Image-guided Focal Dose Escalation- Primary pc Treated With Primary External Beam Hypofract.Stereotactic rt

NCT06330909 | Recruiting DMC

• 2 other identifiers: P003103DRKS00022915
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief Summary

Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time and by (ii) enabling a safe delivery of high RT doses. Several studies proposed a dose-response relationship for patients with primary prostate cancer (PCa) and especially in patients with high-risk features a dose escalation should lead to improved tumor control. In parallel to the improvements in RT techniques, diagnostic imaging techniques like multiparametric magnetic resonance imaging (mpMRI) and positron-emission tomography (PET) evolved and enable an accurate depiction of the intraprostatic tumor mass for the first time. The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts. This novel concept will be compared with moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide. We suspect an increase in relapse-free survival (RFS) and we will also assess quality of life in order to detect potential changes.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; HypoFocal; HypoFocal-SBRT

Outcome Measures

Primary Outcomes (1)

• Relapse free survival

  Primary endpoint is relapse free survival (RFS), defined as time from randomization to relapse or death. Relapse free survival times will be censored at the time see last alive without relapse. Analysis will be conducted after finalization of the study.

  7 years

Secondary Outcomes (10)

• Time to local failure after randomization

  7 years

• Metastatic free survival after randomization

  7 years

• Overall (OS) and prostate cancer specific (PCSS) survival after randomization

  7 years

• Time to biochemical failure (phoenix definition) after randomization

  7 years

• Patient reported acute quality of life (QOL) - Expanded Prostate Index Composite-26 (EPIC-26)

  at months 3 and 6 after randomization

Study Arms (2)

Arm A - IMRT/IGRT/SBRT

EXPERIMENTAL

Prostate and seminal vesicles RT with 30 Gy in 6 Gy / fraction; prostate RT with 35 Gy in 7 Gy / fraction including a simultaneous integrated boost (SIB) on the intraprostatic tumour mass (ITM) with 40- 42 Gy in 8 - 8.4 Gy / fraction. If the boost volume is ≥10 ml and/ or ≥ 1/3 of the prostate, the SIB on the ITM has to be restrained to 40 Gy in 8 Gy / fraction. SBRT will be performed twice a week, with at least 2 days between two RT fractions, 5 fractions in 3 weeks (technique: IMRT/IGRT/SBRT).

Radiation: Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT

Arm B - IMRT/IGRT

ACTIVE COMPARATOR

Prostate and seminal vesicles RT with 46.4 Gy in 2.32 Gy per fraction, prostate RT with 60 and 62 Gy in 3 and 3.1 Gy per fraction for unfavorable intermediate-risk and high-risk patients, respectively, 20 fractions, 5 fractions /week, (technique: IMRT/IGRT).

Radiation: Radiotherapy (RT) Arm B - IMRT/IGRT

Interventions

Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT RADIATION

technique: IMRT/IGRT/SBRT The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts.

Also known as: Intensity modulated radiotherapy (IMRT), Image guided radiotherapy (IGRT), Stereotactic Body Radiation Therapy (SBRT)

Arm A - IMRT/IGRT/SBRT

Radiotherapy (RT) Arm B - IMRT/IGRT RADIATION

technique: IMRT/IGRT Moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide.

Also known as: Intensity modulated radiotherapy (IMRT), Image guided radiotherapy (IGRT)

Arm B - IMRT/IGRT

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old)
• Primary localized PCa (cN0 and cM0 in mpMRI and PSMA PET):
• high- or very high-risk according to NCCN v2.2021 (see 20.3) OR
• unfavorable intermediate-risk disease according to NCCN v2.2021 (see 20.3)
• Signed, written informed consent for HypoFocal-SBRT study
• Age \> 18 years
• Previously conducted PSMA-PET/CT and mpMRI scans or PSMA-PET/MR, fulfilling standard requirements for PCa (see also 6.5)
• ECOG Performance score 0 or 1
• IPSS Score ≤15
• Prostate volume ≤75 ml at RT planning

You may not qualify if:

• Evidence of neuroendocrine tumor cells
• Prior radiotherapy to the prostate or pelvis
• Prior radical prostatectomy
• Prior focal therapy approaches to the prostate
• Time gap between the beginning of ADT and conduction of mpMRI and PSMA PET scans is \>1 month
• Radiologically suspicious or pathologically confirmed lymph node involvement (cN+) in mpMRI and/or PSMA PET/CT
• Evidence of metastatic disease (cM+) in mpMRI and/or PSMA PET/CT
• Evidence of cT4 disease in mpMRI or PSMA PET/CT
• PSA \>30 ng/ml prior to starting ADT
• Expected patient survival \<5 years
• Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts
• Contraindication to undergo a mpMRI scan
• Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization
• Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia
• Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival

Sponsors & Collaborators

• University Hospital Freiburg: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (1)

Medical Center - University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy; Radiotherapy, Intensity-Modulated; Radiotherapy, Image-Guided; 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)

Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anca-Ligia Grosu, Prof.

  Medical Center- University of Freiburg

  STUDY CHAIR

Central Study Contacts

Sabine Schneider-Fuchs, DR

CONTACT

+4976127074040; sabine.schneider-fuchs@uniklinik-freiburg.de

Sonja Adebahr, MD

CONTACT

+4976127095200; sonja.adebahr@uniklinik-freiburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: This is a prospective, randomized two arm phase III multicentre trial comparing image-guided focal dose escalation using SBRT in patients with primary PCa treated with primary external beam hypofractionated radiation therapy. Patients will be randomized to either arm A (experimental intervention) or arm B (control intervention).

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: March 26, 2024
• Study Start: August 18, 2022
• Primary Completion: August 1, 2025
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)