NCT04642027 PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy
| NCT ID | NCT04642027 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Medical Center Groningen |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 538 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2029-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 538 participants in total. It began in 2020-09-01 with a primary completion date of 2029-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
S. Aluwini, Dr.
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT04642027 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04642027 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 538 participants.
Is NCT04642027 currently recruiting?
Yes, NCT04642027 is actively recruiting participants. Contact the research team at f.h.e.staal@umcg.nl for enrollment information.
Where is the NCT04642027 trial being conducted?
This trial is being conducted at Arnhem, Netherlands, Nijmegen, Netherlands, Maastricht, Netherlands, Eindhoven, Netherlands and 9 additional locations.
Who is sponsoring the NCT04642027 clinical trial?
NCT04642027 is sponsored by University Medical Center Groningen. The principal investigator is S. Aluwini, Dr. at University Medical Center Groningen. The trial plans to enroll 538 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.