Cancer Of ProstatePhase 1NCT03388619
Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy
A Phase 1 study testing Prostate bed with integrated boost, Prostate bed irradiation only and Whole Body Bone Scan in people with Cancer Of Prostate and Prostate Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Sometimes prostate cancer comes back after a person's prostate is removed. In this case, radiation is a common treatment. Radiation kills prostate cancer cells. It can be very effective. It is usually given in short doses almost every day for 6 or 7 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer Of Prostate, Prostate Neoplasms, Prostate Cancer
- What is being tested?
- Prostate bed with integrated boost, Prostate bed irradiation only and Whole Body Bone Scan
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2018to 4 Dec 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate.
- Indications for post-prostatectomy radiation exist:
- Disease progression (detectable prostate-specific antigen (PSA) on two measurements obtained at least one month apart) or
- indications for adjuvant radiation exist (if undetectable PSA): pathologic T3, T4, N+ disease or positive margins (within 1 year of prostatectomy).
- Age greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 (Karnofsky greater than or equal to 60)
Show all 9Show fewer
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Radiation is teratogenic; thus, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and up to 120 days after the last radiation. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
- Human immunodeficiency virus (HIV) positive patients are included if CD4+ (cytotoxic T cells) T-cell count > 200 cells/uL; on stable antiretroviral therapy for > 1 year with HIV viral load <200 copies/mL, and no history of opportunistic infections in > 1 year.
Who cannot join
- Patients who are receiving any other investigational agents concurrently.
- Documented metastases of prostate cancer outside of the pelvis (pelvic lymph nodes are allowed only if within the prostate bed region).
- History of radiation that would overlap with the intended treatment to the prostate bed.
- Known contraindications to radiation such as inflammatory bowel disease, active systemic lupus or scleroderma, or radiation hypersensitivity syndrome (Ataxia Telangiectasia or Fanconi's Anemia)
- Subjects with any coexisting medical or psychiatric condition which, in the opinion of the Investigator likely to interfere with study procedures and/or results.
- Medically indicated use of known radiosensitizing drugs (such as protease inhibitors)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Phase I Trial of Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy
Background:
Sometimes prostate cancer comes back after a person's prostate is removed. In this case, radiation is a common treatment. Radiation kills prostate cancer cells. It can be very effective. It is usually given in short doses almost every day for 6 or 7 weeks. Researchers want to see if a shorter schedule can be as effective. They want to see if that causes the same or fewer side effects. Usually, radiation is used to treat the entire area where the prostate was before surgery. In some patients, an area of tumor can be seen on scans. Researchers are also trying to see if they can give less dose to the area usually treated with radiation if the full dose is given to the tumor seen on scans.
Read more
Objective:
To find the shortest radiation schedule that people can tolerate without strong side effects.
Eligibility:
People at least 18 years old who have had a prostatectomy and will get radiation.
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Blood and urine tests
- Scan that uses a small amount of radiation to make a picture of the body
- Scan that uses a magnetic field to make an image of the body
- Participants will provide documents that confirm their diagnosis.
- Participants may have a scan of the abdomen and pelvis.
Before they start treatment, participants will have another physical exam and blood tests.
Participants will get radiation each day Monday through Friday. Treatment may last 2, 3, or 4 weeks.
Participants may provide a tissue sample from a previous procedure for research.
Participants will answer questions about their general well-being and function.
About 4-5 weeks after they finish radiation treatment, participants will have a follow-up visit. They will be examined and give a blood sample. They will have 6 follow-up visits for the next 2 years.
Read the detailed description
BACKGROUND:
Prostate cancer that recurs after prostatectomy (rising prostate-specific antigen (PSA) with no evidence of metastatic disease is often treated with radiation to the entire prostate bed to a dose of 66-72 Gray (Gy) over 6-7 weeks. This treatment can provide PSA control in approximately 75% of patients but may have associated genitourinary and gastrointestinal toxicity due to irradiation of the rectum, small bowel, and bladder. Imaging of prostate cancer has improved to the extent that recurrent disease is often identified in the prostate bed or in other pelvic sites. The current standard is to irradiate the entire prostate bed to the total dose. This trial will test the tolerability of accelerated treatment designed to yield a similar rate of late toxicity. In addition, in patients with visible tumor, it will test the feasibility of delivering a lower dose to the prostate bed and an integrated boost (simultaneous) to the visible tumor to allow a higher dose to visible tumor than can be delivered with standard approaches.
OBJECTIVE:
- Define the maximum tolerated dose (MTD) hypofractionation of image guided, focally dose escalated post-prostatectomy radiation.
ELIGIBILITY:
- PSA recurrence after prostatectomy or indications for adjuvant radiation after prostatectomy.
- No evidence of distant metastases of prostate cancer (pelvic lymph nodes are allowed).
- Age greater than or equal to 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
DESIGN:
This is a Phase I trial of hypofractionated focal dose escalation with reduced dose prostate bed irradiation using image and pathologic guidance. The prostate bed will be treated with hypofractionated radiation and areas in the prostate bed or pelvis shown to have tumor on biopsy or with advanced imaging studies will be treated with an integrated boost to visible tumor. The treatment duration will be decreased sequentially in three Dose Level groups. Quality of life and functional outcomes such as urine, bowel, and erectile function will be assessed with questionnaires. A maximum of 48 patients will be enrolled.
- Conditions
- Cancer Of Prostate, Prostate Neoplasms, Prostate Cancer, Neoplasms of Prostate, Prostatic Cancer
- Being tested
- Prostate bed with integrated boost, Prostate bed irradiation only, Whole Body Bone Scan, 18F-NaF PET Imaging, CT
- Keywords
- Rising PSA, No evidence of metastatic disease, Entire Prostate Bed, Quality of Life, Irradiation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate bed with integrated boostRadiation
Radiation will be delivered at an escalated dose to areas of recurrent prostate cancer identified on imaging and a reduced dose will be delivered to the entire prostate bed.
Prostate bed irradiation onlyRadiation
Radiation will be delivered to the prostate bed only.
Whole Body Bone ScanDiagnostic test
At screening, if required by clinician.
18F-NaF PET ImagingDiagnostic test
Also called Fluorine 18-sodium fluoride positron emission tomography
At screening, if required by clinician.
CTDiagnostic test
Also called Computed tomography
Computed tomography of the abdomen and pelvis if clinically indicated at screening, with oral and intravenous contrast.
mpMRIDiagnostic test
Also called Multiparametric magnetic resonance imaging
mpMRI of the prostate bed at screening and 6 month follow up.
ADTDrug
Also called androgen deprivation therapy
After enrollment if clinically indicated (i.e., anti-androgen, gonadotropin releasing hormone agonist, or combination of both).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1/Prostate Bed with Integrated Boost | Experimental | Prostate bed with integrated boost. Receives: Radiation: Prostate bed with integrated boost; Diagnostic Test: Whole Body Bone Scan; Diagnostic Test: 18F-NaF PET Imaging; Diagnostic Test: CT; Diagnostic Test: mpMRI; Drug: ADT |
| Arm 2/Prostate Bed Irradiation Only | Experimental | Prostate bed irradiation only. Receives: Radiation: Prostate bed irradiation only; Diagnostic Test: Whole Body Bone Scan; Diagnostic Test: 18F-NaF PET Imaging; Diagnostic Test: CT; Diagnostic Test: mpMRI; Drug: ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Gray (Gy)
Maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation is defined as the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of treatment. A DLT is defined as any of the following: Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days with appropriate medical management. Other grade 3 in-field toxicities attributable to radiation that does not resolve to Grade 2 or less within 4 days with appropriate medical management. And delays of more than one week in completing radiation treatment due to toxicity.
Measured: 3 weeks after radiation
Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Fractions
Maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation is defined as the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of treatment. A DLT is defined as any of the following: Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days with appropriate medical management. Other grade 3 in-field toxicities attributable to radiation that does not resolve to Grade 2 or less within 4 days with appropriate medical management. And delays of more than one week in completing radiation treatment due to toxicity.
Measured: 3 weeks after radiation
Secondary outcomes (5)
Biochemical Progression Free Survival (bPFS)
bPFS is defined as the percent of participants without evidence of (prostate-specific antigen) PSA progression or death. PSA progression (also known as biochemical failure) is defined based on elevation of PSA above 0.1 ng/dL. Kaplan-Meier survival analysis will be used to report bPFS.
Measured: 1 and 2 years after treatment
Changes in Erectile Dysfunction QOL Scores During and After Treatment Measured by the Sexual Health Inventory for Men (SHIM)
Changes before and after treatment with prostate bed radiation in participant reported outcomes (Sexual Health Inventory for Men (SHIM). The QOL scores will be summarized at baseline and after treatment. Linear mixed effects model will be used to model quality of life scores at baseline and during and after treatment in which random intercept and random slope are used to account for participant-specific trajectory of QOL scores. The SHIM is a 5-question quiz used to identify erectile dysfunction and assess its severity. The composite score is generated by adding the score for each question. The total score can range from 1-25. Higer values represent better erectile function.
Measured: Baseline compared to 24 months after treatment
Changes of American Urologic Association (AUA) Symptom Index Quality of Life (QOL) Scores During and After Treatment
Changes of QOL scores during and after treatment with prostate bed radiation in American Urologic Association (AUA) Symptom Index. The QOL scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model quality of life scores at baseline and during and after treatment in which random intercept and random slope are used to account for participant-specific trajectory of QOL scores. The AUA Symptom Index is a 7-question quiz used to identify urinary symptoms and assess severity. Each question is scored based on the frequency of different urinary symptoms. The composite score is generated by adding the score for each question. The total score can range from 0-35. Lower values represent less symptoms.
Measured: Baseline compared to 24 months after treatment
Changes of Expanded Prostate Cancer Index Composite (EPIC-26) Quality of Life (QOL) Scores During and After Treatment
Changes of QOL scores during and after treatment of focally dose escalated prostate stereotactic body radiation therapy on participant(pt) reported outcomes, EPIC-26 in pts previously treated with radiotherapy. The QOL scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model QOL scores at baseline and during and after treatment in which random intercept and random slope are used to account for pt-specific trajectory of QOL scores. The EPIC-26 is a shortened, validated questionnaire used to assess health related QOL in individuals with prostate cancer. EPIC26 measures sexual function, bowel function, hormone therapy side effects, urinary incontinence, and urinary irritative symptoms. The survey has 26 individual items that have 4 to 5 response options that reflect a range of function from poor to excellent. EPIC26 uses a Likert scale for each item, and scores are transformed to a 0-100 scale, with higher scores indicating better HRQOL.
Measured: Baseline compared to 24 months after treatment
Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research
Grade 2-5 serious and/or non-serious adverse events attributable to protocol treatment. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 2 is moderate. Grade 3 is serious. Grade 4 is life-threatening. And Grade 5 is death related to adverse event.
Measured: 3 weeks after radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start17 Jan 2018
- Primary completion29 Dec 2023
- Study completion4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer Of ProstateStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Deborah Citrin, M.D., National Cancer Institute (NCI)
- Investigators
- Deborah E Citrin, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388619
- Sponsor's protocol ID
- 180028
- Other IDs
- 18-C-0028
- Status last verified
- Aug 2026
- First submitted
- 30 Dec 2017
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
Publications
Shaikh T, Li T, Handorf EA, Johnson ME, Wang LS, Hallman MA, Greenberg RE, Price RA Jr, Uzzo RG, Ma C, Chen D, Geynisman DM, Pollack A, Horwitz EM. Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):722-731. doi: 10.1016/j.ijrobp.2016.12.034. Epub 2016 Dec 28.
PubMed 28244407Christie DR, Sharpley CF, Bitsika V. Why do patients regret their prostate cancer treatment? A systematic review of regret after treatment for localized prostate cancer. Psychooncology. 2015 Sep;24(9):1002-11. doi: 10.1002/pon.3776. Epub 2015 Mar 1.
PubMed 25728586Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20.
PubMed 27339115
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy
- ClinicalTrials.gov ID
- NCT03388619
- Acronym / sponsor ID
- 180028
- Conditions
- Cancer Of Prostate, Prostate Neoplasms, Prostate Cancer, Neoplasms of Prostate, Prostatic Cancer
- Keywords
- Rising PSA, No evidence of metastatic disease, Entire Prostate Bed, Quality of Life, Irradiation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Posted 14 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Sometimes prostate cancer comes back after a person's prostate is removed. In this case, radiation is a common treatment. Radiation kills prostate cancer cells. It can be very effective. It is usually given in short doses almost every day for 6 or 7 weeks. Researchers want to see if a shorter schedule can be as effective. They want to see if that causes the same or fewer side effects. Usually, radiation is used to treat the entire area where the prostate was before surgery. In some patients, an area of tumor can be seen on scans. Researchers are also trying to see if they can give less dose to the area usually treated with radiation if the full dose is given to the tumor seen on scans.
Objective:
To find the shortest radiation schedule that people can tolerate without strong side effects.
Eligibility:
People at least 18 years old who have had a prostatectomy and will get radiation.
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Blood and urine tests
- Scan that uses a small amount of radiation to make a picture of the body
- Scan that uses a magnetic field to make an image of the body
- Participants will provide documents that confirm their diagnosis.
- Participants may have a scan of the abdomen and pelvis.
Before they start treatment, participants will have another physical exam and blood tests.
Participants will get radiation each day Monday through Friday. Treatment may last 2, 3, or 4 weeks.
Participants may provide a tissue sample from a previous procedure for research.
Participants will answer questions about their general well-being and function.
About 4-5 weeks after they finish radiation treatment, participants will have a follow-up visit. They will be examined and give a blood sample. They will have 6 follow-up visits for the next 2 years.
Detailed description
BACKGROUND:
Prostate cancer that recurs after prostatectomy (rising prostate-specific antigen (PSA) with no evidence of metastatic disease is often treated with radiation to the entire prostate bed to a dose of 66-72 Gray (Gy) over 6-7 weeks. This treatment can provide PSA control in approximately 75% of patients but may have associated genitourinary and gastrointestinal toxicity due to irradiation of the rectum, small bowel, and bladder. Imaging of prostate cancer has improved to the extent that recurrent disease is often identified in the prostate bed or in other pelvic sites. The current standard is to irradiate the entire prostate bed to the total dose. This trial will test the tolerability of accelerated treatment designed to yield a similar rate of late toxicity. In addition, in patients with visible tumor, it will test the feasibility of delivering a lower dose to the prostate bed and an integrated boost (simultaneous) to the visible tumor to allow a higher dose to visible tumor than can be delivered with standard approaches.
OBJECTIVE:
- Define the maximum tolerated dose (MTD) hypofractionation of image guided, focally dose escalated post-prostatectomy radiation.
ELIGIBILITY:
- PSA recurrence after prostatectomy or indications for adjuvant radiation after prostatectomy.
- No evidence of distant metastases of prostate cancer (pelvic lymph nodes are allowed).
- Age greater than or equal to 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
DESIGN:
This is a Phase I trial of hypofractionated focal dose escalation with reduced dose prostate bed irradiation using image and pathologic guidance. The prostate bed will be treated with hypofractionated radiation and areas in the prostate bed or pelvis shown to have tumor on biopsy or with advanced imaging studies will be treated with an integrated boost to visible tumor. The treatment duration will be decreased sequentially in three Dose Level groups. Quality of life and functional outcomes such as urine, bowel, and erectile function will be assessed with questionnaires. A maximum of 48 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1/Prostate Bed with Integrated Boost | Experimental | Radiation: Prostate bed with integrated boost, Diagnostic Test: Whole Body Bone Scan, Diagnostic Test: 18F-NaF PET Imaging, Diagnostic Test: CT, Diagnostic Test: mpMRI, Drug: ADTProstate bed with integrated boost. |
| Arm 2/Prostate Bed Irradiation Only | Experimental | Radiation: Prostate bed irradiation only, Diagnostic Test: Whole Body Bone Scan, Diagnostic Test: 18F-NaF PET Imaging, Diagnostic Test: CT, Diagnostic Test: mpMRI, Drug: ADTProstate bed irradiation only. |
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)
- Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate.
- Indications for post-prostatectomy radiation exist:
- Age greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 (Karnofsky greater than or equal to 60)
- Ability of subject to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (6 listed)
- Patients who are receiving any other investigational agents concurrently.
- Documented metastases of prostate cancer outside of the pelvis (pelvic lymph nodes are allowed only if within the prostate bed region).
- History of radiation that would overlap with the intended treatment to the prostate bed.
- Known contraindications to radiation such as inflammatory bowel disease, active systemic lupus or scleroderma, or radiation hypersensitivity syndrome (Ataxia Telangiectasia or Fanconi's Anemia)
- Subjects with any coexisting medical or psychiatric condition which, in the opinion of the Investigator likely to interfere with study procedures and/or results.
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 |
|---|---|---|
| Prostate bed with integrated boostRadiation will be delivered at an escalated dose to areas of recurrent prostate cancer identified on imaging and a reduced dose will be delivered to the entire prostate bed. | Radiation | Arm 1/Prostate Bed with Integrated Boost |
| Prostate bed irradiation onlyRadiation will be delivered to the prostate bed only. | Radiation | Arm 2/Prostate Bed Irradiation Only |
| Whole Body Bone ScanAt screening, if required by clinician. | Diagnostic test | Arm 1/Prostate Bed with Integrated Boost, Arm 2/Prostate Bed Irradiation Only |
| 18F-NaF PET ImagingAlso: Fluorine 18-sodium fluoride positron emission tomographyAt screening, if required by clinician. | Diagnostic test | Arm 1/Prostate Bed with Integrated Boost, Arm 2/Prostate Bed Irradiation Only |
| CTAlso: Computed tomographyComputed tomography of the abdomen and pelvis if clinically indicated at screening, with oral and intravenous contrast. | Diagnostic test | Arm 1/Prostate Bed with Integrated Boost, Arm 2/Prostate Bed Irradiation Only |
| mpMRIAlso: Multiparametric magnetic resonance imagingmpMRI of the prostate bed at screening and 6 month follow up. | Diagnostic test | Arm 1/Prostate Bed with Integrated Boost, Arm 2/Prostate Bed Irradiation Only |
| ADTAlso: androgen deprivation therapyAfter enrollment if clinically indicated (i.e., anti-androgen, gonadotropin releasing hormone agonist, or combination of both). | Drug | Arm 1/Prostate Bed with Integrated Boost, Arm 2/Prostate Bed Irradiation Only |
Primary outcome
Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Gray (Gy)
Time frame: 3 weeks after radiation
Maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation is defined as the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of treatment. A DLT is defined as any of the following: Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days with appropriate medical management. Other grade 3 in-field toxicities attributable to radiation that does not resolve to Grade 2 or less within 4 days with appropriate medical management. And delays of more than one week in completing radiation treatment due to toxicity.
Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Fractions
Time frame: 3 weeks after radiation
Maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation is defined as the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of treatment. A DLT is defined as any of the following: Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days with appropriate medical management. Other grade 3 in-field toxicities attributable to radiation that does not resolve to Grade 2 or less within 4 days with appropriate medical management. And delays of more than one week in completing radiation treatment due to toxicity.
5 secondary outcomes
Biochemical Progression Free Survival (bPFS)
Time frame: 1 and 2 years after treatment
Changes in Erectile Dysfunction QOL Scores During and After Treatment Measured by the Sexual Health Inventory for Men (SHIM)
Time frame: Baseline compared to 24 months after treatment
Changes of American Urologic Association (AUA) Symptom Index Quality of Life (QOL) Scores During and After Treatment
Time frame: Baseline compared to 24 months after treatment
Changes of Expanded Prostate Cancer Index Composite (EPIC-26) Quality of Life (QOL) Scores During and After Treatment
Time frame: Baseline compared to 24 months after treatment
Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research
Time frame: 3 weeks after radiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28244407Shaikh T, Li T, Handorf EA, Johnson ME, Wang LS, Hallman MA, Greenberg RE, Price RA Jr, Uzzo RG, Ma C, Chen D, Geynisman DM, Pollack A, Horwitz EM. Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):722-731. doi: 10.1016/j.ijrobp.2016.12.034. Epub 2016 Dec 28.
- Background: PubMed 25728586Christie DR, Sharpley CF, Bitsika V. Why do patients regret their prostate cancer treatment? A systematic review of regret after treatment for localized prostate cancer. Psychooncology. 2015 Sep;24(9):1002-11. doi: 10.1002/pon.3776. Epub 2015 Mar 1.
- Background: PubMed 27339115Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
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Hormone Sensitive Prostate Cancer, Prostate Cancer
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Deborah E Citrin, M.D. principal investigator
National Cancer Institute (NCI)
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 Prostate bed with integrated boost, Prostate bed irradiation only and Whole Body Bone Scan in people with Cancer Of Prostate and Prostate Neoplasms, run by National Cancer Institute (NCI) 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 9 inclusion and 6 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: finished, as of the sponsor's last update on 28 Aug 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?
Yes. Results are posted in the registry (first posted 14 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Gray (Gy) (time frame: 3 weeks after radiation). The study lists 2 primary outcomes in all. 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 NCT03388619, which also lists 3 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 28 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.