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

NCT03561961 | Active Not Recruiting DMC

• 1 other identifier: PRIME
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Biochemical Failure free Survival (BFFS)

  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

  5 years

Secondary Outcomes (6)

• Acute toxicity with both treatments.

  2 years

• Late toxicity with both treatments.

  2 years

• Prostate cancer specific survival

  5 years

• Overall Survival

  5 years

• out of pocket expenditure

  Baseline, 2 and 5 years

Study Arms (2)

Moderate Hypo-fractionation

ACTIVE COMPARATOR

In arm 1 of the study, patients who are randomized to receive moderately hypo-fractionated RT will receive a total dose of 66-68 Gy in 25# to the primary over 5 weeks, with treatment being delivered daily. All patients will receive a dose of 50 Gy in 25# to the pelvis. 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).

Radiation: Moderate Hypo-fractionation

Extreme Hypo-fractionation

EXPERIMENTAL

In Arm 2 of the study, patients who are scheduled to receive SBRT will receive a course of 5 fractions of radiation; each fraction size will be 7.00-7.25 Gy. The total dose will be 35-36.5 Gy. All patients will receive a dose of 25 Gy in 5 # to the pelvis. Boost to gross nodal disease will be considered based on the response to hormonal therapy to a dose of 30-35 Gy/5# as a simultaneous integrated boost(SIB).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.

Radiation: Extreme Hypo-fractionation

Interventions

Moderate Hypo-fractionation RADIATION

66-68Gy in 25#

Moderate Hypo-fractionation

Extreme Hypo-fractionation RADIATION

35-36.25 Gy in 5#

Also known as: SBRT

Extreme Hypo-fractionation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: above 18 years.
• Participants must be histologically proven, adenocarcinoma prostate
• Localised to the prostate or pelvic lymph nodes
• 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.
• Ability to receive long term hormone therapy/ orchidectomy
• Karnofsky Performance Score (KPS) \>70 (see appendix
• No prior history of therapeutic irradiation to pelvis
• Patient willing and reliable for follow-up and QOL.
• Signed study specific consent form

You may not qualify if:

• Evidence of distant metastasis at any time since presentation
• Life expectancy \<2 year
• Previous RT to prostate or prostatectomy.
• A previous trans-urethral resection of the prostate (TURP)
• 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
• Patients with known obstructive symptoms with stricture.
• Any contraindication to radiotherapy like inflammatory bowel disease.
• Uncontrolled comorbidities including, but not limited to diabetes or hypertension
• Unable to follow up or poor logistic or social support

Sponsors & Collaborators

• Tata Memorial Centre: lead
• Tata Medical Center: collaborator

Study Sites (1)

Dr Vedang Murthy

Navi Mumbai, Maharashtra, 410210, India

Location

Related Publications (1)

• Murthy V, Mallick I, Gavarraju A, Sinha S, Krishnatry R, Telkhade T, Moses A, Kannan S, Prakash G, Pal M, Menon S, Popat P, Rangarajan V, Agarwal A, Kulkarni S, Bakshi G. Study protocol of a randomised controlled trial of prostate radiotherapy in high-risk and node-positive disease comparing moderate and extreme hypofractionation (PRIME TRIAL). BMJ Open. 2020 Feb 28;10(2):e034623. doi: 10.1136/bmjopen-2019-034623.

  PMID: 32114475 BACKGROUND

Related Links

• Acute toxicity

Study Officials

• Vedang Murthy

  Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Radiation Oncology

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 19, 2018
• Study Start: May 24, 2018
• Primary Completion: September 27, 2024
• Study Completion (Estimated): March 1, 2035
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

IN (1)