PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy (PERYTON)

  • STATUS
    Recruiting
  • End date
    Sep 1, 2030
  • participants needed
    538
  • sponsor
    University Medical Center Groningen
Updated on 23 April 2022

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.

Details
Condition Prostate Cancer, Cancer Recurrence
Treatment Conventional sEBRT, Hypofractionated sEBRT
Clinical Study IdentifierNCT04642027
SponsorUniversity Medical Center Groningen
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

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 with Gleason score available
No lymph node or distant metastases. A recent PSMA-PET scan (< 60 days) without evidence of lymph node or distant metastases
PSA progression after prostatectomy defined as two consecutive rises with the final PSA > 0.1 ng/mL or 3 consecutive rises. The first value must be measured at least 6 weeks 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 Criteria

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