PSA progression after prostatectomy defined as two consecutive rises with the finalPSA > 0.1 ng/mL or 3 consecutive rises. The first value must be measured at least 6weeks after radical prostatectomy;
  • PSA at inclusion < 1.0 ng/mL;
  • WHO performance status 0-2 at inclusion;
  • Age at inclusion between 18 and 80 years;
  • Written (signed and dated) informed consent prior to registration.

Exclusion

Exclusion Criteria:

  • Prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy;
  • Previous or concurrent active invasive cancers other than superficial non-melanomaskin cancers;
  • Patients with positive nodes or with distant metastases based on the surgical specimenof lymphadenectomy or the following minimum diagnostic workup: PSMA-PET/CT scan, 60days prior to registration;
  • Double-sided metallic hip prosthesis;
  • Inability or unwillingness to understand the information on trial-related topics, togive informed consent or to fill out QoL questionnaires.

Study Design

Total Participants: 538
Treatment Group(s): 2
Primary Treatment: Hypofractionated sEBRT
Phase: 3
Study Start date:
September 01, 2020
Estimated Completion Date:
September 01, 2030

Connect with a study center

  • Radiotherapy Institute Friesland

    Leeuwarden, Friesland
    Netherlands

    Active - Recruiting

  • Radiotherapiegroep

    Arnhem, Gelderland
    Netherlands

    Active - Recruiting

  • Radboud University Medical Center

    Nijmegen, Gelderland
    Netherlands

    Active - Recruiting

  • Maastro Clinic

    Maastricht, Limburg
    Netherlands

    Active - Recruiting

  • Catharina-Hospital

    Eindhoven, Noord Brabant
    Netherlands

    Active - Recruiting

  • Verbeeten Institute

    Tilburg, Noord-Brabant
    Netherlands

    Active - Recruiting

  • Amsterdam UMC (Location VUmc)

    Amsterdam, Noord-Holland
    Netherlands

    Site Not Available

  • Radiotherapiegroep

    Deventer, Overijssel
    Netherlands

    Active - Recruiting

  • Haga Hospital

    Den Haag, Zuid-Holland
    Netherlands

    Site Not Available

  • Leiden University Medical Center

    Leiden, Zuid-Holland
    Netherlands

    Site Not Available

  • Erasmus Medical Center

    Rotterdam, Zuid-Holland
    Netherlands

    Site Not Available

  • UMCG

    Groningen, 9713GZ
    Netherlands

    Active - Recruiting

  • Zuidwest Radiotherapeutisch Instituut (ZRTI)

    Vlissingen,
    Netherlands

    Active - Recruiting

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