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

Prostate Cancer Clinical Trial

— Hypo-M1  

Official title:

A Randomized Phase III, Multicenter Study to Evaluate Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04612907
• Other study ID #: Hypo-M1 1.0
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: September 30, 2032

Study information

• Verified date: February 2024
• Source: Umeå University
• Contact: Camilla Thellenberg Karlsson, MD, PhD
• Phone: +46 90 785 3296
• Email: camilla.thellenberg[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: September 30, 2032
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Metastatic Cancer
• Prostate Cancer
• Prostatic Neoplasms
• Radiotherapy Side Effect

Intervention

Radiation:
• Moderate hypo-fractionation
Patients will receive four weeks of radiotherapy
• Ultra-hypo-fractionation
Patients will receive two and a half weeks of radiotherapy

Locations

Country	Name	City	State
Sweden	Cancercenter University hospital of Umeå	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity as scored by PROM (Patient Reported Outcome Measures) at 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	8 weeks
Primary	Toxicity as scored by PROM at 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	8 weeks
Secondary	Failure free survival	To evaluate the proportion of patients that are failure free at 12 and 36 months, failure free survival (FFS)	12 months, 36 months