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NCT Number: NCT04612907

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent
  • Histological confirmed prostate cancer
  • 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
  • baseline E-PROM

Exclusion criteria

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

Treatment and study plan

Moderate hypo-fractionation

Radiation

Patients will receive four weeks of radiotherapy

Ultra-hypo-fractionation

Radiation

Patients will receive two and a half weeks of radiotherapy

Primary outcomes

  1. Toxicity as scored by PROM (Patient Reported Outcome Measures) at 8 weeks

    Time frame: 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

  2. Toxicity as scored by PROM at 8 weeks

    Time frame: 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

Secondary outcomes

  1. Failure free survival

    Time frame: 12 months, 36 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Thellenberg Karlsson, MD, PhD

CONTACT

[email protected]

+46 90 785 3296

Karin Söderkvist, MD, PhD

CONTACT

[email protected]

+4690 785 00 00

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

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

Acronym: Hypo-M1

Important dates

Study start
2022
Primary completion
2026
Study completion
2032
First posted
Nov 3, 2020
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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