NCT04642027RecruitingPhase 3
PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy
PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy of Biochemical Failure After Radical Prostatectomy for Prostate Cancer
Source: ClinicalTrials.gov · Last updated 28 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 538 (estimated)
- First submitted
- 13 Aug 2020
- Start date
- 1 Sept 2020
- Primary completion date
- 1 Sept 2029
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Prostate cancer
- NCT number
- NCT04642027
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 538
- From 1 Sept 2020 to the primary completion date, 1 Sept 2029
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC location VUmc Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Radiotherapiegroep Coordinator of this site? Confirm its status | Arnhem | Netherlands | Recruiting |
| Radiotherapiegroep Coordinator of this site? Confirm its status | Deventer | Netherlands | Recruiting |
| Catharina hospital Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Zuidwest Radiotherapeutisch Instituut (ZRTI) Coordinator of this site? Confirm its status | Flushing | Netherlands | Recruiting |
| UMCG Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Radiotherapy Institute Friesland Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Recruiting |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Not yet recruiting |
| Maastro Clinic Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
| Haga Hospital Coordinator of this site? Confirm its status | The Hague | Netherlands | Not yet recruiting |
| Verbeeten Institute Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.