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Local Recurrence of Malignant Tumor of ProstatePhase 2PROSTARENCT06201078

Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy

A Phase 2 study testing Stereotactic Body Radiotherapy in people with Local Recurrence of Malignant Tumor of Prostate and Radiotherapy, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
What is being tested?
Stereotactic Body Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 sitePoland
Study dates
31 Jul 2023to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wojciech Majewski, MD, PhD contact

+48322788001

wojciech.majewski@gliwice.nio.gov.pl

Aleksandra Napieralska, MD, PhD contact

+48322788001

aleksandra.napieralska@gliwice.nio.gov.pl

Poland1 site, 1 recruiting

  • Maria Sklodowska Memorial Research Institute of Oncology

    Gliwice, 44-100

    Wojciech Majewski, MD, PhD, +48322788001, wojciech.majewski@gliwice.nio.gov.pl

    Aleksandra Napieralska, MD, PhD, +48322788001, aleksandra.napieralska@gliwice.nio.gov.pl

    Recruiting

Other trials in Poland

About this study

Official title: Phase II Study - Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy - PROSTARE (PROstate Cancer STereotActic REirradiation) Trial

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).

Read more

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.

Read the detailed 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. Stereotactic radiotherapy (SBRT) had the best toxicity profile, so this non-invasive treatment may be a suitable alternative to other methods. A particular problem is local recurrences after post-prostatectomy radiotherapy. The data on SBRT in such setting are even more scarce than in the case of relapses after definitive radiotherapy. Still, they show a low percentage of serious adverse events of grade ≥3 and good treatment tolerance.

Considering the own experience with re-irradiation of patients with prostate cancer, it was decided that re-irradiation should be carried out in the form of focal SBRT. With the objective of enhancing the safety and quality of salvage re-irradiation, and a comprehensive evaluation of the efficacy of this treatment it was determined that it should be implemented as a prospective phase II study- PROSTARE (PROstate cancer STereotActic Reirradiation).

The evaluation of the tolerance and effectiveness of stereotactic radiotherapy (SBRT) will be performed in patients with local recurrence after conventionally fractionated/moderately hypofractionated definitive radiotherapy (Group A), ultrahypofractionated definitive SBRT (Group C), or after prostatectomy and postoperative radiotherapy (Group B).

The study will be conducted as a single-centre study. The evaluation of the safety and effectiveness of such treatment could help develop qualification criteria for repeated irradiation. As a consequence, this should allow for the implementation of this form of treatment into radiotherapy protocols and then, in a controlled and safe way, into clinical practice.

The total sample size will comprise 55 patients. The expected recruitment period is 6 years (10 patients per year).

Requirements for reirradiation with SBRT:

  1. Both PET-PSMA and MR of the prostate or prostate bed are required in patients with recurrence after definitive radiotherapy or surgery followed by radiotherapy
  2. Fiducial implantation is not routinely required
  3. Empty rectum and partially empty/partially filled bladder (improved reproducibility)* during treatment planning and during each fraction of stereotactic radiotherapy
  4. Treatment with a linear accelerator is preferred
  5. CBCT must be performed before each fraction of SBRT with verification for tumour location (GTV)**
  6. Focal radiotherapy, i.e., irradiation of only the visible tumour with an appropriate margin
  7. Hormonal treatment is not routinely recommended (according to the ESTRO ACROP consensus) - up to the decision of the attending physician
  • Principles of preparation with laxatives - Bisacodyl is advocated 4-5 hours before SBRT. If the diameter of the rectum on the CT for treatment planning exceeds 4 cm in diameter, the procedure should be repeated after appropriate preparation of the patient.
  • If stereotactic radiotherapy is conducted on the CyberKnife - KV imaging and Tracking verification are required; additionally an assessment of bladder filling in ultrasonography should be performed
Being tested
Stereotactic Body Radiotherapy
Keywords
local recurrence, prostate, radiotherapy, salvage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Body RadiotherapyRadiation

    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 cases in which very high accuracy and reproducibility of SBRT are ensured, and the margin overlaps the rectum and/or bladder, it is possible to reduce the margin from these organs to 1 mm.

    Dose constrains:

    The criteria for limiting the dose in nearby organs are not well-defined for repeated irradiation - the following doses should be aimed:

    • Maximum rectal dose ≤103% of the prescribed dose (optimal ≤100%)
    • Maximum bladder dose ≤105% of the prescribed dose (optimal ≤103%)

    Dose-volume constrains:

    Rectum:

    • D30% <15Gy

    Bladder:

    • D30% < 15 Gy
Study groups in NCT06201078
Study groupRoleWhat they receive
Salvage SBRT for locally recurrent prostate cancer after radiotherapyExperimentalSBRT: 5 x 6.75 Gy (every other day) to the total dose of 33.75 Gy
Receives: Radiation: Stereotactic Body Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 months post-SBRT, 2-years post-SBRT

Secondary outcomes (9)

  1. 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

    Measured: 3 months post-SBRT, every 6 months post SBRT up to 3-years post-SBRT

  2. 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

    Measured: 3 months post-SBRT, 6 months post SBRT, every 6 months thereafter up to 5-years post-SBRT

  3. Biochemical Response

    Decrease in PSA level below baseline (pre-SBRT)

    Measured: 3 months post-SBRT, 6 months post-SBRT, every 6 moths thereafter up to 5-years post-SBRT

  4. 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

    Measured: 3 months post-SBRT, 6 months post SBRT, every 6 months thereafter up to 5-years post-SBRT

  5. Metastases-Free Survival

    Metastases-Free Survival is the time interval between SBRT and occurrence of distant metastases or death irrespective of the cause

    Measured: 1-year post SBRT, then annually up to 5-years post-SBRT

  6. 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

    Measured: 1-year post SBRT, then annually up to 5-years post-SBRT

  7. Local Control

    Local Control is defined as the observations without local failure (within prostate or prostate bed):

    1. in-field
    2. out-field

    Measured: 1-year post SBRT, then annually up to 5-years post-SBRT

  8. Overall Surival

    Overall Survival is the time interval between SBRT and patient death irrespective of the cause

    Measured: 3 months post-SBRT, 6 months post-SBRT, every 6 moths thereafter up to 5-years post-SBRT

  9. Patients' reported Quality of Life

    Evaluation of EORTC QLQ-C30 and PR-25 questionnaires

    Measured: 2-years post SBRT, 3-years post SBRT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2024
  2. Study start31 Jul 2023
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06201078
Sponsor's protocol ID
nio-kb/430-72/23
Acronym
PROSTARE
Status last verified
Mar 2025
First submitted
29 Dec 2023
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Valle LF, Lehrer EJ, Markovic D, Elashoff D, Levin-Epstein R, Karnes RJ, Reiter RE, Rettig M, Calais J, Nickols NG, Dess RT, Spratt DE, Steinberg ML, Nguyen PL, Davis BJ, Zaorsky NG, Kishan AU. A Systematic Review and Meta-analysis of Local Salvage Therapies After Radiotherapy for Prostate Cancer (MASTER). Eur Urol. 2021 Sep;80(3):280-292. doi: 10.1016/j.eururo.2020.11.010. Epub 2020 Dec 11.

    PubMed 33309278

  • Miszczyk M, Kraszkiewicz M, Moll M, Kaminiow K, Sobel S, Dolla L, Wojcieszek P, Rajwa P, Yanagisawa T, Nowicka Z, Shariat SF, Goldner G, Miszczyk L, Majewski W. Long-Term Outcomes of Stereotactic Body Radiotherapy (SBRT) for Intraprostatic Relapse after Definitive Radiotherapy for Prostate Cancer: Patterns of Failure and Association between Volume of Irradiation and Late Toxicity. Cancers (Basel). 2023 Feb 13;15(4):1180. doi: 10.3390/cancers15041180.

    PubMed 36831523

  • Jereczek-Fossa BA, Marvaso G, Zaffaroni M, Gugliandolo SG, Zerini D, Corso F, Gandini S, Alongi F, Bossi A, Cornford P, De Bari B, Fonteyne V, Hoskin P, Pieters BR, Tree AC, Arcangeli S, Fuller DB, Franzese C, Hannoun-Levi JM, Janoray G, Kerkmeijer L, Kwok Y, Livi L, Loi M, Miralbell R, Pasquier D, Pinkawa M, Scher N, Scorsetti M, Shelan M, Toledano A, van As N, Vavassori A, Zilli T, Pepa M, Ost P; on the behalf of the European Society for Radiotherapy, Oncology Advisory Committee on Radiation Oncology Practice (ESTRO ACROP). Salvage stereotactic body radiotherapy (SBRT) for intraprostatic relapse after prostate cancer radiotherapy: An ESTRO ACROP Delphi consensus. Cancer Treat Rev. 2021 Jul;98:102206. doi: 10.1016/j.ctrv.2021.102206. Epub 2021 Apr 20.

    PubMed 33965893

  • Archer P, Marvaso G, Detti B, Colombo F, Francolini G, Vandendorpe B, Thananayagam MA, Baty M, De Crevoisier R, Alongi F, Nicosia L, Scher N, Toledano A, Di Muzio N, Fodor A, Zilli T, Franzese C, Scorsetti M, Shelan M, Triggiani L, Aymes E, Le Deley MC, Jereczek-Fossa BA, Pasquier D. Salvage Stereotactic Reirradiation for Local Recurrence in the Prostatic Bed After Prostatectomy: A Retrospective Multicenter Study. Eur Urol Oncol. 2023 Jun;6(3):303-310. doi: 10.1016/j.euo.2023.03.005. Epub 2023 Apr 1.

    PubMed 37012102

  • Schroder C, Tang H, Windisch P, Zwahlen DR, Buchali A, Vu E, Bostel T, Sprave T, Zilli T, Murthy V, Forster R. Stereotactic Radiotherapy after Radical Prostatectomy in Patients with Prostate Cancer in the Adjuvant or Salvage Setting: A Systematic Review. Cancers (Basel). 2022 Jan 29;14(3):696. doi: 10.3390/cancers14030696.

    PubMed 35158961

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stereotactic Body Radiotherapy in people with Local Recurrence of Malignant Tumor of Prostate and Radiotherapy, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wojciech Majewski, MD, PhD (+48322788001, wojciech.majewski@gliwice.nio.gov.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerance of salvage SBRT (time frame: 3 months post-SBRT, 2-years post-SBRT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06201078, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.

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