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Protons vs. Photons for High-risk Prostate Cancer

Primary Purpose

Prostate Cancer, Radiotherapy Side Effect

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Proton therapy
Photon therapy
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Proton Therapy, High Risk, Intensity Modulated Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Oncology, Aarhus University HospitalRecruiting
  • Dept. of Oncology, Rigshospitalet, Denmark
  • Department of Oncology, Copenhagen University Hospital Herlev
  • Dept. of Oncology, Aalborg University Hospital
  • Department of Oncology, Odense University Hospital
  • Department of Oncology, Vejle Hospital, DenmarkRecruiting
  • Dept. of Oncology, Zealand University Hospital, Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Proton therapy

Photon Therapy

Arm Description

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: 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
Acute GI at start, at the end of therapy and week 12 compared to baseline (EPIC-26)
EPIC-26
Acute GI at start, at the end of therapy and week 12 compared to baseline (CTC_AEv.5.0)
Physician Assessed Toxicity
Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (EPIC-26)
EPIC-26
Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (CTC_AE v.5.0)
Physician Assessed Toxicity
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)
Biochemical progression free survival (BCR), (Phoenix criteria)
blood test
Non-biochemical progression free survival (by imaging)
Radiology assesments
Overall survival (OS)
Follow up

Full Information

First Posted
March 16, 2022
Last Updated
April 21, 2022
Sponsor
University of Aarhus
Collaborators
Rigshospitalet, Denmark, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, Sygehus Lillebaelt, Herlev and Gentofte Hospital, Naestved Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05350475
Brief Title
Protons vs. Photons for High-risk Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 1, 2027 (Anticipated)
Study Completion Date
March 1, 2037 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Rigshospitalet, Denmark, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, Sygehus Lillebaelt, Herlev and Gentofte Hospital, Naestved Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Radiotherapy Side Effect
Keywords
Proton Therapy, High Risk, Intensity Modulated Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized phase 3 study, randomizing 1:1 between photon vs. proton therapy for prostate cancer patients with high risk disease
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proton therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Photon Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Proton therapy
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Photon therapy
Intervention Description
Patients in the photon arm will receive standard treatment with photon therapy.
Primary Outcome Measure Information:
Title
Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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)
Description
Physician Assessed Toxicity Number of Participants With Treatment-Related Adverse events as assessed by CTCAE v5.0
Time Frame
5 years
Title
Late GU and sexual toxicity at year 2, 5 and 10 compared to baseline (EPIC-26)
Description
Patient Reported Outcome using on-line questionnaire to assess this outcome measure
Time Frame
10 years
Title
Late GI toxicity at year 5 compared to baseline (EPIC-26)
Description
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
Time Frame
5 years
Title
Acute GI at start, at the end of therapy and week 12 compared to baseline (EPIC-26)
Description
EPIC-26
Time Frame
12 weeks
Title
Acute GI at start, at the end of therapy and week 12 compared to baseline (CTC_AEv.5.0)
Description
Physician Assessed Toxicity
Time Frame
12 weeks
Title
Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (EPIC-26)
Description
EPIC-26
Time Frame
12 weeks
Title
Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (CTC_AE v.5.0)
Description
Physician Assessed Toxicity
Time Frame
12 weeks
Title
General health related quality of life (QoL) at year 2, 5 and 10 compared to baseline (EORTC QLQ-C30)
Description
Patient Reported Outcome General health related quality of life (QoL) at year 2, 5 and 10 (EORTC QLQ-C30)
Time Frame
10 years
Title
Biochemical progression free survival (BCR), (Phoenix criteria)
Description
blood test
Time Frame
10 years
Title
Non-biochemical progression free survival (by imaging)
Description
Radiology assesments
Time Frame
10 years
Title
Overall survival (OS)
Description
Follow up
Time Frame
10 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Bentzen
Phone
+45 78 45 64 00
Email
lise.b@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Stine Petersen, MD
Phone
+45 29474408
Email
stinpete@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lise Bentzen, MD.Ph.d
Organizational Affiliation
Department of Oncology, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Aarhus University Hospital
City
Aarhus
State/Province
Central Region
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Bentzen, MD. Ph.d.
Phone
+45 23308530
Email
lise.b@auh.rm.dk
Facility Name
Dept. of Oncology, Rigshospitalet, Denmark
City
Copenhagen
State/Province
Region Hovedstaden
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Petersen, MD. Ph.d.
Phone
+45 51260739
Email
peter.meidahl.petersen@rh.regionh.dk
Facility Name
Department of Oncology, Copenhagen University Hospital Herlev
City
Herlev
State/Province
Region Hovedstaden
ZIP/Postal Code
DK-2730 Herlev
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henriette LIndberg, MD.Ph.d.
Phone
+45 38689597
Email
henriette.lindberg@regionh.dk
Facility Name
Dept. of Oncology, Aalborg University Hospital
City
Aalborg
State/Province
Region North
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Department of Oncology, Odense University Hospital
City
Odense
State/Province
Region South
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steinbjørn Hansen, MD.Ph.d
Phone
+45 6541 3988
Email
steinbjoern.hansen@rsyd.dk
Facility Name
Department of Oncology, Vejle Hospital, Denmark
City
Vejle
State/Province
Region South
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Madsen, MD Ph.d.
Email
Christine.Vestergaard.Madsen@rsyd.dk
Facility Name
Dept. of Oncology, Zealand University Hospital, Denmark
City
Næstved
State/Province
Region Zealand
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Redas Trapiakas, MD. Ph.d.
Phone
+45 56513231
Email
rtr@regionsjaelland.dk

12. IPD Sharing Statement

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Protons vs. Photons for High-risk Prostate Cancer

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