NCT04302454Active, not recruitingPhase 3
Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy
Source: ClinicalTrials.gov · Last updated 4 Apr 2025
Brief summary (registry, in English)
The overall aim of this project is to test the hypothesis that the addition of ADT to metastasis-directed radiotherapy (MDRT) in well-selected PCa patients with oligo-metastatic disease prolongs the metastases progression-free survival (MPFS) compared to MDRT alone.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 6 Mar 2020
- Start date
- 19 Mar 2020
- Primary completion date
- 21 Oct 2027
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Prostate cancer
- NCT number
- NCT04302454
- EU CT number
- 2024-511252-41-00
- EudraCT number
- 2019-003177-26
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 280
- From 19 Mar 2020 to the primary completion date, 21 Oct 2027
- 10 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
- ADT or chemotherapy for recurrent PCa.
- Painful metastases needed pain medication (\> level 1 pain medication) .
Other illness
- Invasive active cancers other than superficial non-melanoma skin cancers.
Other
- Visceral metastases.
- PSA ≥ 10 ng/ml.
- PSA-doubling time ≤ 3 months.
- Testosterone \< 1.7 nmol/l
- 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
- Histologically proven initial diagnosis of adenocarcinoma of the Prostate.
- Biochemical recurrence of prostate cancer following primary local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant salvage radiotherapy) according to the EAU guidelines 2018. BCR after surgery: PSA \> 0.1ng/ml. BCR after radiotherapy: PSA nadir +2 ng/ml or 3 consequent rises in PSA level (after exclusion of possible bounce effect).
- Minimal 1 lesion and maximum 4 lesions (bone + lymph nodes) in total, without evidence of visceral metastases.
- Nodal relapse (N1) in the pelvis on PSMA-PET/CT with a maximum of 4 positive lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation.
- Nodal relapse (M1a) on PSMA-PET/CT above the aortic bifurcation with a maximum of 3 positive lymph nodes.
- Bone relapse on PSMA-PET/CT with a maximum of 3 lesions.
- Combination of a, b, c with a maximum of 4 metastases.
- Age \> 18 years.
- Recent PSMA-PET/CT scan within 60 days prior to randomization.
- PSA \< 10 ng/ml.
- In case of chronic use of finasteride the PSA value should be \< 5 ng/ml.
- WHO performance state 0-2.
- Signed informed consent prior to registration/randomization.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Academic Medical Center at the University of Amsterdam Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Radiotherapiegroep Coordinator of this site? Confirm its status | Arnhem | Netherlands | Active, not recruiting |
| Catharina Ziekenhuis Stichting Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Active, not recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Active, not recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Active, not recruiting |
| Maastro Coordinator of this site? Confirm its status | Maastricht | Netherlands | Active, not recruiting |
| Radboud universitair medisch centrum / RADBOUDUMC Coordinator of this site? Confirm its status | Nijmen | Netherlands | Active, not recruiting |
| Haga Hospital Coordinator of this site? Confirm its status | 's-Gravenhage | Netherlands | Active, not recruiting |
| Stichting Dr. Bernard Verbeeten Instituut Coordinator of this site? Confirm its status | Tilburg | Netherlands | Active, not recruiting |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Active, not recruiting |
Related publications
- Five-Year Outcomes After Prostate-Specific Membrane Antigen PET/CT-Guided Salvage Radiotherapy Following Radical Prostatectomy.J Natl Compr Canc Netw · 2026 · PMID 41698328
This page is information, not medical advice. Discuss any trial with your doctor.