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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04642027
Recruitment Status : Recruiting
First Posted : November 24, 2020
Last Update Posted : April 6, 2022
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Shafak Al-Uwini, University Medical Center Groningen

Brief 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Cancer Recurrence Radiation: Conventional sEBRT Radiation: Hypofractionated sEBRT Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 538 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 randomised arms
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Treatment
Official Title: PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy of Biochemical Failure After Radical Prostatectomy for Prostate Cancer
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2029
Estimated Study Completion Date : September 1, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: 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 Name: Hypofractionated salvage external beam radiation therapy




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642027


Contacts
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Contact: F. Staal, MD 0031655257985 f.h.e.staal@umcg.nl
Contact: P. Veldhuijzen van Zanten 0031503614659 peryton@rt.umcg.nl

Locations
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Netherlands
Radiotherapy Institute Friesland Recruiting
Leeuwarden, Friesland, Netherlands
Contact: M. De Jong, MD         
Radiotherapiegroep Recruiting
Arnhem, Gelderland, Netherlands
Contact: D. Haverkort, MD         
Radboud University Medical Center Recruiting
Nijmegen, Gelderland, Netherlands
Contact: R.J. Smeenk, MD, PhD         
Maastro Clinic Recruiting
Maastricht, Limburg, Netherlands
Contact: B. Vanneste, MD         
Catharina-Hospital Not yet recruiting
Eindhoven, Noord Brabant, Netherlands
Contact: T.C.G. Budiharto, MD, PhD         
Verbeeten Institute Recruiting
Tilburg, Noord-Brabant, Netherlands
Contact: M.A.E. van de Sande, MD         
Amsterdam UMC (Location VUmc) Not yet recruiting
Amsterdam, Noord-Holland, Netherlands
Contact: J. van Moorselaar, Professor         
Radiotherapiegroep Recruiting
Deventer, Overijssel, Netherlands
Contact: D. Haverkort, MD         
Haga Hospital Not yet recruiting
Den Haag, Zuid-Holland, Netherlands
Contact: B. Hollman, MD         
Leiden University Medical Center Not yet recruiting
Leiden, Zuid-Holland, Netherlands
Contact: S. Rademakers, MD, PhD         
Erasmus Medical Center Not yet recruiting
Rotterdam, Zuid-Holland, Netherlands
Contact: L. Incocci, Professor         
UMCG Recruiting
Groningen, Netherlands, 9713GZ
Contact: F.H.E. Staal, MD.       PERYTON@rt.umcg.nl   
Sponsors and Collaborators
University Medical Center Groningen
Dutch Cancer Society
Investigators
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Principal Investigator: S. Aluwini, Dr. UMCG
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shafak Al-Uwini, Principal Investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT04642027    
Other Study ID Numbers: RT2020-01
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shafak Al-Uwini, University Medical Center Groningen:
PSMA-PET/CT
Salvage
Hypofractionation
Radiotherapy
Prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Disease Attributes
Pathologic Processes