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Clinical Trial NCT06201078 (PROSTARE) for Local Recurrence of Malignant Tumor of Prostate, Radiotherapy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy (PROSTARE) Phase 2 55 Overall Survival
Clinical Trial NCT06201078 (PROSTARE) is designed to study Treatment for Local Recurrence of Malignant Tumor of Prostate, Radiotherapy. It is a Phase 2 interventional study that is recruiting, having started on 31 July 2023, with plans to enroll 55 participants. Led by Maria Sklodowska-Curie National Research Institute of Oncology, it is expected to complete by 31 December 2029. The latest data from ClinicalTrials.gov was last updated on 13 March 2025.
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 term...
Show MoreDetailed Description
The diagnosis of local recurrence after radiotherapy in patients with prostate cancer is a serious clinical problem. Interventional salvage treatment in the previously irradiated area is difficult with safety issues of special concern. According to the MASTER meta-analysis the effectiveness of various local salvage methods turned out to be comparable in patients with local recurrence after definitive radiotherapy. St...Show More
Official Title
Phase II Study - Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy - PROSTARE (PROstate Cancer STereotActic REirradiation) Trial
Conditions
Local Recurrence of Malignant Tumor of ProstateRadiotherapyPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- PROSTARE
- nio-kb/430-72/23
NCT ID Number
Start Date (Actual)
2023-07-31
Last Update Posted
2025-03-13
Completion Date (Estimated)
2029-12-31
Enrollment (Estimated)
55
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
local recurrence
prostate
radiotherapy
salvage
prostate
radiotherapy
salvage
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSalvage SBRT for locally recurrent prostate cancer after radiotherapy SBRT: 5 x 6.75 Gy (every other day) to the total dose of 33.75 Gy | Stereotactic Body Radiotherapy Salvage SBRT will be performed in three subgroups of patients with local recurrence:
Group A - after conventionally fractionated/moderately hypofractionated definitive radiotherapy; Group B - after prostatectomy and postoperative radiotherapy; Group C - after ultrahypofractionated definitive SBRT
Target volumes:
GTV- tumour visible on MRI and PET-CT; CTV- 1-3 mm margin around GTV PTV- 3 mm around CTV\*
\*- in cas...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Tolerance of salvage SBRT | Assessment of early and late radiation toxicity: Grade ≥ 3 radiation-induced bladder/urethral (GU) and bowel/rectal (GI) adverse events toxicity or other, according to CTCAE criteria | 3 months post-SBRT, 2-years post-SBRT |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Tolerance of salvage SBRT | Rate of moderate or worse early and late radiation toxicity: Grade ≥ 2 radiation-induced bladder/urethral (GU) and bowel/rectal (GI) adverse events toxicity or other, according to CTCAE criteria | 3 months post-SBRT, every 6 months post SBRT up to 3-years post-SBRT |
Biochemical Control | Biochemical Control will be defined as observations without biochemical recurrence defined as PSA concentration: a. \>2 ng/mL above the nadir (according to Phoenix) for groups A and C b. \>0.2 ng/ml (according to AUA) for group B | 3 months post-SBRT, 6 months post SBRT, every 6 months thereafter up to 5-years post-SBRT |
Biochemical Response | Decrease in PSA level below baseline (pre-SBRT) | 3 months post-SBRT, 6 months post-SBRT, every 6 moths thereafter up to 5-years post-SBRT |
Biochemical Failure-Free Survival (BFS) | Biochemical Failure Free Survival (BFS) is defined as the time interval between SBRT and biochemical, local, regional failure, distant metastasis or death irrespective of the cause | 3 months post-SBRT, 6 months post SBRT, every 6 months thereafter up to 5-years post-SBRT |
Metastases-Free Survival | Metastases-Free Survival is the time interval between SBRT and occurrence of distant metastases or death irrespective of the cause | 1-year post SBRT, then annually up to 5-years post-SBRT |
Relapse-Free Survival | Relapse-Free Survival is the time interval between SBRT and occurrence of clinical relapse: local recurrence, regional or distant metastases, start of hormonal therapy, or death irrespective of the cause | 1-year post SBRT, then annually up to 5-years post-SBRT |
Local Control | Local Control is defined as the observations without local failure (within prostate or prostate bed):
1. in-field
2. out-field | 1-year post SBRT, then annually up to 5-years post-SBRT |
Overall Surival | Overall Survival is the time interval between SBRT and patient death irrespective of the cause | 3 months post-SBRT, 6 months post-SBRT, every 6 moths thereafter up to 5-years post-SBRT |
Patients' reported Quality of Life | Evaluation of EORTC QLQ-C30 and PR-25 questionnaires | 2-years post SBRT, 3-years post SBRT |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
Local recurrence of prostate cancer after definitive radiotherapy
- biopsy proven or/and
- Consistent MRI and PET-PSMA results and PSA growth dynamics
Time since primary radiotherapy - at least 2 years
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.
- Polymetastatic dissemination in distant or regional lymph nodes (N1, M1) or oligometastatic dissemination, but not eligible for local forms of metastasis directed therapy (MDT)
- Tumour volume (GTV) > 14 cc
- Poor tolerability of primary radiotherapy (≥G3 toxicity) or persistent late toxicity ≥G2 interfering with re-irradiation
- Severe dysuria before repeated SBRT (e.g., IPSS ≥19)
- Diseases of the distal part of the rectum or anal canal that may affect SBRT tolerance (e.g., anal fissure)
- Previous prostate brachytherapy
- Substantial risk for further urologic interventions (e.g., TURB/TURP)
Maria Sklodowska-Curie National Research Institute of OncologyStudy Central Contact
Contact: Wojciech Majewski, MD, PhD, +48322788001, [email protected]
Contact: Aleksandra Napieralska, MD, PhD, +48322788001, [email protected]
1 Study Locations in 1 Countries
Maria Sklodowska Memorial Research Institute of Oncology, Gliwice, 44-100, Poland
Wojciech Majewski, MD, PhD, Contact, +48322788001, [email protected]
Aleksandra Napieralska, MD, PhD, Contact, +48322788001, [email protected]
Recruiting