Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer

Not Applicable

Recruiting

• Conditions: Radiotherapy Side Effect; Prostate Cancer; Metastatic Cancer
• Interventions: Radiation: Moderate hypo-fractionation; Radiation: Ultra-hypo-fractionation

• Registration Number: NCT04612907
• Lead Sponsor: Umeå University

Brief Summary

de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested.

Detailed Description

Patients with de Novo metastatic prostate cancer with limited disease spread has been shown to gain benefit from local radiotherapy to the prostate. The internationally accepted fractionation schedule is 3 Gy (Gray) x 19-20 over a course of 4 weeks.

There is continous evidence for even more hypo-fractionated radiotherapy with higher fractionation doses. We will test if the schedule of 6.1Gy x 6 compares to standard of 3 Gy x 19 with regard to patient reported side-effects.

Study Timeline

• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-03
• Study Start: 2022-10-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2026-06-30
• Study Completion: 2032-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 420

Inclusion Criteria

1. Signed Informed Consent
2. Histological confirmed prostate cancer
3. Indication for early palliative radiation therapy of low burden metastatic prostate cancer. Low burden as defined by modified CHAARTED trial criteria to maximum 4 skeletal mets at any site and/or any number of lymph nodes
4. baseline E-PROM

Exclusion Criteria

1. High burden metastatic prostate cancer including all with visceral mets.
2. Unable to comply with study procedures.
3. Other diseases or medication that will put the patient at risk for more toxicity from radiotherapy
4. Radiation treatment start later than nine months after the prostate cancer diagnosis.
5. Severe micturition problems, IPSS > 20 ( International Prostate Symptom Score)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate hypo-fractionation	Moderate hypo-fractionation	Radiotherapy to the prostate delivered in 3Gy fractions x 19
Ultra hypo-fractionation	Ultra-hypo-fractionation	Radiotherapy to the prostate delivered in 6.1Gy fractions x 6

Primary Outcome Measures

Name	Time	Method
Toxicity as scored by PROM at 8 weeks	8 weeks	Acute toxicity score by PROM at eight weeks post radiotherapy. The mean PCSS bother score for bowel will be measured. The primary outcome measurement will be the difference between mean values in the respective treatment arms measured at 8 weeks after end of radiotherapy
Toxicity as scored by PROM (Patient Reported Outcome Measures) at 8 weeks	8 weeks	Acute toxicity score by PROM at eight weeks post radiotherapy. The mean PCSS (Prostate Cancer Symptom Scale) bother score for urinary tract will be measured. The primary outcome measurement will be the difference between mean values in the respective treatment arms measured at 8 weeks after end of radiotherapy

Secondary Outcome Measures

Name	Time	Method
Failure free survival	12 months, 36 months	To evaluate the proportion of patients that are failure free at 12 and 36 months, failure free survival (FFS)

Trial Locations

Locations (1)

Cancercenter University hospital of Umeå; 🇸🇪 Umeå, Sweden