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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04642027
Other study ID # RT2020-01
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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