High dose Radiation therapy to eradicate early metastatic prostate cancer as an alternative to hormone or chemotherapy: a prospective phase II study

• Register: ANZCTR
• Last refreshed on: 22 January 2024
• Main ID: ACTRN12618000566235
• Date of registration: 13/04/2018
• Prospective Registration: No
• Primary sponsor: Integrated Clinical Oncology Network Pty Ltd (ICON)
• Public title: High dose Radiation therapy to eradicate early metastatic prostate cancer as an alternative to hormone or chemotherapy: a prospective phase II study
• Scientific title: Ablative Stereotactic Radiotherapy as an alternative to systemic treatment in men with oligometastatic prostate cancer and controlled primary disease. A prospective Phase II study measuring toxicity, disease control and freedom from escalation in systemic therapy
• Date of first enrolment: 14/04/2014
• Target sample size: 200
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12618000566235.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Type of endpoint: Efficacy;
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Dr Patrick Bowden

• Name: Dr Lloyd Smyth

Key inclusion & exclusion criteria

Inclusion criteria: - Histologically confirmed diagnosis of prostate cancer.
- Biochemical relapses of prostate cancer following radical local treatment.
- Males aged 18 years to 80 years inclusive.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- N1 and M1 a/b disease on imaging, with a combined maximum of five synchronous lesions
- Exclusion of local relapse.
- Metastases suitable for ablative radiotherapy
Exclusion criteria: - No prior palliative radiotherapy (definitive radiotherapy as part of initial management is allowed).
- Active local disease on clinical examination.

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Males

Health Condition(s) or Problem(s) studied

Prostate Cancer;
Prostate Cancer

Cancer - Prostate

Intervention(s)

Enrolled patients will receive a course of stereotactic radiotherapy delivered five days a week over two weeks. The total dose of radiotherapy will be 50Gy in 10 fractions with 1 fraction delivered daily for 10 consecutive days (excluding weekends and public holidays). If there is overlap with previously delivered radiotherapy fields, an alternate fractionation schedule is acceptable given that an equivalent total dose in 2Gy fractions (EQD2) of at least 60Gy can be maintained.
Radiotherapy will be delivered by a radiation therapy team consisting of suitably qualified personnel and each treatment session will take approximately 10 minutes. The medical physics team is involved in planning prior to treatment to ensure accuracy of treatment delivery. A treatment delivery report will be produced and if any action level is exceeded, including significant internal organ variations or changes in the target volume that were not accommodated by prescribed treatment margins, the treatment plan will be redirected for immediate review and action by the appropriate staff.

Primary Outcome(s)

The proportion of patients not requiring treatment escalation at 5 and 10 years. These data will be collected through scheduled patient assessments and medical records. [ 6 weeks post-radiotherapy, three monthly until two years post-radiotherapy, six monthly until five years and then annually up to 10 years post-radiotherapy. The primary outcome will be assessed as time to event over the give year period.]

Secondary Outcome(s)

Rate of SBRT related grade 3 toxicity as measured by CTCAE version 4.0 criteria. [ 6 weeks post-radiotherapy, three monthly until two years post-radiotherapy, six monthly until five years post-radiotherapy and then annually to 10 years. ]

Change in % PSA post-treatment (pathological assessment at each follow-up time point)[ 6 weeks post-radiotherapy, three monthly until two years post-radiotherapy, six monthly until five years post-radiotherapy and then annually to 10 years. ]

Length of treatment escalation free survival (oncologist reported or obtained through medical records)[ 6 weeks post-radiotherapy, three monthly until two years post-radiotherapy, six monthly until five years post-radiotherapy and then annually to 10 years. ]

The proportion of patients with no systemic treatment progression and no evaluable cancer at 10 years (i.e. PSA <0.03 ng/mL). This is assessed through the medical record.[ 6 weeks post-radiotherapy, three monthly until two years post-radiotherapy, six monthly until five years post-radiotherapy and then annually to 10 years. ]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Epworth Medical Foundation

Ethics review

Status: Approved
Approval date: 20/02/2014
Contact:

Epworth HealthCare HREC

Status: Approved
Approval date: 08/03/2019
Contact:

Monash Health HREC

Results

• Date Posted: 18/03/2019