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

February 26, 2024 updated by: University Medical Center Groningen

PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy of Biochemical Failure After Radical Prostatectomy for Prostate Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

538

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713GZ
      • Vlissingen, Netherlands
        • Recruiting
        • Zuidwest Radiotherapeutisch Instituut (ZRTI)
        • Contact:
    • Friesland
      • Leeuwarden, Friesland, Netherlands
        • Recruiting
        • Radiotherapy Institute Friesland
        • Contact:
          • M. de Jong, MD
    • Gelderland
      • Arnhem, Gelderland, Netherlands
        • Recruiting
        • Radiotherapiegroep
        • Contact:
          • D. Haverkort, MD
      • Nijmegen, Gelderland, Netherlands
        • Recruiting
        • Radboud University Medical Center
        • Contact:
          • R.J. Smeenk, MD, PhD
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Recruiting
        • Maastro Clinic
        • Contact:
          • B. Vanneste, MD
    • Noord Brabant
      • Eindhoven, Noord Brabant, Netherlands
        • Recruiting
        • Catharina-Hospital
        • Contact:
          • T.C.G. Budiharto, MD, PhD
    • Noord-Brabant
      • Tilburg, Noord-Brabant, Netherlands
        • Recruiting
        • Verbeeten Institute
        • Contact:
          • M.A.E. van de Sande, MD
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands
        • Not yet recruiting
        • Amsterdam UMC (Location VUmc)
        • Contact:
          • J. van Moorselaar, Professor
    • Overijssel
      • Deventer, Overijssel, Netherlands
        • Recruiting
        • Radiotherapiegroep
        • Contact:
          • D. Haverkort, MD
    • Zuid-Holland
      • Den Haag, Zuid-Holland, Netherlands
        • Not yet recruiting
        • Haga hospital
        • Contact:
          • B. Hollman, MD
      • Leiden, Zuid-Holland, Netherlands
        • Not yet recruiting
        • Leiden University Medical Center
        • Contact:
          • S. Rademakers, MD, PhD
      • Rotterdam, Zuid-Holland, Netherlands
        • Not yet recruiting
        • Erasmus Medical Center
        • Contact:
          • L. Incocci, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional
Conventional sEBRT
Radiation: Conventional sEBRT
A total dose of70 Gy in 35 daily fractions of 2 Gy during 7 weeks
Other Names:
  • Conventional salvage external beam radiation therapy
Experimental: Hypofractionation
Hypofractionated sEBRT
Radiation: Hypofractionated sEBRT
A total dose of 60 Gy in 20 daily fractions of 3 Gy during 4 weeks
Other Names:
  • Hypofractionated salvage external beam radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year progression-free survival
Time Frame: 5 years
Defined as biochemical progression, clinical progression, loco-regional or distant progression or start with hormonal therapy, whichever occurs first
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute grade ≥ 2 gastrointestinal toxicity
Time Frame: Up to 3 months after completion of the RT
As assessed using physician-reported score: Common Terminology Criteria for adverse events version 5.0 (CTCAE-5) toxicity score with a scale of 1 - 4.
Up to 3 months after completion of the RT
Acute grade ≥ 2 genitourinary toxicities
Time Frame: Up to 3 months after completion of the RT
As assessed using physician-reported score using questionnaires (CTCAE 5.0 toxicity score).
Up to 3 months after completion of the RT
Late grade ≥ 2 gastrointestinal toxicity
Time Frame: Up to 5 years after completion of the RT
As assessed using physician-reported score (CTCAE 5.0 toxicity score).
Up to 5 years after completion of the RT
Late grade ≥ 2 genitourinary toxicity
Time Frame: Up to 5 years after completion of the RT
Using physician-reported score (CTCAE 5.0 toxicity score).
Up to 5 years after completion of the RT
Quality of life after radiation
Time Frame: Up to 5 years after completion of the RT
As assessed using patient-reported questionnaires: measurend with European platform of cancer research-QLQ C30
Up to 5 years after completion of the RT
Metastasis-free survival
Time Frame: 5 years
Time from randomisation to the date of metastases reported by CT scan, MRI scan or PSMA-PET/CT during the follow up (date scan).
5 years
Prostate cancer-specific mortality
Time Frame: 5 years
Prostate cancer-specific mortality.
5 years
Overall survival
Time Frame: 5 years
Overall survival
5 years
Acute grade ≥ 2 gastrointestinal toxicity
Time Frame: Up to 3 months after completion of the RT
Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
Up to 3 months after completion of the RT
Acute grade ≥ 2 genitourinary toxicities
Time Frame: Up to 3 months after completion of the RT
Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
Up to 3 months after completion of the RT
Late grade ≥ 2 genitourinary toxicity
Time Frame: Up to 5 years after completion of the RT
Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
Up to 5 years after completion of the RT
Quality of life after radiation
Time Frame: Up to 5 years after completion of the RT
As assessed using patient reported quatinnaires: European platform of cancer research-Quality of Life Questionnaire - Prostate Cancer Module (PR 25).
Up to 5 years after completion of the RT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Dutch Cancer Society

Investigators

  • Principal Investigator: S. Aluwini, Dr., UMCG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

August 13, 2020

First Submitted That Met QC Criteria

November 17, 2020

First Posted (Actual)

November 24, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT2020-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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