NCT06201078 Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy
| NCT ID | NCT06201078 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Maria Sklodowska-Curie National Research Institute of Oncology |
| Condition | Local Recurrence of Malignant Tumor of Prostate |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2023-07-31 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 55 participants in total. It began in 2023-07-31 with a primary completion date of 2029-12-31.
⚠ 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
The goal of this clinical study is to evaluate the toxicity and efficacy of re-irradiation using focal stereotactic body radiotherapy (SBRT) in patients with local recurrence of prostate cancer after definitive or post-operative radiotherapy. The main question is the tolerance of such treatment, concerning the incidence of Grade ≥ 2 and Grade ≥ 3 GU and GI toxicity. Also the efficacy of SBRT will be measured in terms of Biochemical Control with other secondary endpoints which include: Biochemical Response, Biochemical Failure-Free Survival, Metastases-Free Survival, Relapse-Free Survial, Local Control, Overall Survival and patients' reported tolerance measured with Quality of Life questionnaires (QoL C-30 and PR-25). The evaluation of the tolerance and effectiveness of stereotactic radiotherapy (SBRT) will be performed in 3 subgroups: in patients with local recurrence after conventionally fractionated/moderately hypofractionated definitive radiotherapy (Group A) or ultrahypofractionated definitive SBRT (Group C) or after prostatectomy and post-operative radiotherapy (Group B). The study group is planned to include 55 patients.
Eligibility Criteria
Inclusion Criteria: 1. Local recurrence of prostate cancer after definitive radiotherapy 1. biopsy proven or/and 2. Consistent MRI and PET-PSMA results and PSA growth dynamics 2. Time since primary radiotherapy - at least 2 years 3. Good performance status (ZUBROD 0-1) * If the results of the MRI and PET PSMA are inconsistent, and if there is no technical possibility of performing an MRI biopsy, the treatment is acceptable, but repeated imaging (PET or MRI) should be performed to assess the dynamics of the recurrence. Exclusion Criteria: 1. Polymetastatic dissemination in distant or regional lymph nodes (N1, M1) or oligometastatic dissemination, but not eligible for local forms of metastasis directed therapy (MDT) 2. Tumour volume (GTV) \> 14 cc 3. Poor tolerability of primary radiotherapy (≥G3 toxicity) or persistent late toxicity ≥G2 interfering with re-irradiation 4. Severe dysuria before repeated SBRT (e.g., IPSS ≥19) 5. Diseases of the distal part of the rectum or anal canal that may affect SBRT tolerance (e.g., anal fissure) 6. Previous prostate brachytherapy 7. Substantial risk for further urologic interventions (e.g., TURB/TURP)
Contact & Investigator
Wojciech Majewski, MD, PhD
PRINCIPAL INVESTIGATOR
Maria Sklodowska Curie Memorial Research Institute of Oncology
Frequently Asked Questions
Who can join the NCT06201078 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Local Recurrence of Malignant Tumor of Prostate. 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 NCT06201078 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06201078 currently recruiting?
Yes, NCT06201078 is actively recruiting participants. Contact the research team at wojciech.majewski@gliwice.nio.gov.pl for enrollment information.
Where is the NCT06201078 trial being conducted?
This trial is being conducted at Gliwice, Poland.
Who is sponsoring the NCT06201078 clinical trial?
NCT06201078 is sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. The principal investigator is Wojciech Majewski, MD, PhD at Maria Sklodowska Curie Memorial Research Institute of Oncology. The trial plans to enroll 55 participants.