PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-80
SponsorUniversity Medical Center Groningen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional sEBRT
RadiationA total dose of70 Gy in 35 daily fractions of 2 Gy during 7 weeks
Hypofractionated sEBRT
RadiationA total dose of 60 Gy in 20 daily fractions of 3 Gy during 4 weeks
Treatment groups
538 Participants
are divided into 2 treatment groupsGroup A: ConventionalActive comparator 1 intervention
Group B: HypofractionationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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
Time frame
5 yearsSecondary outcomes
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.
Time frame
Up to 3 months after completion of the RT2
Acute grade ≥ 2 genitourinary toxicities
As assessed using physician-reported score using questionnaires (CTCAE 5.0 toxicity score).
Time frame
Up to 3 months after completion of the RT3
Late grade ≥ 2 gastrointestinal toxicity
As assessed using physician-reported score (CTCAE 5.0 toxicity score).
Time frame
Up to 5 years after completion of the RT4
Late grade ≥ 2 genitourinary toxicity
Using physician-reported score (CTCAE 5.0 toxicity score).
Time frame
Up to 5 years after completion of the RTSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Medical Center Groningen
Lead sponsor
Dutch Cancer Society
Collaborator
Source ClinicalTrials.gov