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

Primary Purpose

Prostate Cancer, Radiotherapy Side Effect, Metastatic Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Moderate hypo-fractionation

Ultra-hypo-fractionation

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Metastatic prostate cancer radiotherapy primary tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

Cancercenter University hospital of UmeåRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Moderate hypo-fractionation

Ultra hypo-fractionation

Arm Description

Radiotherapy to the prostate delivered in 3Gy fractions x 19

Radiotherapy to the prostate delivered in 6.1Gy fractions x 6

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Failure free survival

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

Full Information

NCT ID

NCT04612907

First Posted

October 20, 2020

Last Updated

November 1, 2022

Sponsor

Umeå University

1. Study Identification

Unique Protocol Identification Number

NCT04612907

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 31, 2022 (Anticipated)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

September 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Umeå University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Radiotherapy Side Effect, Metastatic Cancer

Keywords

Metastatic prostate cancer radiotherapy primary tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients will be randomized to one of two treatment fractionations of radiotherapy

Masking

None (Open Label)

Allocation

Randomized

Enrollment

420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Moderate hypo-fractionation

Arm Type

Active Comparator

Arm Description

Radiotherapy to the prostate delivered in 3Gy fractions x 19

Arm Title

Ultra hypo-fractionation

Arm Type

Experimental

Arm Description

Radiotherapy to the prostate delivered in 6.1Gy fractions x 6

Intervention Type

Radiation

Intervention Name(s)

Moderate hypo-fractionation

Intervention Description

Patients will receive four weeks of radiotherapy

Intervention Type

Radiation

Intervention Name(s)

Ultra-hypo-fractionation

Intervention Description

Patients will receive two and a half weeks of radiotherapy

Primary Outcome Measure Information:

Title

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

Description

Time Frame

8 weeks

Title

Toxicity as scored by PROM at 8 weeks

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Failure free survival

Description

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

Time Frame

12 months, 36 months

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Prostate cancer is a male disease

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Camilla Thellenberg Karlsson, MD, PhD

Phone

+46 90 785 3296

camilla.thellenberg@umu.se

First Name & Middle Initial & Last Name or Official Title & Degree

Karin Söderkvist, MD, PhD

Phone

+4690 785 00 00

karin.soderkvist@umu.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Camilla of T Karlsson

Organizational Affiliation

Cancercentrum Umeå University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancercenter University hospital of Umeå

City

Umeå

ZIP/Postal Code

90596

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Camilla Thellenberg Karlsson, MD, PhD

Phone

+46907853296

camilla.thellenberg@umu.se

First Name & Middle Initial & Last Name & Degree

Karin Söderkvist, MD, PhD

Phone

+46907850000

karin.soderkvist@umu.se

12. IPD Sharing Statement

Learn more about this trial

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

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