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

Umeå University

Status: Enrolling

Conditions: Metastatic Cancer; Radiotherapy Side Effect; Prostate Cancer

Treatments: Radiation: Ultra-hypo-fractionation; Radiation: Moderate hypo-fractionation

Study type: Interventional

Funder types: Other

Identifiers

NCT04612907

Hypo-M1 1.0

Details and patient eligibility

About

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

Full 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.

Enrollment: 420 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

420 participants in 2 patient groups

Moderate hypo-fractionation

Active Comparator group

Description:

Radiotherapy to the prostate delivered in 3Gy fractions x 19

Treatment:

Radiation: Moderate hypo-fractionation

Ultra hypo-fractionation

Experimental group

Description:

Radiotherapy to the prostate delivered in 6.1Gy fractions x 6

Treatment:

Radiation: Ultra-hypo-fractionation