Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer (Hypo-M1)

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

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

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Metastatic Cancer; Radiotherapy Side Effect
• Intervention / Treatment: Radiation: Moderate hypo-fractionation; Radiation: Ultra-hypo-fractionation

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 Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camilla Thellenberg Karlsson, MD, PhD; Phone Number: +46 90 785 3296; Email: camilla.thellenberg@umu.se
• Study Contact Backup: Name: Karin Söderkvist, MD, PhD; Phone Number: +4690 785 00 00; Email: karin.soderkvist@umu.se

Study Locations

• Sweden
  • Umeå, Sweden, 90596
    • Recruiting
    • Cancercenter University hospital of Umeå
    • Contact: Camilla Thellenberg Karlsson, MD, PhD; Phone Number: +46907853296; Email: camilla.thellenberg@umu.se
    • Contact: Karin Söderkvist, MD, PhD; Phone Number: +46907850000; Email: karin.soderkvist@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Moderate hypo-fractionation; Radiotherapy to the prostate delivered in 3Gy fractions x 19	Radiation: Moderate hypo-fractionation; Patients will receive four weeks of radiotherapy
Experimental: Ultra hypo-fractionation; Radiotherapy to the prostate delivered in 6.1Gy fractions x 6	Radiation: Ultra-hypo-fractionation; Patients will receive two and a half weeks of radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Camilla of T Karlsson, Cancercentrum Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2032

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Metastatic prostate cancer radiotherapy primary tumor
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Hypo-M1 1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No