PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy

Prostate Cancer Clinical Trial

— PERYTON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04642027
• Other study ID #: RT2020-01
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2020
• Est. completion date: September 1, 2030

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: F. Staal, MD
• Phone: 0031655257985
• Email: f.h.e.staal[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 538
• Est. completion date: September 1, 2030
• Est. primary completion date: September 1, 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Recurrence
• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

Intervention

Radiation:
• Conventional sEBRT
A total dose of70 Gy in 35 daily fractions of 2 Gy during 7 weeks
• Hypofractionated sEBRT
A total dose of 60 Gy in 20 daily fractions of 3 Gy during 4 weeks

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC (Location VUmc)	Amsterdam	Noord-Holland
Netherlands	Radiotherapiegroep	Arnhem	Gelderland
Netherlands	Haga Hospital	Den Haag	Zuid-Holland
Netherlands	Radiotherapiegroep	Deventer	Overijssel
Netherlands	Catharina-Hospital	Eindhoven	Noord Brabant
Netherlands	UMCG	Groningen
Netherlands	Radiotherapy Institute Friesland	Leeuwarden	Friesland
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland
Netherlands	Maastro Clinic	Maastricht	Limburg
Netherlands	Radboud University Medical Center	Nijmegen	Gelderland
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland
Netherlands	Verbeeten Institute	Tilburg	Noord-Brabant
Netherlands	Zuidwest Radiotherapeutisch Instituut (ZRTI)	Vlissingen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year progression-free survival	Defined as biochemical progression, clinical progression, loco-regional or distant progression or start with hormonal therapy, whichever occurs first	5 years
Secondary	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.	Up to 3 months after completion of the RT
Secondary	Acute grade = 2 genitourinary toxicities	As assessed using physician-reported score using questionnaires (CTCAE 5.0 toxicity score).	Up to 3 months after completion of the RT
Secondary	Late grade = 2 gastrointestinal toxicity	As assessed using physician-reported score (CTCAE 5.0 toxicity score).	Up to 5 years after completion of the RT
Secondary	Late grade = 2 genitourinary toxicity	Using physician-reported score (CTCAE 5.0 toxicity score).	Up to 5 years after completion of the RT
Secondary	Quality of life after radiation	As assessed using patient-reported questionnaires: measurend with European platform of cancer research-QLQ C30	Up to 5 years after completion of the RT
Secondary	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).	5 years
Secondary	Prostate cancer-specific mortality	Prostate cancer-specific mortality.	5 years
Secondary	Overall survival	Overall survival	5 years
Secondary	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).	Up to 3 months after completion of the RT
Secondary	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).	Up to 3 months after completion of the RT
Secondary	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).	Up to 5 years after completion of the RT
Secondary	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).	Up to 5 years after completion of the RT