AzTrials
AzTrials

Prostate CancerPhase 3PERYTONNCT04642027

PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy

A Phase 3 study testing Conventional sEBRT and Hypofractionated sEBRT in people with Prostate Cancer and Cancer Recurrence, run by University Medical Center Groningen at 13 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostate Cancer, Cancer Recurrence
What is being tested?
Conventional sEBRT and Hypofractionated sEBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
538 participants
Where
13 sitesNetherlands
Study dates
1 Sep 2020to 1 Sep 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

F. Staal, MD contact

0031655257985

f.h.e.staal@umcg.nl

P. Veldhuijzen van Zanten contact

0031503614659

peryton@rt.umcg.nl

13 sites in 1 country

Netherlands13 sites, 13 recruiting

  • Amsterdam UMC (Location VUmc)

    Amsterdam, North Holland

    J. van Moorselaar, Professor

    Not yet recruiting

  • Radiotherapiegroep

    Arnhem, Gelderland

    D. Haverkort, MD

    Recruiting

  • Radiotherapiegroep

    Deventer, Overijssel

    D. Haverkort, MD

    Recruiting

  • Catharina-Hospital

    Eindhoven, North Brabant

    T.C.G. Budiharto, MD, PhD

    Recruiting

  • Zuidwest Radiotherapeutisch Instituut (ZRTI)

    Flushing

    Inge Jacobs, i.jacobs@zrti.nl

    Recruiting

  • UMCG

    Groningen, 9713GZ

    F.H.E. Staal, MD., PERYTON@rt.umcg.nl

    Recruiting

  • Radiotherapy Institute Friesland

    Leeuwarden, Provincie Friesland

    M. De Jong, MD

    Recruiting

  • Leiden University Medical Center

    Leiden, South Holland

    S. Rademakers, MD, PhD

    Not yet recruiting

  • Maastro Clinic

    Maastricht, Limburg

    B. Vanneste, MD

    Recruiting

  • Radboud University Medical Center

    Nijmegen, Gelderland

    R.J. Smeenk, MD, PhD

    Recruiting

  • Erasmus Medical Center

    Rotterdam, South Holland

    L. Incocci, Professor

    Not yet recruiting

  • Haga Hospital

    The Hague, South Holland

    B. Hollman, MD

    Not yet recruiting

  • Verbeeten Institute

    Tilburg, North Brabant

    M.A.E. van de Sande, MD

    Recruiting

Other trials in Netherlands

About this study

Official title: 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.

Read more

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.

Being tested
Conventional sEBRT, Hypofractionated sEBRT
Keywords
PSMA-PET/CT, Salvage, Hypofractionation, Radiotherapy, Prostatectomy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional sEBRTRadiation

    Also called Conventional salvage external beam radiation therapy

    A total dose of70 Gy in 35 daily fractions of 2 Gy during 7 weeks

  • Hypofractionated sEBRTRadiation

    Also called Hypofractionated salvage external beam radiation therapy

    A total dose of 60 Gy in 20 daily fractions of 3 Gy during 4 weeks

Study groups in NCT04642027
Study groupRoleWhat they receive
ConventionalActive comparatorConventional sEBRT
Receives: Radiation: Conventional sEBRT
HypofractionationExperimentalHypofractionated sEBRT
Receives: Radiation: Hypofractionated sEBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 5-year progression-free survival

    Defined as biochemical progression, clinical progression, loco-regional or distant progression or start with hormonal therapy, whichever occurs first

    Measured: 5 years

Secondary outcomes (12)

  1. Acute grade ≥ 2 gastrointestinal toxicity

    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.

    Measured: Up to 3 months after completion of the RT

  2. Acute grade ≥ 2 genitourinary toxicities

    As assessed using physician-reported score using questionnaires (CTCAE 5.0 toxicity score).

    Measured: Up to 3 months after completion of the RT

  3. Late grade ≥ 2 gastrointestinal toxicity

    As assessed using physician-reported score (CTCAE 5.0 toxicity score).

    Measured: Up to 5 years after completion of the RT

  4. Late grade ≥ 2 genitourinary toxicity

    Using physician-reported score (CTCAE 5.0 toxicity score).

    Measured: Up to 5 years after completion of the RT

  5. Quality of life after radiation

    As assessed using patient-reported questionnaires: measurend with European platform of cancer research-QLQ C30

    Measured: Up to 5 years after completion of the RT

  6. Metastasis-free survival

    Time from randomisation to the date of metastases reported by CT scan, MRI scan or PSMA-PET/CT during the follow up (date scan).

    Measured: 5 years

  7. Prostate cancer-specific mortality

    Prostate cancer-specific mortality.

    Measured: 5 years

  8. Overall survival

    Overall survival

    Measured: 5 years

  9. Acute grade ≥ 2 gastrointestinal toxicity

    Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).

    Measured: Up to 3 months after completion of the RT

  10. Acute grade ≥ 2 genitourinary toxicities

    Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).

    Measured: Up to 3 months after completion of the RT

  11. Late grade ≥ 2 genitourinary toxicity

    Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).

    Measured: Up to 5 years after completion of the RT

  12. Quality of life after radiation

    As assessed using patient reported quatinnaires: European platform of cancer research-Quality of Life Questionnaire - Prostate Cancer Module (PR 25).

    Measured: Up to 5 years after completion of the RT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2020
  2. Study start1 Sep 2020
  3. Primary completion1 Sep 2029 (estimated)
  4. Study completion1 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 randomised arms
Masking
None (open label)
Enrolment
538 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04642027
Sponsor's protocol ID
RT2020-01
Acronym
PERYTON
Status last verified
Feb 2024
First submitted
13 Aug 2020
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Staal FHE, Janssen J, Oprea-Lager DE, Engelen AM, van Limbergen EJ, Smeenk RJ, de Jong MAA, Budiharto TCG, Jacobs I, Haverkort DMAD, Brouwer CL, Ng Wei Siang K, Langendijk JA, Verzijlbergen JF, de Jong IJ, Noordzij W, Aluwini S. Prostate-Specific Membrane Antigen Positron Emission Tomography/Computed Tomography-Based Clinical Target Volume Delineation Guideline for Postprostatectomy Salvage Radiation Therapy: The PERYTON Guideline. Int J Radiat Oncol Biol Phys. 2024 Mar 1;118(3):688-696. doi: 10.1016/j.ijrobp.2023.09.016. Epub 2023 Sep 18.

    PubMed 37729971

  • Staal FHE, Janssen J, Brouwer CL, Langendijk JA, Ng Wei Siang K, Schuit E, de Jong IJ, Verzijlbergen JF, Smeenk RJ, Aluwini S. Phase III randomised controlled trial on PSMA PET/CT guided hypofractionated salvage prostate bed radiotherapy of biochemical failure after radical prostatectomy for prostate cancer (PERYTON-trial): study protocol. BMC Cancer. 2022 Apr 15;22(1):416. doi: 10.1186/s12885-022-09493-5.

    PubMed 35428210

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Conventional sEBRT and Hypofractionated sEBRT in people with Prostate Cancer and Cancer Recurrence, run by University Medical Center Groningen at 13 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact F. Staal, MD (0031655257985, f.h.e.staal@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-year progression-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04642027, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in