Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Vaccines

Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.

dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.

Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine

Hoyoung M Maeng, M.D.

Background:

- Few studies or literature are available about the long-term safety of repeated peptide vaccinations in people over a period of time. Long-term vaccination may be needed to control tumors. Researchers gave a group of men a series of vaccine injections over 2 years. Now they want to give those same men the new version of the vaccine. They want to see if it produces different types of immune responses and also ensure that repeated vaccinations are safe.

Objectives:

- To find out the long-term safety of repeated T-cell receptor alternate reading frame protein (TARP) peptide vaccinations.

Eligibility:

- Men who took part in National Cancer Institute (NCI) protocol 09-C-0139.

Design:

* Participants will be screened with blood tests, scans, physical exam, medical history, and an evaluation of how well they perform everyday activities.
* Participants will have apheresis. Blood will be removed with a needle from one arm. A machine will separate the white blood cells. The blood, minus the white cells, will be returned through a needle in the other arm.
* Participants will have 14 visits. At each visit, they will have a physical exam and blood tests. They will discuss any side effects.
* Participants will get vaccine injections at weeks 3, 6, 9, 12, 15, and 24. The vaccine will be made from the participants own cells.
* Participants will get a Vaccine Report Card to complete after receiving vaccine.
* The study lasts 96 weeks.

TARP

* T-cell receptor gamma alternate reading frame protein (TARP) is an amino acid protein expressed by both normal and malignant prostate cancer tissue; 95% of prostate cancer specimens are positive for TARP expression. TARP is highly expressed in prostate cancers of all Gleason types, in primary as well as metastatic disease, and in hormone sensitive and castrate resistant prostate cancer. Therefore, TARP is an ideal tumor antigen target for a vaccine.
* A prospective, randomized pilot study of 1st generation TARP Peptide vaccination National Cancer Institute (NCI 09-C- 0139) utilizing TARP WT 27-35 and EE29-37-9V peptides was conducted in HLAA\* 0201positive men with stage D0 prostate cancer prostate specific-antigen (PSA) biochemical recurrence) and a PSA doubling time (PSADT) of greater than or equal to 3 months and less than or equal to 15 months. TARP vaccination was found to be immunogenic, safe and well tolerated, with adverse events limited to injection site reactions less than or equal to Grade 2. TARP vaccination was also associated with a decreased slope log PSA compared to pre-vaccination baseline in 72% of subjects reaching 24 weeks and 74% reaching 48 weeks (p=0.0012 and p=0.0004 for overall changes in slope log PSA, respectively); TARP vaccination also resulted in a 50% decrease in calculated tumor growth rate constant: prevaccine g = 0.0042/day, post-vaccine g = 0.0021/day (p=0.003); TARP-specific IFN- \>= enzyme-linked immunosorbent spot (ELISPOT) responses were detected in the majority of subjects but did not correlate with decreases in slope log (PSA).

Multi-Epitope (ME) TARP Vaccine

* The vaccine platform includes the original two 9-mer HLA-A\*0201 binding TARP peptide epitopes (WT27-35 and EE29-37-9V) utilized in NCI 09-C-0139 as well as an additional five 20-mer TARP peptides overlapping by 10 amino acids for a total of 7 peptides that span the amino acid sequence of the entire TARP protein.
* The advantage of this multi-epitope TARP peptide vaccine platform is that the overlapping epitopes cover the entire TARP protein, resulting in potential for induction of a multi-valent anti-TARP response. In addition, these longer synthetic peptides include TARP-specific MHC class II CD4 T lymphocytes (CD4+ T) cell helper epitopes that will allow generation of better cyctotoxic T cells (CD8+ T) cell responses with improved functional avidity and longevity as well as humoral anti-TARP antibody responses.

Study Objectives

Primary Objective:

-To assess the long-term safety of repeated TARP peptide vaccination following the use of a 1st generation bivalent (09-C-0139) and a 2nd generation ME TARP peptide vaccine. Specifically, to document if less than 10% of enrolled patients experience a vaccine-related Grade 3 adverse event (local injection site reactions or systemic reactions).

Eligibility Criteria All Patients

* Males greater than or equal to 18 years of age with histologically confirmed adenocarcinoma of the prostate.
* Prior enrollment in NCI protocol 09-C-0139 with receipt of at least 5 doses of TARP peptide vaccine (i.e. completion of primary vaccination series).
* Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-1 and life expectancy greater than or equal to 1 year.
* Hemoglobin greater than or equal to 10.0 gm/dL, white blood cell (WBC) greater than or equal to 2,500/mm\^3, ALC greater than or equal to 500/ mm\^3, absolute neutrophil count (ANC) greater than or equal to 1,000/mm\^3, platelet

count greater than or equal to 100,000/mm\^3, and prothrombin time (PT)/partial thromboplastin time (PTT) less than or equal to 1.5X upper limit of normal (ULN) unless receiving clinically indicated anticoagulant therapy; serum glutamate-pyruvate transaminase (SGPT)/serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 2.5X ULN, total bilirubin less than or equal to 1.5X ULN; creatinine less than or equal to 1.5X ULN and estimated glomerular filtration rate (eGFR) greater than or equal to 60 ml/min.

* Hepatitis B and C negative (unless the result is consistent with prior vaccination or prior infection with full recovery); human immunodeficiency virus (HIV) negative.
* No use of investigational agents within 4 weeks of study enrollment or use of immunosuppressive or immunomodulating agents within 8 weeks of study entry.
* Standard of care medical management of current prostate cancer disease status by the patients local oncologist e.g., androgen deprivation therapy is allowed.
* Must be able/willing to adhere to protocol requirements and vaccination timeline.

Exclusion Criteria All Patients

* Patients with active infection or other significant or uncontrolled medical illness. Patients with a remote history of asthma or active mild asthma may participate.
* Patients on immunosuppressive therapy including systemic corticosteroid therapy for any reason. Patients receiving inhaled or topical corticosteroids may participate.
* Patients who, in the opinion of the Principal Investigator, have significant medical or psychosocial problems that warrant exclusion.

Study Design

* Open label, prospective, non-randomized, long-term follow-up pilot study of 96 weeks to assess the long-term safety of repeated TARP vaccination in patients that have already received the first generation TARP vaccine. Sample size: N equals 40 maximum.
* All patients will undergo an 18L apheresis for mononuclear cell collection at Week 0.
* All patients will receive a total of 6 doses of autologous ME TARP peptide dendritic cell (DC) vaccine: 20x10\^6 viable cells/dose) delivered intradermally at Weeks 3, 6, 9, 12, 15, and 24.

Long-Term TARP Vaccination Using a Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Previously Vaccinated Men on NCI 09-C-0139

A Pilot Study of Long Term TARP Vaccination Using A Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccine in Previously Vaccinated Men on NCI 09-C-0139.

All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All collected IPD will be shared with collaborators under the terms of collaborative agreements.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v.0). 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.

The number of Grade 3 adverse events probably related to the vaccine treatment. Adverse events were measured using the Common Terminology Criteria for Adverse Events (CTCAE v.4.0). Grade 3 is severe.

"PSA slope log" was calculated using Memorial Sloan Kettering Cancer Center Prostate Cancer Nomograms (http://nomograms.mskcc.org/Prostate/PsaDoublingTime.aspx) Slope log represents the speed of change of a series of values. Thus, it is reported without any units as it is with a concept of ratio. The clinical meaning of PSA slope change would be decrease or increase of the "speed (velocity)" of changes in PSA, not the changes in PSA values. Decreasing PSA slope after the investigational treatment would mean the PSA rise is slower than pre-treatment baseline. Lowered PSA slope has been reported to show a relationship with was reported as related to improved outcomes.

Participants slope log on study 09C0139 are compared with the slope log values for the same participants after receiving the updated ME-TARP vaccines on the current protocol 15C0076 in participants who were not treated with androgen deprivation. PSA slope log was calculated using Memorial Sloan Kettering Cancer Center Prostate Cancer Nomograms (http://nomograms.mskcc.org/Prostate/PsaDoublingTime.aspx) Slope log represents the speed of change of a series of values. Thus, it is reported without any units as it is with a concept of ratio. The clinical meaning of PSA slope change would be decrease or increase of the "speed (velocity)" of changes in PSA, not the changes in PSA values. Decreasing PSA slope after the investigational treatment would mean the PSA rise is slower than pre-treatment baseline. Lowered PSA slope has been reported to show a relationship with was reported as related to improved outcomes.

Measure of reactivity to WT27-35 and EE29-37-9V TARP peptides.

WT27-35 and EE29-37-9V TARP peptide IFN-gamma ELISPOT reactivity.

National Cancer Institute (NCI)

Principal Investigator

Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.

Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine: dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.

Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Hoyoung Maeng

Number of Grade 3 Adverse Events (AEs) Probably Related to the Vaccine Treatment

Weeks 3-24

Weeks 3-48

Study participants who were in biochemically recurrent prostate cancer and not exposed to androgen deprivation therapy for the management of prostate cancer were evaluable for this endpoint.

Change in Slope Log PSA From Pre-study Baseline (-12 Months to Entry on the Current Study) to the Change in Slope Log PSA at Weeks 3-24 and 3-48 Post Multi-Epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) Vaccination

PSA slope log of the participants while on previous study 09C0139 at Weeks 3-24

PSA slope log of the participants while on current study 15C0076 at Weeks 3-24

PSA slope log of the participants while on previous study 09C0139 at Weeks 3-48

PSA slope log of the participants while on current study 15C0076 at Weeks 3-48

The participants who were evaluable for Memorial Sloan Kettering Cancer Center Prostate Cancer Nomograms are reported for this outcome measure.

Change in Slope Log Prostate Specific-antigen (PSA) Versus the Same Change in Slope Log PSA Parameters Following 1st Generation T-cell Receptor Alternate Reading Frame Protein (TARP) Vaccination on Protocol 09-C-0139

Assess Reactivity to WT27-35 and EE29-37-9V T-cell Receptor Alternate Reading Frame Protein (TARP) Peptides

TARP WT27-35 and EE29-37-9V T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Interferon (IFN)-Gamma Enzyme-linked Immunosorbent Spot (ELISpot) Reactivity

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v.0)

Overall Study

Symptoms and General Pathology

Behaviors and Mental Disorders

Neoplasm Metastasis

Quality of Life

Anti-Infective Agents

Androgens

Hormones

Fluorides

Listerine

Sodium Fluoride

Androgen Antagonists

Protective Agents

Hormone Antagonists

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 with integrated boost

Radiation will be delivered to the prostate bed only.

Prostate bed irradiation only

Whole Body Bone Scan

18F-NaF PET Imaging

Computed tomography of the abdomen and pelvis if clinically indicated at screening, with oral and intravenous contrast.

mpMRI of the prostate bed at screening and 6 month follow up.

mpMRI

After enrollment if clinically indicated (i.e., anti-androgen, gonadotropin releasing hormone agonist, or combination of both).

Deborah E Citrin, M.D.

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.

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.

Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy

A Phase I Trial of Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy

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).

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). 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.

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 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.

bPFS is defined as the duration of time from start of treatment to time of prostate-specific antigen (PSA) progression or death, whichever occurs first. PSA progression (also known as biochemical failure) is defined based on elevation of PSA beyond 0.1 ng/dL. Kaplan-Meier survival analysis and effects of clinical variables on bPFS will be assessed by the Cox proportional hazards model.

The quality-of-life 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 quality-of-life scores.

Participants completed a 6-question questionnaire to assess erectile dysfunction.

The AUA-SI is used to measure radiation morbidity and to make treatment decisions.

Participants complete a form to assess negative mood (i.e., sadness, guilt), views of self (i.e., self-criticism, worthlessness) social cognition (loneliness, interpersonal alienation), decreased positive effect, and decreased engagement (loss of interest, meaning, and purpose) and are scored using item-level calibrations.

Participants complete a form and rate anxiety such as fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness).

Participants complete a form to assess positive psychosocial (emotional and social) outcomes of illness.

The DRS is a 5-item scale measuring distress or remorse after a health case decision. The score correlated with satisfaction with the decision (r=-0.40 to -0.60), decisional conflict (r=0.31 to 0.52), and overall rated quality of life (r=-0.25 to -0.27).

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.

Investigator

LEVEL 1/COHORT 1: Recurrent tumor visible; prostate bed with integrated boost. 20 fractions: Dose to prostate bed 45.8 Gray (Gy) in 2.29 Gy fractions; Dose to tumor 60.4 Gy in 3.02 Gy fractions.

LEVEL 1/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 20 Fractions

LEVEL 2/COHORT 1: Recurrent tumor visible, prostate bed with integrated boost. 15 fractions: Dose to prostate bed 41.85 Gray (Gy) in 2.79 Gy fractions; Dose to tumor 54.6 Gy in 3.64 Gy fractions.

LEVEL 2/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 15 Fractions

LEVEL 3/COHORT 1: Recurrent tumor visible, prostate bed with integrated boost. 10 fractions: Dose to prostate bed 36.4 Gray (Gy) in 3.64 Gy fractions; Dose to tumor 47.1 Gy in 4.71 Gy fractions.

LEVEL 3/COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions

LEVEL 1/COHORT 2: Recurrent tumor NOT visible, prostate bed irradiation only. 20 fractions: Dose to prostate bed 56.4 Gray (Gy) in 2.82 Gy fractions.

LEVEL 1/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions

LEVEL 2/COHORT 2: Recurrent tumor NOT visible, prostate bed irradiation only. 15 fractions: Dose to prostate bed 51.2 Gray (Gy) in 3.41 Gy fractions.

LEVEL 2/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions

LEVEL 3/COHORT 2: Recurrent tumor NOT visible, prostate bed irradiation only. 10 fractions: Dose to prostate bed 44.2 Gray (Gy) in 4.42 Gy fractions.

LEVEL 3/COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions

LEVEL 1/ COHORT 1: Recurrent tumor visible; prostate bed with integrated boost. 20 fractions: Dose to prostate bed 45.8 Gray (Gy) in 2.29 Gy fractions; Dose to tumor 60.4 Gy in 3.02 Gy fractions.

LEVEL 1/ COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 20 Fractions

LEVEL 2/ COHORT 1: Recurrent tumor visible, prostate bed with integrated boost. 15 fractions: Dose to prostate bed 41.85 Gray (Gy) in 2.79 Gy fractions; Dose to tumor 54.6 Gy in 3.64 Gy fractions.

LEVEL 2/ COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 15 Fractions

LEVEL 3/ COHORT 1: Recurrent tumor visible, prostate bed with integrated boost. 10 fractions: Dose to prostate bed 36.4 Gray (Gy) in 3.64 Gy fractions; Dose to tumor 47.1 Gy in 4.71 Gy fractions.

LEVEL 3/ COHORT 1: Recurrent Tumor Visible; Prostate Bed With Integrated Boost - 10 Fractions

LEVEL 1/ COHORT 2: Recurrent tumor NOT visible, prostate bed irradiation only. 20 fractions: Dose to prostate bed 56.4 Gray (Gy) in 2.82 Gy fractions.

LEVEL 1/ COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 20 Fractions

LEVEL 2/ COHORT 2: Recurrent tumor NOT visible, prostate bed irradiation only. 15 fractions: Dose to prostate bed 51.2 Gray (Gy) in 3.41 Gy fractions.

LEVEL 2/ COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 15 Fractions

LEVEL 3/ COHORT 2: Recurrent tumor NOT visible, prostate bed irradiation only. 10 fractions: Dose to prostate bed 44.2 Gray (Gy) in 4.42 Gy fractions.

LEVEL 3/ COHORT 2: Recurrent Tumor NOT Visible; Prostate Bed Irradiation Only - 10 Fractions

Total

Dr. Deborah E. Citrin

Dose to prostate bed

Dose to tumor

All participants with recurrent tumor visible assessed for MTD.

Level 1 Cohort 1, Level 2 Cohort 1, and Level 3 Cohort 1:

Recurrent tumor visible, prostate bed with integrated boost. 10 fractions: Dose to prostate bed 36.4 Gray (Gy) in 3.64 Gy fractions; Dose to tumor 47.1 Gy in 4.71 Gy fractions.

All Participants With Recurrent Tumor Visible

All participants with recurrent tumor NOT visible assessed for MTD.

Level 1 Cohort 2, Level 2 Cohort 2, and Level 3 Cohort 2:

Recurrent tumor NOT visible, prostate bed irradiation only. 10 fractions: Dose to prostate bed 44.2 Gray (Gy) in 4.42 Gy fractions.

All Participants With Recurrent Tumor NOT Visible

12/30 expansion group participants (6 in Recurrent Tumor Visible: Level 3 Cohort 1, and Recurrent Tumor NOT Visible: Level 3 Cohort 2) were not assessed for MTD and included in the analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Long-Term TARP Vaccination Using a Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Previously Vaccinated Men on NCI 09-C-0139	NCT02362464	Prostatic Neopl... Neoplasms of Pr... Prostate Cancer Cancer Of Prost... Stage D0 Prosta...	Multi-epitope (...	18 Years -	National Institutes of Health Clinical Center (CC)
Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy	NCT03388619	Cancer Of Prost... Prostate Neopla... Prostate Cancer Neoplasms of Pr... Prostatic Cance...	Prostate bed wi... Prostate bed ir... Whole Body Bone... 18F-NaF PET Ima... CT mpMRI ADT	18 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for neoplasms of prostate