NCT04612907

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
78mo left

Started Oct 2022

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Oct 2022Sep 2032

First Submitted

Initial submission to the registry

October 20, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

October 31, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2032

Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3.7 years

First QC Date

October 20, 2020

Last Update Submit

February 27, 2024

Conditions

Prostate CancerRadiotherapy Side EffectMetastatic Cancer

Keywords

Metastatic prostate cancer radiotherapy primary tumor

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Failure free survival

    12 months, 36 months

Study Arms (2)

Moderate hypo-fractionation

ACTIVE COMPARATOR

Radiotherapy to the prostate delivered in 3Gy fractions x 19

Radiation: Moderate hypo-fractionation

Ultra hypo-fractionation

EXPERIMENTAL

Radiotherapy to the prostate delivered in 6.1Gy fractions x 6

Radiation: Ultra-hypo-fractionation

Interventions

Moderate hypo-fractionationRADIATION

Patients will receive four weeks of radiotherapy

Moderate hypo-fractionation
Ultra-hypo-fractionationRADIATION

Patients will receive two and a half weeks of radiotherapy

Ultra hypo-fractionation

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate cancer is a male disease
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancercenter University hospital of Umeå

Umeå, 90596, Sweden

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsRadiation InjuriesNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesWounds and InjuriesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Camilla of T Karlsson

    Cancercentrum Umeå University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Thellenberg Karlsson, MD, PhD

CONTACT

+46 90 785 3296camilla.thellenberg@umu.se

Karin Söderkvist, MD, PhD

CONTACT

+4690 785 00 00karin.soderkvist@umu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomized to one of two treatment fractionations of radiotherapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2020

First Posted

November 3, 2020

Study Start

October 31, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2032

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

SE(1)