Prostate Radiotherapy Comparing Moderate and Extreme Hypo-fractionation (PRIME Trial)

NCT03561961 · tracked via the Priya Life Science India tracker

Sponsor

Tata Memorial Centre

Phase

Not applicable

Started

2018-05-24

Last updated

2025-02-13

Condition(s) studied

Prostate Adenocarcinoma

Investigational drug(s) / intervention(s)

Moderate Hypo-fractionationExtreme Hypo-fractionation

Moderate Hypo-fractionation: 66-68Gy in 25#

Extreme Hypo-fractionation: 35-36.25 Gy in 5#

Study summary

Aim: The aim of the study is to compare the efficacy with SBRT and moderate hypo-fractionation in high risk and node positive prostate cancer

PRIMARY STUDY OBJECTIVES: To assess whether extreme hypo-fractionation with SBRT in high risk prostate cancer is non inferior to moderately hypo-fractionated standard radiotherapy

STUDY DESIGN: Two arm, Prospective Randomized Trial with a non-inferiority design

TREATMENT REGIMEN: Arm 1-\[standard arm\] Moderate hypo-fractionated RT, total dose of 66-68 Gray(Gy) in 25# to the primary over 5 weeks, with treatment being delivered daily. All patients irrespective of nodal status will receive a dose of 50 Gy in 25# to the pelvic nodes.Boost to gross nodal disease will be considered based on the response to hormonal therapy to a dose of 60-66 Gy/25# as a simultaneous integrated boost (SIB). An option of equivalent biological dose using 60-62.5 Gy in 20# may be allowed for multi-centric accrual in the future.

Arm 2 -\[Experimental Arm\] Extreme hypo-fractionation with SBRT,course of 5 fractions of radiation; each of size 7-7.25 Gy. The total dose will be 35-36.5 Gy. All patients irrespective of nodal status will receive a dose of 25 Gy in 5 # to the pelvic nodes. The 5 treatments will be scheduled to be delivered alternate day over approximately 7-10 days. An option of equivalent biological dose using 35-36.5 Gy in 5 weekly fractions may be allowed for multicentric accrual in the future.

RECRUITMENT TARGET: 464 total (232 patients experimental arm and 232 patients standard arm) recruitment over 6 years, with a non-fixed follow up period and a uniform accrual rate.

PRIMARY ENDPOINT To assess the 5 year Biochemical Failure free Survival (BFFS) between the two arms.

Follow-up At 3-6 weeks from end of radiotherapy, followed by 3-6 monthly for the first two years and 6 monthly thereafter.

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age: above 18 years. 2. Participants must be histologically proven, adenocarcinoma prostate 3. Localised to the prostate or pelvic lymph nodes 4. High risk prostate cancer as defined by National Comprehensive Cancer Network (NCCN):Gleason score of 8-10, clinical stage T3a or higher, or PSA \> 20 ng/mL. 5. Ability to receive long term hormone therapy/ orchidectomy 6. Karnofsky Performance Score (KPS) \>70 (see appendix 7. No prior history of therapeutic irradiation to pelvis 8. Patient willing and reliable for follow-up and QOL. 9. Signed study specific consent form Exclusion Criteria: 1. Evidence of distant metastasis at any time since presentation 2. Life expectancy \<2 year 3. Previous RT to prostate or prostatectomy. 4. A previous trans-urethral resection of the prostate (TURP) 5. Severe urinary symptoms or with severe International Prostate Symptom Score (IPSS) score despite being on hormonal therapy for 6 months which in the opinion of the physician precludes RT 6. Patients with known obstructive symptoms with stricture. 7. Any contraindication to radiotherapy like inflammatory bowel disease. 8. Uncontrolled comorbidities including, but not limited to diabetes or hypertension 9. Unable to follow up or poor logistic or social support

Primary outcome measure(s)

Biochemical Failure free Survival (BFFS) — 5 years
Freedom from biochemical failure will be defined as duration from date of nadir Prostate Specific Antigen (PSA) to PSA\>2ng/ml over the nadir PSA

Trial sites (1)

Facility	City	Region	Status
Dr Vedang Murthy	Navi Mumbai	Maharashtra

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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