Protons vs. Photons for High-risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Lymph Node Radiation Therapy With Integrated Boost to Prostate for High-risk Prostate Cancer A Randomized Phase 3 Trial Comparing Photons vs. Protons

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05350475
• Other study ID #: 1-10-72-290-21
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 1, 2037

Study information

• Verified date: March 2022
• Source: University of Aarhus
• Contact: Lise Bentzen
• Phone: +45 78 45 64 00
• Email: lise.b[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Proton therapy (PT) is a radiation technique with possibility to spare normal pelvic organs: bladder, rectum and bowel for PC patients. Most PC patients treated with PT receive PT to the prostate gland alone. With PT, we aim to examine PC patients in high risk with both lymph node and prostate treatment will experience less late side effects with PT compared to photon treatment. The investigators propose a national open-labelled phase III randomized controlled trial (RCT) of proton therapy versus photon therapy of the prostate including the regional elective LN for localized/locally advanced prostate cancer patients combined with androgen deprivation therapy (ADT) aimed at 3 years. The investigators aim at reducing gastro-intestinal toxicity grad 2 more than 5 points, which is considered clinical significant, measured by mean Expanded Prostate Cancer Index Composite-26 (EPIC-26) bowel scores at 24 months and improve HRQOL. Secondary endpoints include morbidity, quality of life and survival data up to 10 years after treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 1, 2037
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically verified localized/locally advanced prostate cancer T1-3bN0M0 (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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Radiotherapy Side Effect

Intervention

Radiation:
• Proton therapy
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.
• Photon therapy
Patients in the photon arm will receive standard treatment with photon therapy.

Locations

Country	Name	City	State
Denmark	Dept. of Oncology, Aalborg University Hospital	Aalborg	Region North
Denmark	Department of Oncology, Aarhus University Hospital	Aarhus	Central Region
Denmark	Dept. of Oncology, Rigshospitalet, Denmark	Copenhagen	Region Hovedstaden
Denmark	Department of Oncology, Copenhagen University Hospital Herlev	Herlev	Region Hovedstaden
Denmark	Dept. of Oncology, Zealand University Hospital, Denmark	Næstved	Region Zealand
Denmark	Department of Oncology, Odense University Hospital	Odense	Region South
Denmark	Department of Oncology, Vejle Hospital, Denmark	Vejle	Region South

Sponsors (8)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg University Hospital, Aarhus University Hospital, Herlev and Gentofte Hospital, Naestved Hospital, Odense University Hospital, Rigshospitalet, Denmark, Sygehus Lillebaelt

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Physician Assessed Toxicity Number of Participants With Treatment-Related Adverse events as assessed by CTCAE v5.0	5 years
Secondary	Late GU and sexual toxicity at year 2, 5 and 10 compared to baseline (EPIC-26)	Patient Reported Outcome using on-line questionnaire to assess this outcome measure	10 years
Secondary	Late GI toxicity at year 5 compared to baseline (EPIC-26)	Patient Reported Outcome using on-line questionnaire to assess this outcome measure.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	5 years
Secondary	Acute GI at start, at the end of therapy and week 12 compared to baseline (EPIC-26)	EPIC-26	12 weeks
Secondary	Acute GI at start, at the end of therapy and week 12 compared to baseline (CTC_AEv.5.0)	Physician Assessed Toxicity	12 weeks
Secondary	Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (EPIC-26)	EPIC-26	12 weeks
Secondary	Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (CTC_AE v.5.0)	Physician Assessed Toxicity	12 weeks
Secondary	General health related quality of life (QoL) at year 2, 5 and 10 compared to baseline (EORTC QLQ-C30)	Patient Reported Outcome General health related quality of life (QoL) at year 2, 5 and 10 (EORTC QLQ-C30)	10 years
Secondary	Biochemical progression free survival (BCR), (Phoenix criteria)	blood test	10 years
Secondary	Non-biochemical progression free survival (by imaging)	Radiology assesments	10 years
Secondary	Overall survival (OS)	Follow up	10 years