Prostate CancerPhase 1PROSINTNCT04147806
A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer
A Phase 1 study testing IGRT 45 Gy in 5 fractions of 9 Gy, IGRT 24 Gy single dose and Dexamethasone in people with Prostate Cancer, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
The present study evaluates clinical outcomes and treatment-related toxicity following definitive ultra-high dose external beam radiotherapy delivered with two different regimens in patients with intermediate-risk adenocarcinoma of the prostate. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- IGRT 45 Gy in 5 fractions of 9 Gy, IGRT 24 Gy single dose and Dexamethasone
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to Jul 2026
- Phase
- Phase 1
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed study specific informed consent form;
- Histologic confirmation of adenocarcinoma of the prostate by biopsy;
- PSA ≤ 20 ng/mL;
- Gleason score 7;
- Staging MRI must confirm American Joint Committee on Cancer (AJCC) stage T1, T2a, T2b or T2c;
- No direct evidence of regional or distant metastases after appropriate staging studies;
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- Age ≥ 50;
- Performance Status 0-2;
- Internation Prostate Symptom Score score must be ≤ 15 (alpha blockers allowed);
- CT scan or Ultrasound-based volume estimation of prostate gland ≤ 100 grams;
Who cannot join
- Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies
- Prior invasive malignancy unless disease-free for a minimum of 5 years
- Tumour Clinical stage T3 or T4 on MRI
- PSA > 20 ng/mL
- Gleason score > 7
- Previous pelvic radiotherapy
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- Previous surgery for prostate cancer
- Previous transurethral resection of the prostate (TURP)
- History of Crohn's Disease or Ulcerative Colitis
- Previous significant urinary obstructive symptoms
- Significant psychiatric illness
- Ultrasound or CT estimate of prostate volume > 100 grams
- Severe, active co-morbidity
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467-2490
About this study
The present study evaluates clinical outcomes and treatment-related toxicity following definitive ultra-high dose external beam radiotherapy delivered with two different regimens in patients with intermediate-risk adenocarcinoma of the prostate. Modern computer-driven technology enables the implementation of ultra-high hypofractionated Image-Guided Radiotherapy (IGRT) safely.
Prostate cancer patients classified according to the current National Comprehensive Cancer Network (NCCN) guidelines as intermediate risk (biopsy Gleason score of 7 and/or Prostate Specific Antigen (PSA) level >10 and ≤20 ng/mL and/or Stage T1, T2a, T2b or T2c) are eligible for this study.
Read more
Patients will undergo IGRT with volumetric intensity-modulated arc radiotherapy (VMAT) with state-of-the-art treatment-planning and quality assurance procedures. Emphasis is placed on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility. A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility, while a urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking. Previously untreated patients with intermediate-risk prostate cancer will be prospectively randomized to receive either 45 Gy in five fractions of 9 Gy each vs. 24 Gy in a single-dose.
Patients will be followed at one month post-treatment and every 3 months for up to 12 months (+/- 4 weeks) and every 6 months thereafter. Acute and chronic toxicity evaluations will focus on urinary, rectal and sexual functions and will be assessed through validated questionnaires. Serum PSA values will be regularly acquired during follow-up. A multiparametric MRI will be performed at baseline, 6, 12 and 24 months following intervention. Additionally, a post-treatment diffusion-weighted MRI (DW-MRI) will be performed within 15 minutes of the first treatment, to measure early physiologic changes, such as perfusion and ischemia, that may correlate with clinically relevant end-points. Post-treatment prostate needle biopsies will be obtained at 24 months to evaluate pathologic response to therapy. The study will be continuously monitored for a minimum of 5 years. In the event unexpected severe (grade ≥3) toxicities are observed in any one of the treatment arms, the study will be terminated according to the stopping rule >3/first 15 patients.
Read the detailed description
This is open label feasibility study where patients enrolled in the study will undergo image-guided, intensity-modulated radiotherapy using the same equipment, techniques, and treatment-planning procedures as currently practiced at CCU. Eligible patients will receive either 45 Gy in 5 sessions each of 9 Gy delivered in one week (arm A) or 24 Gy in 1 session (arm B) to assess the dose limiting toxicities in the two groups. Patients will be randomized to arm A or arm B.
Dose limiting toxicity (DLT) is defined as any Grade 3 urinary or rectal toxicity, based on NCI CTCAE v4.0, observed within 3 months of completion of protocol radiation. If, at any point in the conduct of the trial, DLTs are observed in three patients in a study arm, accrual to that arm will be terminated.
There are three aspects of this study that will be different from the currently used standard treatment for definitive external beam treatment of prostate cancer:
- The dose-fractionation scheme, as per the treatment arm.
- Acquisition of a set of prostate biopsies at 24 months post treatment
- Examination of imaging response based on multi-parametric MRI
- Conditions
- Prostate Cancer
- Being tested
- IGRT 45 Gy in 5 fractions of 9 Gy, IGRT 24 Gy single dose, Dexamethasone, Tamsulosin
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGRT 45 Gy in 5 fractions of 9 GyRadiation
Administration of 9 Gy in five consecutive days, to a total dose of 45 Gy radiation
IGRT 24 Gy single doseRadiation
Administration of a single dose of 24 Gy in one session
DexamethasoneDrug
Also called Dexasone
4 mg by mouth on treatment days only
TamsulosinDrug
Also called Flomax Relief
0.4 mg by mouth daily starting the day of simulation and until 2 weeks post-treatment.
| Study group | Role | What they receive |
|---|---|---|
| IGRT 45 Gy in 5 fractions of 9 Gy | Active comparator | Hypofractionated IGRT at a prescription dose of 45 Gy in 5 fractions of 9 Gy delivered in five consecutive days Receives: Radiation: IGRT 45 Gy in 5 fractions of 9 Gy; Radiation: IGRT 24 Gy single dose; Drug: Dexamethasone; Drug: Tamsulosin |
| IGRT 24 Gy single dose | Experimental | single fraction IGRT at a prescription dose of 24 Gy Receives: Radiation: IGRT 45 Gy in 5 fractions of 9 Gy; Radiation: IGRT 24 Gy single dose; Drug: Dexamethasone; Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
The number of patients with treatment-related DLT will be based on the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v3.0 criteria. DLT is defined as any Grade 3 genitourinary or gastrointestinal toxicity based on NCI-CTCAE criteria observed within 3 months of completion of protocol radiation therapy. The number of patients exhibiting DLT will be summarized by study arm.
Measured: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months following completion of treatment
Secondary outcomes (5)
Change in Post-treatment Serum Prostate Specific Antigen (PSA) concentrations
Serum blood draws will be collected for determination of PSA concentrations at the specified timepoints during clinical follow-up and analyzed by immunoassay. Change in serum PSA concentrations from baseline will be summarized in units of ng/mL and reported by study arm using basic descriptive statistics.
Measured: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months following completion of treatment
Post-treatment Prostate Specific Antigen Relapse-free Survival (PSA-RFS)
Post-treatment PSA-RFS will be assessed at the specified timepoints during clinical follow-up. PSA-RFS will be defined as the time from the end of radiation therapy to PSA relapse or last follow-up and based on the revised American Society for Therapeutic Radiology and Oncology (ASTRO) consensus and Houston definition. The key criterion for biochemical failure as defined by the updated ASTRO definition is a PSA level at or greater than the absolute nadir PSA level plus 2 ng/mL dated at the time of failure. PSA-RFS will be assessed by Kaplan-Meier estimation and summarized by arm at each timepoint.
Measured: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months following completion of treatment
Pathological Response Rate
Pathological response rate will be evaluated via repeat biopsy samples. For purposes of this study, pathological response rate will be summarized using sample proportions (percentages) and confidence intervals. Pathologic response rates will be divided into 3 categories as per current institutional standard and summarized based on these categories:
- Prostate adenocarcinoma without typical radiation induced changes;
- Prostate adenocarcinoma with radiation induced changes; and
- No evidence of adenocarcinoma.
Measured: 24-36 months following completion of treatment
Quality of life assessment based on International Prostate Symptom Score (IPSS)
The IPSS index will be utilized to measure the severity of lower urinary tract symptoms. The IPSS is a 7-item questionnaire designed to assess urinary functioning; specifically, urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Each of the 7 symptom questions is rated on a 6-point Likert scale ranging from 0-5, for an overall possible scoring range of 0-35, with higher scores indicating more difficulty in urinary functioning. Severity thresholds are as follows: 0-7 indicates mild symptoms; 8-19 indicates moderate symptoms; 20-35 indicates severe symptoms. Results will be summarized by arm for each timepoint using basic descriptive statistics.
Measured: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months following completion of treatment
Quality of life assessment based on International Index of Erectile Function (IIEF)
Qualify of life will also be assessed using the IIEF questionnaire. The IIEF is a 15-item questionnaire that assesses five distinct factors (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall sexual satisfaction). Each of the 15 questions is rated on 6-point Likert scale ranging from 0-5, for an overall possible scoring range of 0-75. Higher scores are indicative of increased erectile function. Results will be summarized by arm for each timepoint using basic descriptive statistics.
Measured: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months following completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Aug 2016
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madhur Garg, MD, Principal investigator, Associate Clinical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147806
- Sponsor's protocol ID
- 2016-6545
- Acronym
- PROSINT
- Status last verified
- Mar 2026
- First submitted
- 10 Oct 2019
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT04147806
- Acronym / sponsor ID
- PROSINT / 2016-6545
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 1 Nov 2019 (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.
The present study evaluates clinical outcomes and treatment-related toxicity following definitive ultra-high dose external beam radiotherapy delivered with two different regimens in patients with intermediate-risk adenocarcinoma of the prostate. Modern computer-driven technology enables the implementation of ultra-high hypofractionated Image-Guided Radiotherapy (IGRT) safely.
Prostate cancer patients classified according to the current National Comprehensive Cancer Network (NCCN) guidelines as intermediate risk (biopsy Gleason score of 7 and/or Prostate Specific Antigen (PSA) level >10 and ≤20 ng/mL and/or Stage T1, T2a, T2b or T2c) are eligible for this study.
Patients will undergo IGRT with volumetric intensity-modulated arc radiotherapy (VMAT) with state-of-the-art treatment-planning and quality assurance procedures. Emphasis is placed on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility. A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility, while a urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking. Previously untreated patients with intermediate-risk prostate cancer will be prospectively randomized to receive either 45 Gy in five fractions of 9 Gy each vs. 24 Gy in a single-dose.
Patients will be followed at one month post-treatment and every 3 months for up to 12 months (+/- 4 weeks) and every 6 months thereafter. Acute and chronic toxicity evaluations will focus on urinary, rectal and sexual functions and will be assessed through validated questionnaires. Serum PSA values will be regularly acquired during follow-up. A multiparametric MRI will be performed at baseline, 6, 12 and 24 months following intervention. Additionally, a post-treatment diffusion-weighted MRI (DW-MRI) will be performed within 15 minutes of the first treatment, to measure early physiologic changes, such as perfusion and ischemia, that may correlate with clinically relevant end-points. Post-treatment prostate needle biopsies will be obtained at 24 months to evaluate pathologic response to therapy. The study will be continuously monitored for a minimum of 5 years. In the event unexpected severe (grade ≥3) toxicities are observed in any one of the treatment arms, the study will be terminated according to the stopping rule >3/first 15 patients.
Detailed description
This is open label feasibility study where patients enrolled in the study will undergo image-guided, intensity-modulated radiotherapy using the same equipment, techniques, and treatment-planning procedures as currently practiced at CCU. Eligible patients will receive either 45 Gy in 5 sessions each of 9 Gy delivered in one week (arm A) or 24 Gy in 1 session (arm B) to assess the dose limiting toxicities in the two groups. Patients will be randomized to arm A or arm B.
Dose limiting toxicity (DLT) is defined as any Grade 3 urinary or rectal toxicity, based on NCI CTCAE v4.0, observed within 3 months of completion of protocol radiation. If, at any point in the conduct of the trial, DLTs are observed in three patients in a study arm, accrual to that arm will be terminated.
There are three aspects of this study that will be different from the currently used standard treatment for definitive external beam treatment of prostate cancer:
- The dose-fractionation scheme, as per the treatment arm.
- Acquisition of a set of prostate biopsies at 24 months post treatment
- Examination of imaging response based on multi-parametric MRI
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGRT 45 Gy in 5 fractions of 9 Gy | Active comparator | Radiation: IGRT 45 Gy in 5 fractions of 9 Gy, Radiation: IGRT 24 Gy single dose, Drug: Dexamethasone, Drug: TamsulosinHypofractionated IGRT at a prescription dose of 45 Gy in 5 fractions of 9 Gy delivered in five consecutive days |
| IGRT 24 Gy single dose | Experimental | Radiation: IGRT 45 Gy in 5 fractions of 9 Gy, Radiation: IGRT 24 Gy single dose, Drug: Dexamethasone, Drug: Tamsulosinsingle fraction IGRT at a prescription dose of 24 Gy |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed study specific informed consent form;
- Histologic confirmation of adenocarcinoma of the prostate by biopsy;
- PSA ≤ 20 ng/mL;
- Gleason score 7;
- Staging MRI must confirm American Joint Committee on Cancer (AJCC) stage T1, T2a, T2b or T2c;
Key exclusion criteria (13 listed)
- Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies
- Prior invasive malignancy unless disease-free for a minimum of 5 years
- Tumour Clinical stage T3 or T4 on MRI
- PSA > 20 ng/mL
- Gleason score > 7
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 |
|---|---|---|
| IGRT 45 Gy in 5 fractions of 9 GyAdministration of 9 Gy in five consecutive days, to a total dose of 45 Gy radiation | Radiation | IGRT 24 Gy single dose, IGRT 45 Gy in 5 fractions of 9 Gy |
| IGRT 24 Gy single doseAdministration of a single dose of 24 Gy in one session | Radiation | IGRT 24 Gy single dose, IGRT 45 Gy in 5 fractions of 9 Gy |
| DexamethasoneAlso: Dexasone4 mg by mouth on treatment days only | Drug | IGRT 24 Gy single dose, IGRT 45 Gy in 5 fractions of 9 Gy |
| TamsulosinAlso: Flomax Relief0.4 mg by mouth daily starting the day of simulation and until 2 weeks post-treatment. | Drug | IGRT 24 Gy single dose, IGRT 45 Gy in 5 fractions of 9 Gy |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months following completion of treatment
The number of patients with treatment-related DLT will be based on the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v3.0 criteria. DLT is defined as any Grade 3 genitourinary or gastrointestinal toxicity based on NCI-CTCAE criteria observed within 3 months of completion of protocol radiation therapy. The number of patients exhibiting DLT will be summarized by study arm.
5 secondary outcomes
Change in Post-treatment Serum Prostate Specific Antigen (PSA) concentrations
Time frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months following completion of treatment
Post-treatment Prostate Specific Antigen Relapse-free Survival (PSA-RFS)
Time frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months following completion of treatment
Pathological Response Rate
Time frame: 24-36 months following completion of treatment
Quality of life assessment based on International Prostate Symptom Score (IPSS)
Time frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months following completion of treatment
Quality of life assessment based on International Index of Erectile Function (IIEF)
Time frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months following completion of treatment
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 3 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Madhur Garg, MD principal investigator
Associate Clinical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IGRT 45 Gy in 5 fractions of 9 Gy, IGRT 24 Gy single dose and Dexamethasone in people with Prostate Cancer, run by Albert Einstein College of Medicine at 1 site in United States.
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 10 inclusion and 13 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 3 Apr 2026. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dose-limiting toxicity (DLT) (time frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months following completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.