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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Odense University Hospital | OTHER |
| Aarhus University Hospital | OTHER |
| Aalborg University Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Late GU and sexual toxicity at year 2, 5 and 10 compared to baseline (EPIC-26) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stine Elleberg Petersen, MD, Ph.D | Contact | +4529474408 | stinpete@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Stine Elleberg Petersen, MD, Ph.D | Danish Centre for Particle Therapy, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Oncology, Rigshospitalet, Denmark | Not yet recruiting | Copenhagen | Capital Region | Denmark |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| OTHER |
| Sygehus Lillebaelt | OTHER |
| Herlev and Gentofte Hospital | OTHER |
| Naestved Hospital | OTHER |
A randomized phase 3 study, randomizing 1:1 between photon vs. proton therapy for prostate cancer patients with high risk disease
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| Photon therapy | Radiation | Patients in the photon arm will receive standard treatment with photon therapy. |
|
Patient Reported Outcome using on-line questionnaire to assess this outcome measure |
| 10 years |
| 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 |
| Acute GI at start, at the end of therapy and week 12 compared to baseline (EPIC-26) | EPIC-26 | 12 weeks |
| Acute GI at start, at the end of therapy and week 12 compared to baseline (CTC_AEv.5.0) | Physician Assessed Toxicity | 12 weeks |
| Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (EPIC-26) | EPIC-26 | 12 weeks |
| 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 |
| 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 |
| Biochemical progression free survival (BCR), (Phoenix criteria) | blood test | 10 years |
| Non-biochemical progression free survival (by imaging) | Radiology assesments | 10 years |
| Overall survival (OS) | Follow up | 10 years |
| Department of Oncology, Copenhagen University Hospital Herlev | Recruiting | Herlev | Capital Region | DK-2730 Herlev | Denmark |
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| Department of Oncology, Aarhus University Hospital | Recruiting | Aarhus | Central Region | 8200 | Denmark |
|
| Dept. of Oncology, Aalborg University Hospital | Recruiting | Aalborg | Region North | Denmark |
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| Dept. of Oncology, Zealand University Hospital, Denmark | Recruiting | Næstved | Region Sjælland | Denmark |
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| Department of Oncology, Odense University Hospital | Not yet recruiting | Odense | Region South | 5000 | Denmark |
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| Department of Oncology, Vejle Hospital, Denmark | Recruiting | Vejle | Region South | Denmark |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014947 | Wounds and Injuries |