Protons vs. Photons for High-risk Prostate Cancer

• Sponsor: University of Aarhus (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05350475
• Collaborator: Rigshospitalet, Denmark (Other), Odense University Hospital (Other), Aarhus University Hospital (Other), Aalborg University Hospital (Other), Sygehus Lillebaelt (Other), Herlev and Gentofte Hospital (Other), Naestved Hospital (Other)
• Enrollment: 400
• Locations: 7
• Arms: 2
• Anticipated Duration (Months): 180
• Patients Per Site: 57.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Radiotherapy Side Effect	Radiation: Proton therapy; Radiation: Photon therapy	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A randomized phase 3 study, randomizing 1:1 between photon vs. proton therapy for prostate cancer patients with high risk diseaseA randomized phase 3 study, randomizing 1:1 between photon vs. proton therapy for prostate cancer patients with high risk disease
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2027
• Anticipated Study Completion Date: Mar 1, 2037

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Proton therapy 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; 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.
Active Comparator: Photon Therapy 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; Patients in the photon arm will receive standard treatment with photon therapy.

Outcome Measures

Primary Outcome Measures

1. Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26) [2 years]

   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.

Secondary Outcome Measures

1. 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]

   Physician Assessed Toxicity Number of Participants With Treatment-Related Adverse events as assessed by CTCAE v5.0

2. Late GU and sexual toxicity at year 2, 5 and 10 compared to baseline (EPIC-26) [10 years]

   Patient Reported Outcome using on-line questionnaire to assess this outcome measure

3. Late GI toxicity at year 5 compared to baseline (EPIC-26) [5 years]

   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

4. Acute GI at start, at the end of therapy and week 12 compared to baseline (EPIC-26) [12 weeks]

   EPIC-26

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

   Physician Assessed Toxicity

6. Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (EPIC-26) [12 weeks]

   EPIC-26

7. Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (CTC_AE v.5.0) [12 weeks]

   Physician Assessed Toxicity

8. General health related quality of life (QoL) at year 2, 5 and 10 compared to baseline (EORTC QLQ-C30) [10 years]

   Patient Reported Outcome General health related quality of life (QoL) at year 2, 5 and 10 (EORTC QLQ-C30)

9. Biochemical progression free survival (BCR), (Phoenix criteria) [10 years]

   blood test

10. Non-biochemical progression free survival (by imaging) [10 years]

    Radiology assesments

11. Overall survival (OS) [10 years]

    Follow up

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Oncology, Aarhus University Hospital	Aarhus	Central Region	Denmark	8200
2	Dept. of Oncology, Rigshospitalet, Denmark	Copenhagen	Region Hovedstaden	Denmark
3	Department of Oncology, Copenhagen University Hospital Herlev	Herlev	Region Hovedstaden	Denmark	DK-2730 Herlev
4	Dept. of Oncology, Aalborg University Hospital	Aalborg	Region North	Denmark
5	Department of Oncology, Odense University Hospital	Odense	Region South	Denmark	5000
6	Department of Oncology, Vejle Hospital, Denmark	Vejle	Region South	Denmark
7	Dept. of Oncology, Zealand University Hospital, Denmark	Næstved	Region Zealand	Denmark

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Lise Bentzen, MD.Ph.d, Department of Oncology, Aarhus University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT05350475
• Other Study ID Numbers: 1-10-72-290-21
• First Posted: Apr 28, 2022
• Last Update Posted: Apr 28, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Aarhus: Proton Therapy; High Risk; Intensity Modulated Radiotherapy
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Apr 28, 2022