Focal Radiotherapy for Previously Treated Prostate Cancer Patients

Locally Recurrent Prostate Cancer Clinical Trial

Official title:

Phase I Feasibility Trial of Stereotactic Re-irradiation of Prostate Cancer Recurrence Within the Definitively Irradiated Prostate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03073278
• Other study ID #: Focal SBRT prostate
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: March 31, 2027

Study information

• Verified date: November 2023
• Source: Royal North Shore Hospital
• Contact: Carolyn Kwong
• Phone: +61 2 9463 1339
• Email: carolyn.kwong[@]health.nsw.gov.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Locally Recurrent Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Stereotactic Body Radiotherapy
Each group will have different dose of stereotactic body radiotherapy (SBRT). Depending on which group patients are in.

Locations

Country	Name	City	State
Australia	Royal North Shore Hospital	St Leonards	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Royal North Shore Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of SBRT dose escalation. This will be assessed by the number of participants with grade 3 acute toxicity according to CTCAE version 4.3	acute toxicity will be assessed weekly during treatment period to check whether dose escalation can be achieved	at weekly review through completion of each radiothrapy dose level, approximately one year
Primary	safety of SBRT dose escalation. This will be assessed by the number of participants with grade 3 acute toxicity according to CTCAE version 4.3	outcome will be assessed by reviewing toxicity weekly during the treatment period and at the end of each dose escalation	at weekly review through completion of each radiothrapy dose level, approximately one year
Primary	Toxicity. This will be assessed by the number of participants with grade 3 acute toxicity according to CTCAE version 4.3 and RTOG toxicity score.	outcome will be assessed by reviewing toxicity weekly and at the end of each dose escalation	at weekly review through completion of each radiothrapy dose level, approximately one year
Secondary	Tolerability of conservation dose escalation in this cohort of patients	outcome will be assessed by reviewing toxicity weekly or secondly weekly and at the end of each dose escalation	After each group of patients have completed radiotherapy and at 12 and 24 months follow-up. Patients will have routine follow-up 6 monthly for 1 year and then yearly for 10 years post treatment. But study outcomes will only be collected for 2 years.