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NCT Number: NCT04642027

PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Radiotherapiegroep, Arnhem, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional sEBRT

Radiation

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

Other names: Conventional salvage external beam radiation therapy

Hypofractionated sEBRT

Radiation

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

Other names: Hypofractionated salvage external beam radiation therapy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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).

  5. 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

  6. 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).

  7. Prostate cancer-specific mortality

    Time frame: 5 years

    Prostate cancer-specific mortality.

  8. Overall survival

    Time frame: 5 years

    Overall survival

  9. 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).

  10. 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).

  11. 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).

  12. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

F. Staal, MD

CONTACT

[email protected]

0031655257985

P. Veldhuijzen van Zanten

CONTACT

[email protected]

0031503614659

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Dutch Cancer Society

Registry information

Official study title

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

Acronym: PERYTON

Important dates

Study start
2020
Primary completion
2029
Study completion
2030
First posted
Nov 24, 2020
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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