Focal Radiotherapy for Previously Treated Prostate Cancer Patients

NCT ID: NCT03073278

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-24
• Study Completion Date: 2027-03-31

Brief Summary

To examine the feasibility, safety and toxicity of focal stereotactic radiation treatment (SBRT) for locally recurrent prostate cancer.

Detailed Description

Participants must have biopsy proven locally recurrent prostate cancer. Biopsy will be performed by a Urologist. Participants will have PSMA-PET (prostate-specific membrane antigen and positron emission tomography) scan and MRI in Radiology and Nuclear Medicine by experienced Radiologists in the Royal North Shore Hospital. before starting stereotactic radiotherapy. Participants will require fiducial markers inserted in the prostate and may require hydrogel insertion depending on the location of the recurrence. If these are required, it will be done by experienced radiation oncologists. Fiducial markers insertion involves inserting three gold markers into the prostate. It will be used to locate the prostate accurately during radiation treatment. Hydrogel is a temporary gel being injected into the space between the prostate and rectum to reduce the dose of radiation received by the rectum to minimise side effects from the treatment, Focal Stereotactic Body treatment (SBRT) will be used in the study. There are three groups of participants. Each group will receive different level of radiation dose to test the safety of increasing radiation dose. Group 1 will receive 36 grays (radiation dose unit, Gy)) in 6 treatments. Group 2 will receive 38 grays in 6 treatments and Group 3 will receive 40 grays in 6 treatments. The incremental dose escalation will cease if any excess acute toxicity or late grade 3 toxicity. SBRT will be delivered two to three times per week, every second day. The number of treatments per week will depend on the day of the week participants start their treatment. Participants will be reviewed weekly or second weekly. Toxicity will be recorded. A Safety Committee will be formed containing multi-disciplinary team members. All serious adverse events will be reported to the Principal Investigator and Human Research Ethics Committee within 24 hours.

Conditions

Locally Recurrent Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

This group of 12 patients will be given 36Gy of Stereotactic Body Radiotherapy (SBRT) divided into six separate doses. This will be delivered two to three time per week.

Group Type: OTHER

Stereotactic Body Radiotherapy

Intervention Type: RADIATION

Each group will have different dose of stereotactic body radiotherapy (SBRT). Depending on which group patients are in.

Group 2

This group (12 patients) will be given 38Gy of Stereotactic Body Radiotherapy (SBRT) divided into six separate doses. This will be delivered two to three time per week.

Group Type: OTHER

Stereotactic Body Radiotherapy

Intervention Type: RADIATION

Each group will have different dose of stereotactic body radiotherapy (SBRT). Depending on which group patients are in.

group 3

This group (12 patients) will be given 40Gy of Stereotactic Body Radiotherapy (SBRT) divided into six separate doses. This will be delivered two to three time per week.

Group Type: OTHER

Stereotactic Body Radiotherapy

Intervention Type: RADIATION

Each group will have different dose of stereotactic body radiotherapy (SBRT). Depending on which group patients are in.

Interventions

Stereotactic Body Radiotherapy

Each group will have different dose of stereotactic body radiotherapy (SBRT). Depending on which group patients are in.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Men > 4yrs from external beam radiotherapy (EBRT) meeting the Phoenix definition of biochemical failure or men > 5yrs from EBRT if neo-adjuvant and/or adjuvant androgen deprivation therapy (ADT) also used
• Recurrence localised to less than 1 lobe of prostate on both PMSA and multi-parametric MRI (less than equal to cT2a)
• Recurrence must be biopsy proven, with positive biopsies limited to the PET and MRI suspicious region.
• Life expectancy at least 10yrs from time of SBRT
• PSA < 10

Exclusion Criteria

• Recurrence in immediate proximity to rectum (unless able to have hydrogel)
• Grade 3 or more toxicity from previous EBRT
• Contra-indicated for fiducial insertion
• GS 8,9 or 10 disease previously (relative - consider if decent disease free interval)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Royal North Shore Hospital

OTHER

Sponsor Role: lead

Responsible Party

A/Prof. George Hruby

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George Hruby

Role: PRINCIPAL_INVESTIGATOR

Northern Sydney Local Health District

Locations

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Carolyn Kwong

Role: CONTACT

carolyn.kwong@health.nsw.gov.au

+61 2 9463 1339

Heidi Tsang

Role: CONTACT

heidi.tsang@health.nsw.gov.au

+61 2 9463 1340

Facility Contacts

Carol Kwong, RN

Role: primary

carolyn.kwong@health.nsw.gov.au

+6129463 1339

Clare Banks, RN

Role: backup

heidi.tsang@health.nsw.gov.au

+6129463 1340

Other Identifiers

Focal SBRT prostate

Identifier Type: -

Identifier Source: org_study_id