Prostate AdenocarcinomaPRIMENCT03561961
Prostate Radiotherapy Comparing Moderate and Extreme Hypo-fractionation (PRIME Trial)
A study testing Moderate Hypo-fractionation and Extreme Hypo-fractionation in people with Prostate Adenocarcinoma, run by Tata Memorial Centre at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Moderate Hypo-fractionation and Extreme Hypo-fractionation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- 1 siteIndia
- Study dates
- 24 May 2018to Mar 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- No prior history of therapeutic irradiation to pelvis
- Patient willing and reliable for follow-up and QOL.
- Signed study specific consent form
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial of Prostate Radiotherapy In High Risk and Node Positive Disease Comparing Moderate and Extreme Hypo-fractionation (PRIME Trial)
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
Read more
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.
Read the detailed description
The standard duration of treatment with radiotherapy is 8 weeks in conventional fractionation; 5-6 weeks with moderate hypo-fractionation, while it is only 1- 2 weeks with extreme hypo-fractionation (SBRT).The health costs and out of pocket expenditure involved in the conventional hypo-fractionated radiotherapy treatment largely depends on the overall treatment duration. This involves expenditure not only for the patient but also the caretaker. Moreover most of these patients presenting to a tertiary care centre from different parts of the country, have logistic issues of accommodation, food, travel along with the treatment costs. Also for patients staying away from family, 5 weeks treatment without considerable family support has a psychological impact, especially on elderly group of patients commonly seen with prostate cancer.This further leads to a major cause of distress among these patients, especially in a resource limited setting as ours.
Extreme hypo-fractionation with a total duration of 2 weeks, would offer an opportunity to optimize the therapeutic ratio taking advantage of the potential therapeutic gain due to low alpha/beta for prostate to higher dose/fraction(compared to surrounding organs at risk). Moreover, shortened overall treatment time,would lead to less distressing and early recommencement of their daily activities for the patients,with an obvious impact in improving the quality of life and health costs.
Given the potential positive economic impact with shorter duration treatment with similar clinical outcomes and probable similar toxicity profile, SBRT (extreme hypo-fractionation) in prostate cancer is an attractive treatment option, especially in a limited-resource setting and can have a large and positive impact on the patient care.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Moderate Hypo-fractionation, Extreme Hypo-fractionation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Hypo-fractionationRadiation
66-68Gy in 25#
Extreme Hypo-fractionationRadiation
Also called SBRT
35-36.25 Gy in 5#
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Radiation: Extreme Hypo-fractionation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (6)
Acute toxicity with both treatments.
Radiation Therapy Oncology Group (RTOG) and CTCAE v 4
Measured: 2 years
Late toxicity with both treatments.
Radiation Therapy Oncology Group (RTOG) and CTCAE v 4
Measured: 2 years
Prostate cancer specific survival
calculated from the date of randomization to the date of the death due to prostate cancer
Measured: 5 years
Overall Survival
defined as the time from randomization to the time of death from any cause
Measured: 5 years
out of pocket expenditure
structured case record form
Measured: Baseline, 2 and 5 years
patient reported quality of life
EORTC Quality of Life Questionnaire Core 30 (QLQc30) and Prostate 25 (PR25)
Measured: baseline and every 6 monthly for five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start24 May 2018
- Primary completion27 Sep 2024
- Study completionMar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Tata Medical Center
- Responsible party
- Principal investigator, Dr Vedang Murthy, Tata Memorial Centre
- Investigators
- Vedang Murthy, Principal investigator, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561961
- Sponsor's protocol ID
- PRIME
- Acronym
- PRIME
- Status last verified
- Feb 2025
- First submitted
- 23 May 2018
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32114475Murthy V, Gulati S, Ghosh S, Sable S, Phurailatpam R, Patil D, Mhatre R, Chougle N, Solanki M, Singh M, Verma P, Singh P, Maitre P. Empty-RT: A Phase 2 Trial of Prostate Stereotactic Body Radiation Therapy With an Empty Bladder Approach. Int J Radiat Oncol Biol Phys. 2026 Jul 31:S0360-3016(26)04064-2. doi: 10.1016/j.ijrobp.2026.07.018. Online ahead of print.
PubMed 42537851
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Prostate Radiotherapy In High Risk and Node Positive Disease Comparing Moderate and Extreme Hypo-fractionation (PRIME Trial)
- ClinicalTrials.gov ID
- NCT03561961
- Acronym / sponsor ID
- PRIME / PRIME
- Conditions
- Prostate Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Collaborators
- Tata Medical Center
- Study start
- 24 May 2018 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- Mar 2035 (estimated)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The standard duration of treatment with radiotherapy is 8 weeks in conventional fractionation; 5-6 weeks with moderate hypo-fractionation, while it is only 1- 2 weeks with extreme hypo-fractionation (SBRT).The health costs and out of pocket expenditure involved in the conventional hypo-fractionated radiotherapy treatment largely depends on the overall treatment duration. This involves expenditure not only for the patient but also the caretaker. Moreover most of these patients presenting to a tertiary care centre from different parts of the country, have logistic issues of accommodation, food, travel along with the treatment costs. Also for patients staying away from family, 5 weeks treatment without considerable family support has a psychological impact, especially on elderly group of patients commonly seen with prostate cancer.This further leads to a major cause of distress among these patients, especially in a resource limited setting as ours.
Extreme hypo-fractionation with a total duration of 2 weeks, would offer an opportunity to optimize the therapeutic ratio taking advantage of the potential therapeutic gain due to low alpha/beta for prostate to higher dose/fraction(compared to surrounding organs at risk). Moreover, shortened overall treatment time,would lead to less distressing and early recommencement of their daily activities for the patients,with an obvious impact in improving the quality of life and health costs.
Given the potential positive economic impact with shorter duration treatment with similar clinical outcomes and probable similar toxicity profile, SBRT (extreme hypo-fractionation) in prostate cancer is an attractive treatment option, especially in a limited-resource setting and can have a large and positive impact on the patient care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Hypo-fractionation | Active comparator | Radiation: Moderate Hypo-fractionationIn 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). |
| Extreme Hypo-fractionation | Experimental | Radiation: Extreme Hypo-fractionationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate Hypo-fractionation66-68Gy in 25# | Radiation | Moderate Hypo-fractionation |
| Extreme Hypo-fractionationAlso: SBRT35-36.25 Gy in 5# | Radiation | Extreme Hypo-fractionation |
Primary outcome
Biochemical Failure free Survival (BFFS)
Time frame: 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
6 secondary outcomes
Acute toxicity with both treatments.
Time frame: 2 years
Late toxicity with both treatments.
Time frame: 2 years
Prostate cancer specific survival
Time frame: 5 years
Overall Survival
Time frame: 5 years
out of pocket expenditure
Time frame: Baseline, 2 and 5 years
patient reported quality of life
Time frame: baseline and every 6 monthly for five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 32114475Murthy 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.
- Derived from this study: PubMed 42537851Murthy V, Gulati S, Ghosh S, Sable S, Phurailatpam R, Patil D, Mhatre R, Chougle N, Solanki M, Singh M, Verma P, Singh P, Maitre P. Empty-RT: A Phase 2 Trial of Prostate Stereotactic Body Radiation Therapy With an Empty Bladder Approach. Int J Radiat Oncol Biol Phys. 2026 Jul 31:S0360-3016(26)04064-2. doi: 10.1016/j.ijrobp.2026.07.018. Online ahead of print.
- Acute toxicityLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vedang Murthy principal investigator
Tata Memorial Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Hypo-fractionation and Extreme Hypo-fractionation in people with Prostate Adenocarcinoma, run by Tata Memorial Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Failure free Survival (BFFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03561961, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.