Stereotactic Focal Radiotherapy as an Alternative Treatment to Active Surveillance for Low and Intermediate Risk Prostate Cancer

NCT07152067 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: 2025/176B7072025000023
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

Brief Summary

\*Rationale : Active surveillance of prostate cancer helps to avoid the morbidity associated with curative radical prostatectomy /radiotherapy in patients with early stage disease. However, at 5 years and 15 years, respectively 35 % and nearly 50 % of patients require rescue interventional treatments. Numerous Phase II trials have reported using focal treatments (focused on the macroscopic tumor only while not involving the whole prostatic gland) in order to reduce the morbidity due to recurrence as well as the high anxiety rates under observation only. Stereotactic radiotherapy (highly focused radiotherapy technic to reduce the risk of side effects) is being proposed in the same way as it does not require any anaesthesia, as opposed to all the other focal methods. The purpose of this trial is to evaluate whether focal stereotactic radiotherapy treatments could reduce the rate of rescue treatments among patients eligible to an active surveillance program at first.

• Major Inclusion Criteria :
• 1\. Early stage prostate adenocarcinoma (CAPRA score ≤ 5)
• 2\. No major urinary problems
• 3\. Active Surveillance possible
• Major Exclusion Criteria :
• 1\. Age at diagnosis \< 50 years
• 8\. Androgen-deprivation therapy
• 9\. Any cancer within the last 5 years except skin basocellular carcinoma or any uncontrolled cancer
• Trial : Phase II randomized trial comparing Stereotactic Radiation Therapy focused on the macroscopic tumor or Active Surveillance as the control arm.
• Main objective : to compare the rescue treatment rates between the two arms

Conditions

Macroscopic Tumor Visualized at MRI; Tumor Size Allowing Partial Prostate Treatment Volume; CAPRA SCORE ≤5

Keywords

radiosurgery; focal treatment; early prostate cancer; active surveillance; Phase II randomized study; stereotactic radiotherapy; SBRT; quality of life

Outcome Measures

Primary Outcomes (1)

• Rescue treatment performed or not

  Rescue treatment performed due to: 1\. Recurrence - evolution (including at least one of these criteria) : 1a. Any pathologic overscoring shift on biopsies examination 1b. Any PSA doubling time \< 9 months 1c. Any doubling volume of the initial disease at MRI or appearance of a new prostatic lesion PIRADS ≥4 1d. Regional or distant dissemination 2. Patient's personal decision or tumor board decision

  5 years from the enrollment to the last follow up exams

Secondary Outcomes (5)

• Clinical disease free survival

  5 years

• International Prostate Symptom Score (IPSS)

  5 years

• International Consultation on Incontinence Questionnaire (ICIQ).

  5 years

• International Index of Erectile Function - 5 item version (IIEF5)

  5 years

• Hospital Anxiety and Depression Scale (HADS)

  5 years

Study Arms (2)

Active Surveillance

NO INTERVENTION

Active surveillance involving MRI, follow-up biopsies and PET PSMA exams

Focal stereotactic radiation treatment

EXPERIMENTAL

Focal radiation treatment followed by MRI, prostate biopsies and PET PSMA follow up exams

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

SBRT to the macroscopic prostate tumor component defined at MRI

Also known as: Focal stereotactic radiation treatment

Focal stereotactic radiation treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a. Localized prostate adenocarcinoma CAPRA score ≤ 5. This lesion is considered the Index lesion
• b. Macroscopic tumor PIRADS score \>4 on multiparametric MRI
• c. The biopsies must be pathologic in or in the direct vicinity (the same prostatic zone defined as a quarter volume of the prostate (PZ)) of the MRI pathologic nodule
• e. The lesion can be plurifocal in a same intent to treat PZ
• f. WHO Performance Status 0-1
• g. No major urinary symptoms with IPSS score ≤15 and urinary continence ICIQ score =0
• h. Patient is candidate for AS

You may not qualify if:

• a. Age at diagnosis \< 50 years
• b. Time between initial diagnostic biopsies and randomization \> 4 months, or radiation therapy initiation \> 6 months
• c. Cribriform or Intraductal histologic components
• d. Gleason Score ≥7 (3+4)-ISUP Grade 2 biopsy outside the intent to treat PZ
• e. Multicentric pathologic MRI (PIRADS ≥4) outside a same PZ
• f. Initial PSA \> 20 ng/ml
• g. Regional pathologic nodes or metastases
• h. Androgen-deprivation therapy
• i. Any cancer within the last 5 years except skin basocellular carcinoma or any uncontrolled cancer
• j. Urethral stenosis
• k. Recurrent prostatitis (at least 3 episodes within the last 3 years)
• l. Any inflammatory collagen disease.
• m. Contraindication to repeated prostatic biopsies or MRI

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead

Study Sites (2)

Vivalia Hospitals

Arlon, 6700, Belgium

Location

University Hospital Liège

Liège, 4000, Belgium

Location

Related Publications (4)

• Nguyen PV, Donneaux B, Louis C, Bodgal Z, Philippi S, Biver S, Frederick B, Harze L, Lasar Y, Vogin G, Nickers P. Stereotactic focal radiotherapy as an alternative treatment for low-risk prostate cancer: Results of a single-arm monocenter Phase-II trial. Front Oncol. 2023 Apr 6;13:1143716. doi: 10.3389/fonc.2023.1143716. eCollection 2023.

  PMID: 37091187 BACKGROUND

• Newcomb LF, Schenk JM, Zheng Y, Liu M, Zhu K, Brooks JD, Carroll PR, Dash A, de la Calle CM, Ellis WJ, Filson CP, Gleave ME, Liss MA, Martin F, McKenney JK, Morgan TM, Tretiakova MS, Wagner AA, Nelson PS, Lin DW. Long-Term Outcomes in Patients Using Protocol-Directed Active Surveillance for Prostate Cancer. JAMA. 2024 Jun 25;331(24):2084-2093. doi: 10.1001/jama.2024.6695.

  PMID: 38814624 BACKGROUND

• Hopstaken JS, Bomers JGR, Sedelaar MJP, Valerio M, Futterer JJ, Rovers MM. An Updated Systematic Review on Focal Therapy in Localized Prostate Cancer: What Has Changed over the Past 5 Years? Eur Urol. 2022 Jan;81(1):5-33. doi: 10.1016/j.eururo.2021.08.005. Epub 2021 Sep 4.

  PMID: 34489140 BACKGROUND

• Hamdy FC, Donovan JL, Lane JA, Metcalfe C, Davis M, Turner EL, Martin RM, Young GJ, Walsh EI, Bryant RJ, Bollina P, Doble A, Doherty A, Gillatt D, Gnanapragasam V, Hughes O, Kockelbergh R, Kynaston H, Paul A, Paez E, Powell P, Rosario DJ, Rowe E, Mason M, Catto JWF, Peters TJ, Oxley J, Williams NJ, Staffurth J, Neal DE; ProtecT Study Group. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2023 Apr 27;388(17):1547-1558. doi: 10.1056/NEJMoa2214122. Epub 2023 Mar 11.

  PMID: 36912538 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philippe Nickers, MD, PhD

  University Hospital Liège, Belgium

  PRINCIPAL INVESTIGATOR

• Mareva Lamande, MD

  University Hospital Liège, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mareva Lamande, MD

CONTACT

+3243233903; mareva.lamande@chuliege.be

Sandra Tonneau, Secretary

CONTACT

+3243237596; stonneau@chuliege.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Patients will be randomized between active surveillance or stereotactic radiation focused on the Index prostatic lesion visualized at MRI exams

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: September 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2033
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)