The NINJA Clinical Trial: Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation for patients with intermediate or low-high risk prostate cancer.

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12618001806257
• Lead Sponsor: Trans Tasman Radiation Oncology Group (TROG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-06
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 472

Inclusion Criteria

Unfavourable intermediate or low-high risk prostate cancer
- ISUP 2 AND EITHER PSA 10-20, OR T2b/c AND greater than or equal to 50% Biopsy Cores Positive
- ISUP 3 AND PSA less than or equal to 20 OR
- ISUP 4-5 (NOT predominant pattern 5 disease) OR T3a AND PSA less than and equal to 20
Staging investigations showing N0M0 disease performed within 60 days prior to commencing ADT or antiandrogen:
- For high risk patients, PSMA PET staging within 60 days prior to study entry showing N0M0 disease.
- For unfavourable intermediate risk patients, either PSMA PET alone OR whole body bone scan AND EITHER CT abdomen/pelvis OR MRI prostate/pelvis.
Histologically confirmed prostate cancer
ECOG performance status of 0-1.
Life expectancy greater than 5 years.

Exclusion Criteria

Higher risk prostate cancer:
- T3b or T4 based on all clinical information available including examination and investigations
- PSA greater than 20
- Dominant pattern 5 histology (ie Gleason score 5+4 or 5+5)
Previous pelvic radiotherapy
Prior diagnosis of cancer that was:
- more than 5 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10%
- within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
Patients with clinical evidence of metastatic disease.
Presence of total hip joint replacement
Clinical Target volume greater than 100cc
Severe obstructive lower urinary tract symptoms (IPSS greater than an equal to 20)
Any contraindications to performance of a planning MRI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Biochemical Clinical Control (BCC). Prostate cancer biochemical control measured by Phoenix definition of nadir + 2ng/mL (blood PSA measurement) and/or detection of metastases (imaging or other) or initiation of salvage intervention (further treatment) by the 5 year time point[ Assessed 6 wks post SBRT and then 6 monthly up to 5 years]

Secondary Outcome Measures

Name	Time	Method
Rate of replanning following Knowledge Based Planning (KBP) feedback to trial centres. Rate of replanning prior to radiotherapy treatment performed by trial centres following KBP comparison against initial plan. In KBP, a model is developed using a range of patient anatomies and target volumes. This can then be rapidly applied to a new case to either generate a plan de novo, or compare with a conventional plan.[ Within 12 months after first 150 participants accrued.];Rate of trial centre conversion to prostate Magnetic Resonance Imaging (MRI) only planning. The rate of full conversion to MRI based prostate radiotherapy planning (i.e. CT scan no longer required to complete radiotherapy planning). Modern RT planning uses electron density from a CT dataset to calculate dose. Many centres now acquire both a CT and a MRI.[ Within 12 months after first 150 participants accrued]