A Phase 2 interventional study of Metastasis directed radiotherapy in Prostate Cancer (Adenocarcinoma), OligoProgressive Metastatic Disease and Castration Resistant Metastatic Prostate Cancer, sponsored by University Medical Center Groningen. Recruiting at 2 sites in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by University Medical Center Groningen · Phase 2, Interventional, and Treatment
In patients with metastatic prostate cancer (PCa) who receive androgen deprivation therapy (ADT), the sensitivity to castration will eventually disappear due to the selection of castration-refractory clones. This will lead to the stage of metastatic castration-refractory prostate can-cer (mCRPC), which is incurable and results in a median overall survival of 2-3 years.
Treatment options for patients with mCRPC include several systemic agents, such as andro-gen receptor-targeted agents (ARTA), chemotherapy (docetaxel, cabazitaxel) and bone-targeting agents (radium- 223). Clinical progression and, to a lesser extent, biochemical pro-gression traditionally imply a switch to the next line systemic treatment (NEST). Within patients with mCRPC, there is a subgroup showing oligo-progression, defined as the progression of up to 3 lesions, including both metastatic and/or local relapse. Oligoprogression reflects a heterogeneous treatment response, which, in turn, reflects the heterogeneity of the clonogenic cells that give rise to mCRPC. Retrospective studies suggest that metastasis-directed radiotherapy (MDRT) to these oligoprogressive lesions delayed the need for NEST. Recently, promising results were published on the use of MDRT in the oligopro-gressive mCRPC (omCRPC) setting, with a NEST-free survival (NEST-FS) of 21 months in well selected patients. Currently, in The Netherlands, patients with omCRPC are frequently referred and treated with MDRT, but a clear treatment protocol and inclusion/selection criteria are missing. Moreover, the exact benefit of MDRT in patients with omCRPC remains unclear, as prospective evi-dence for MDRT in omCRPC is lacking.
The primary aim of this study is to test the hypothesis that the addition of MDRT to standard of care (ADT or ADT + chemotherapy or ARTA) in well-selected PCa patients with oligometastatic progressive disease, defined on PSMA PET, prolongs the radiological progression-free survival (rPFS) and postpones the start of next line systemic therapy (NEST). Patients included in this study already have an indication to start NEST, and any delay introduced by adding MDRT will result in a net benefit for the patients.
Primary objectives include: Postponement of the start of next line systemic treatment (NEST), and enhancement of the radiological progression-free survival (rPFS) In this single arm multicenter prospective phase II trial, we aim to include 35 patients with omCRPC (1-3 metastases and/or local recurrence) who will be treated with MDRT to the visible progressive lesions (up to max of 3). Progression is based on PSMA PET.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 35 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
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Exclusion Criteria:
Patients included in the study with a post prostatectomy local recurrence on the PSMA PET with up to 3 oligometastases will be treated preferably with SBRT to all oligometastatic lesions and to the local recurrence in prostate bed
Radiation: Metastasis directed radiotherapy
According to guidelines, in the case of oligoprogression next line systemic treatment is recommended. This study investigates the potential delay of NEST and rPFS by MDRT.
NEST-FS
Next line systemic treatment free survival
Time frame: 6, 12-and 24-months
rPFS
radiologic progression free survival
Time frame: 6, 12-and 24-months
Quality of Life (QoL)
Evaluated using the EORTC QLQ-C30 for health related QoL.
Time frame: baseline, 6 months, 12 months, 24 months
Biochemical progression
after an initial decline in PSA: the time from start of therapy to first PSA increase that is ≥25% and ≥ 2 ng/ml above the nadir, and which is confirmed by a second value ≥3 weeks later.
Time frame: From date of randomization until the date of first documented biochmical progression, assessed up to 36 months
Overall survival (OS)
Overall survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Quality of life (QoL)
EORTC PR-25 for prostate symptom specific QoL.
Time frame: baseline, 6 months, 12 months, 24 months
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 RT
Acute grade ≥ 2 gastrointestinal toxicity
Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
Time frame: Up to 3 months after completion of the RT
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 RT
Acute grade ≥ 2 genitourinary toxicities
Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
Time frame: Up to 3 months after completion of the RT
Late grade ≥ 2 genitourinary toxicities
Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
Time frame: Up to 2 years after completion of the RT
Late grade ≥ 2 genitourinary toxicity
Using physician-reported score (CTCAE 5.0 toxicity score).
Time frame: Up to 2 years after completion of the RT
Late grade ≥ 2 gastrointestinal toxicity
As assessed using physician-reported score (CTCAE 5.0 toxicity score).
Time frame: Up to 2 years after completion of the RT
Late grade ≥ 2 gastrointestinal toxicity
Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
Time frame: Up to 2 years after completion of the RT
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