Protons Vs. Photons for High-risk Prostate Cancer

NCT05350475 | Recruiting DMC

• 1 other identifier: 1-10-72-290-21
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to assess late gastro-intestinal side-effects comparing proton therapy to photon therapy in high-risk prostate cancer patients receiving whole pelvic irradiation.

Conditions

Prostate Cancer; Radiotherapy Side Effect

Keywords

Proton Therapy; High Risk; Intensity Modulated Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26)

  Patient Reported Outcome The investigators aim at reducing gastro-intestinal toxicity grad 2 more than 5 points, which is considered clinically significant, measured by mean points, which is considered clinically significant.

  2 years

Secondary Outcomes (11)

• Late Genito-urinary (GU) and sexual toxicity ≥ 2 grade at year 2 and 5 compared to baseline (Common Terminology Criteria for Adverse Events (CTCAE) toxicity score (CTC_AE 5.0)

  5 years

• Late GU and sexual toxicity at year 2, 5 and 10 compared to baseline (EPIC-26)

  10 years

• Late GI toxicity at year 5 compared to baseline (EPIC-26)

  5 years

• Acute GI at start, at the end of therapy and week 12 compared to baseline (EPIC-26)

  12 weeks

• Acute GI at start, at the end of therapy and week 12 compared to baseline (CTC_AEv.5.0)

  12 weeks

Study Arms (2)

Proton therapy

EXPERIMENTAL

Radiation: Proton Therapy 78 Gray (Gy) in 39 fractions with 56 Gy to the Pelvic Lymph Nodes (LN), 5 days a week. Androgen Deprivation Therapy (ADT) for three years, starting 3 months before Proton Therapy.

Radiation: Proton therapy

Photon Therapy

ACTIVE COMPARATOR

Radiation: Photon Therapy 78 Gy in 39 fractions with 56 Gy to the pelvic LN, 5 days a week. ADT for three years, starting 3 months before Photon Therapy.

Radiation: Photon therapy

Interventions

Proton therapy RADIATION

Patients in the experimental arm will receive proton therapy within the same dose and fraction schedule as patients receiving photon therapy, which is standard treatment.

Proton therapy

Photon therapy RADIATION

Patients in the photon arm will receive standard treatment with photon therapy.

Photon Therapy

Eligibility Criteria

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

You may qualify if:

• Histologically verified localized/locally advanced prostate cancer T1-3bN0-1M0 (TNM 8th edition). A clinical T4 is allowed if it is because of invasion into the bladder neck.
• Adenocarcinoma (mixed histology allowed as long as the adenocarcinoma component comprise more than 50%)
• Indication for elective lymph node irradiation
• PSA \< 100 ng/mL
• Age ≥18 years
• Performance status 0-1
• Life expectancy ≥ 10 years
• Able to understand and comply with the treatment protocol
• No evidence of inflammatory bowel disease Ability to adhere to procedures for study and follow-up
• Signed informed consent to participate in the study

You may not qualify if:

• No previous treatment for prostate cancer
• Hip-prostheses
• Other metal devices in the pelvic region (except fiducials)
• Previous major abdominal/rectal surgery
• Any other malignancy the last five years except for basal or squamous cell skin cancer
• Unable to understand patient information or comply with treatment and safety instructions
• Unable to read and understand patient information due to cognitive disabilities or language (Danish).

Sponsors & Collaborators

• University of Aarhus: lead
• Rigshospitalet, Denmark: collaborator
• Odense University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Sygehus Lillebaelt: collaborator
• Herlev and Gentofte Hospital: collaborator
• Naestved Hospital: collaborator

Study Sites (7)

Dept. of Oncology, Rigshospitalet, Denmark

Copenhagen, Capital Region, Denmark

NOT YET RECRUITING

Department of Oncology, Copenhagen University Hospital Herlev

Herlev, Capital Region, DK-2730 Herlev, Denmark

RECRUITING

Department of Oncology, Aarhus University Hospital

Aarhus, Central Region, 8200, Denmark

RECRUITING

Dept. of Oncology, Aalborg University Hospital

Aalborg, Region North, Denmark

RECRUITING

Dept. of Oncology, Zealand University Hospital, Denmark

Næstved, Region Sjælland, Denmark

RECRUITING

Department of Oncology, Odense University Hospital

Odense, Region South, 5000, Denmark

NOT YET RECRUITING

Department of Oncology, Vejle Hospital, Denmark

Vejle, Region South, Denmark

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Radiation Injuries

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Stine Elleberg Petersen, MD, Ph.D

  Danish Centre for Particle Therapy, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stine Elleberg Petersen, MD, Ph.D

CONTACT

+4529474408; stinpete@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized phase 3 study, randomizing 1:1 between photon vs. proton therapy for prostate cancer patients with high risk disease

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 28, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2037
• Last Updated: March 7, 2025

Record last verified: 2024-12

Locations

DK (7)