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Closed (no longer recruiting)Last updated: 12 February 2024

NINJA: This trial is comparing the effectiveness of two schedules of radiotherapy for the treatment of patients with prostate cancerThe NINJA Clinical Trial: Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation

Clinical summary

Summary

Patients eligible to participate in this study will receive radiation therapy, which will be delivered by one of two schedules. The first schedule will involve 40 Grays (Gy) of radiation delivered in five fractions 1-3 times per week. The second schedule will involve 20Gy in 2 fractions delivered once per week, followed by a two week break and 36Gy in 12 fractions, delivered 4-5 times per week. All patients will receive injections of androgen deprivation therapy for 6 months, commencing 3-4 months prior to radiation.

Conditions

This trial is treating patients with prostate cancer.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

Not applicable

Trial Acronym

NINJA

More information

Trial Identifiers

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Trial sponsor

Mundipharma Research Limited,Australian and New Zealand Urogenital and Prostate cancer trials group (ANZUP),Trans Tasman Radiation Oncology Group (TROG)

Scientific Title

The NINJA Clinical Trial: Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation

Eligibility

Inclusion

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

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

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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