Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
MALE
NCT06282588

Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers

Led by Cancer Research Antwerp · Updated on 2026-03-19

493

Participants Needed

9

Research Sites

367 weeks

Total Duration

On this page

Sponsors

C

Cancer Research Antwerp

Lead Sponsor

B

Bayer

Collaborating Sponsor

AI-Summary

What this Trial Is About

This Investigator-initiated, Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) study will be conducted in subjects with high-risk localized or locally advanced prostate cancer (PCa). The study contains both a randomized Phase 3 treatment intensification study, as well as a treatment de-intensification non-randomized Phase 2 study. The aim of the THUNDER study is to improve the outcome of high-risk PCa by improved risk stratification. Novel radiotracers and a genomic classifier (Decipher) will be used to guide treatment decisions, instead of standard imaging which is limited by lower sensitivity and specificity. The hypothesis for the study is that treatment intensification based on a positive PSMA PET/ CT scan or Decipher high score (\> 0.85) improves time to new metastases detected on PSMA PET/ CT in high-risk PCa. In patients who are PSMA PET/ CT negative with a low/ intermediate Decipher score (≤ 0.85), it is hypothesized that treatment de-intensification will improve patient quality of life while maintaining a good oncological outcome. The study will be conducted at multiple centers across Europe. Participation in the study will comprise a screening period, where the screening assessments must be completed before subjects are enrolled and randomized (only for Phase 3 subjects). Eligible, consenting subjects will then undergo treatment according to their assigned study phase and treatment group, to occur over up to 96 weeks (24 months) with a post-treatment follow-up period to monitor safety and efficacy. The study will be closed when 96 events have been registered for the primary endpoint, which is expected to be at 7-8 years from the time of randomization of the first subject.

CONDITIONS

Official Title

Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histopathology-proven prostate cancer
  • High-risk locally advanced disease defined by PSA > 20 ng/mL, or T-stage 3 or 4, or Gleason score 8-10, or clinical N1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Willingness to undergo PSMA PET/CT imaging with or without contrast
  • Willingness to have primary tumor sequenced for Decipher score determination
  • Willingness to undergo standard radiation therapy and long-term androgen deprivation therapy (darolutamide and/or LHRHA)
  • Able and willing to provide written informed consent and comply with all study procedures and follow-up visits
  • Age 18 years or older
  • Able to swallow whole study drug tablets
  • Use of condom during sexual activity while on study drug and for 3 months after last treatment; no sperm donation during treatment and 3 months after
  • Adequate organ function including bone marrow, renal, liver function, and testosterone levels above specified thresholds
Not Eligible

You will not qualify if you...

  • Evidence of metastatic disease outside pelvic lymph nodes on conventional imaging
  • Prostate cancer with predominant non-adenocarcinoma features
  • Prior pelvic radiotherapy
  • Contraindications to pelvic radiotherapy or androgen deprivation therapy
  • Known allergy or contraindication to PSMA PET/CT tracers
  • Prior local prostate cancer therapies such as prostatectomy, high-intensity focused ultrasound, or cryotherapy (except TURP or Millin prostatectomy)
  • Prior systemic therapy for prostate cancer, except ADT started no more than 4 weeks before randomization in certain cases
  • Current use of 5-alpha reductase inhibitors unless stopped at least 2 weeks before enrollment
  • Chronic opioid use for 3 weeks or more (oral) or 7 days or more (non-oral)
  • History of seizure or conditions predisposing to seizures
  • Major surgery within 21 days before enrollment
  • Significant cardiovascular events or conditions within 6 months before enrollment
  • Known gastrointestinal diseases or procedures interfering with drug absorption
  • History of other malignancies within 5 years except certain low-risk cancers
  • Severe concurrent illness or infection that may affect safety or study compliance
  • Sexually active men with women of childbearing potential not willing or able to use effective contraception during and 3 months after treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 9 locations

1

ZAS Sint-Augustinus

Wilrijk, Antwerp, Belgium, 2610

Actively Recruiting

2

AZORG

Aalst, Belgium, 9300

Actively Recruiting

3

AZ Sint-Jan

Bruges, Belgium, 8000

Actively Recruiting

4

Saint Luc

Brussels, Belgium, 1200

Actively Recruiting

5

UZ Gent

Ghent, Belgium, 9000

Actively Recruiting

6

AZ Groeninge

Kortrijk, Belgium, 8500

Actively Recruiting

7

CHU Liège

Liège, Belgium, 4000

Actively Recruiting

8

AZ Delta

Roeselare, Belgium, 8800

Actively Recruiting

9

VITAZ

Sint-Niklaas, Belgium, 9100

Actively Recruiting

Loading map...

Research Team

P

Piet Ost, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here