Treatment for recurrent prostate cancer with metastases
a New Spark in Treating Oligorecurrent Prostate Cancer: Adding Systemic Treatment to Stereotactic Body Radiotherapy or Metastasectomy: Key to Long-lasting Event-free Survival?
This study is testing whether combining hormone therapy with targeted radiation or surgery can help men with recurrent prostate cancer live longer without their cancer spreading.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 873 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05352178 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining short-term androgen deprivation therapy (ADT) with metastasis-directed therapy (MDT) in patients with oligorecurrent hormone-sensitive prostate cancer. Participants will receive stereotactic body radiation therapy (SBRT) or surgery to target metastases, alongside ADT and androgen receptor targeted therapy. The goal is to determine if this combination can significantly prolong the time patients remain free from metastatic progression and castration-resistant prostate cancer. The study aims to improve patient outcomes by delaying the need for palliative androgen deprivation therapy and its associated side effects.
Who should consider this trial
Good fit: Ideal candidates are adult men aged 18 and older with a confirmed diagnosis of oligorecurrent prostate cancer and a maximum of 5 extracranial metastases.
Not a fit: Patients with extensive metastatic disease beyond 5 spots or those with uncontrolled primary tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly extend the time patients live without metastatic progression and improve overall survival rates.
How similar studies have performed: Previous studies on metastasis-directed therapy have shown promising results, indicating that this approach may be effective, although the specific combination being tested here is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically proven initial diagnosis of prostate adenocarcinoma * Priory treated and controlled primary tumor * Biochemical recurrence defined by prostate-specific antigen (PSA) values \>0,2 ng/ml (i.e., two consecutive increases) following radical prostatectomy + postoperative radiotherapy and a PSA value of 2 ng/ml above the nadir after high-dose RT. * Oligorecurrent disease defined as a maximum of 5 extracranial metastases in any organ, diagnosed on PSMA PET-CT or PSMA PET-MRI reported according to the E-PSMA consensus guidelines for interpretation of PSMA-PET (26). Nodal (N1) disease can be included only when accompanied by M1a-c disease, provided that the total number of spots does not exceed 5. * Serum testosterone level within normal range. * WHO performance 0-2 * Age \>= 18 years old * Absence of psychological, sociological or geographical condition potentially hampering compliance with study protocol. * Patients must be presented at the multidisciplinary board meeting and the inclusion in the trial needs approval by this board. * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures * 2\. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner. Exclusion Criteria: * Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol * Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial * Participation in an interventional Trial with an investigational medicinal product (IMP) or device * Serum testosterone level at castration level. * PSA rise while on active treatment (LHRH-agonist, LHRH antagonist, anti-androgen, maximal androgen blockade, oestrogen) * Presence of poly-metastatic disease, defined as more than 5 metastatic lesions. * Active malignancy other than prostate cancer that could potentially interfere with the interpretation of this trial. * Previous treatments (RT, surgery) or comorbidities rendering new treatment with SBRT impossible. * Contra indications for intake of enzalutamide (seizure or any condition that may predispose to seizure; significant cardiovascular disease within the last three months including myocardial infarction, unstable angina, congestive heart failure, ongoing arrythmias of grade \> 2 or a thromboembolic event). * Not able to understand the treatment protocol or sign informed consent.
Where this trial is running
Leuven
- University Hospitals Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Kato Rans, MD
- Email: kato.rans@uzleuven.be
- Phone: 003216340110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.