Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Technetium Tc 99m Medronate

Subjects with biopsy proven prostate cancer, no prior local therapy, and:

PSA ≥ 10 ng/dl, or Gleason Sum ≥ 4+3, or clinical stage ≥cT2c Staging by 99mTc-MDP or NaF PET bone scan, and Diagnostic CT (pelvis) or MRI will undergo 18F DCFPyL PET CT scan.

18F-DCFPyL

Jafari Lida, M.D.

Nicholas G Nickols, M.D., Ph.D.

Lida Jafari, M.D.

Primary Objective:

The primary objective of this study is to assess the efficacy of 18F-DCFPyL PET-CT for initial staging of prostate cancer in Veterans compared to conventional imaging (99mTc-MDP bone scan and Diagnostic CT or MRI). The primary clinical endpoint of our study is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging.

Secondary Objectives:

Frequency of the change in primary treatment plan after initial staging.

This is a single arm Phase II clinical trial in Veterans with prostate cancer, no prior local therapy, who are at risk of having metastatic disease (PSA greater than 10, or Gleason Score greater than or equal to 4+3, or clinical stage greater than or equal to T2c). Veterans who are planned to undergo or have recently undergone conventional, routine care initial staging scans for prostate cancer (99mTc-MDP or NaF PET bone scan and diagnostic CT or MRI of pelvis) will also receive a 18F-DCFPyL PET-CT scan. The primary endpoint is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT scan identifies evidence of M1 disease at initial staging.

18F-DCFPyL PET-CT Scan and Prostate Cancer

A Novel 18F-DCFPyL PET-CT Scan for Diagnosis and Management of Prostate Cancer

University of California, Los Angeles

Lida Jafari

Nuclear Medicine Physician

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

Pharmaceutical Solutions

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Direct injection of NanoPac at 15 mg/mL at a volume not to exceed the volume of the prostate cancer lesion (no more than 10% of total prostate volume). NanoPac will be administered on up to three occasions, with at least 28 days between each dose.

NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles. For clinical administration, the NanoPac powder in vial is suspended with Sterile Reconstitution Solution (1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP) and then further diluted with 0.9% Sodium Chloride for Injection, USP, to achieve the final clinical formulation.

NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension

Shelagh Verco, PhD

This study evaluates the use of NanoPac injected directly into the prostate lesion in men with prostate cancer.

NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, this submicron particle paclitaxel will be injected directly into the prostate lesion in men with prostate cancer scheduled for prostatectomy on up to three different occasions. All subjects in the study will receive NanoPac and will be evaluated to see if NanoPac is safe, well-tolerated, and has an impact on prostate cancer.

Open-label, single group, safety, efficacy, and pharmacokinetic study.

Trial of NanoPac Focal Therapy for Prostate Cancer

Phase 2 Trial of NanoPac Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy

Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)

Prostate tissue samples obtained from a biopsy performed prior to baseline and prostatectomy. Histologic evaluation of these samples will be used to determine the Gleason score, and the results at baseline and Day 92 will be used to evaluate the tumor response to NanoPac. The Gleason score is calculated by adding together the two grades of cancer cells that make up the largest areas of the biopsied tissue sample. The Gleason score usually ranges from 6 to 10. The lower the Gleason score, the more the cancer cells look like normal cells and are likely to grow and spread slowly; a higher Gleason score is likely to indicate a worse outcome. The Gleason score is used to help plan treatment and determine prognosis.

Tissues excised from the dominant lesion during prostatectomy (Day 92) will be evaluated for the percentage considered adenocarcinoma and compared to biopsy sample obtained at baseline.

The proportion of subjects with local invasion as measured by mpMRI at the final study visit will be compared to screening (baseline)

Tumor response to treatment with NanoPac will be determined by evaluating the change in image volume with multiparametric MRI (mpMRI) obtained prior to consent and again at the final study visit.

PSA density (PSAD), is a calculation of the serum PSA level divided by the volume of the prostate gland. PSA density has been used as a prognostication tool in helping decide treatment approach. PSA density measured at the final study visit will be compared to screening (baseline)

The Prostate Imaging Reporting and Data System (PI-RADS) assessment uses a five-point scale based on the probability that a combination of mpMRI findings on T2 weighting (T2W), Diffusion Weighted Imaging (DWI), and Dynamic Contrast Enhancement (DCE) correlates with the presence of a clinically significant cancer in the prostate gland. A PI-RADS score of 1 is considered to be most probably benign and a score of 5 is considered to be highly suspicious of prostate malignancy. PI-RADS score will be measured at screening (baseline) and at the final study visit.

Optional PSMA PET scan performed prior to first NanoPac injection and prior to prostatectomy

Pharmacokinetic samples will be obtained on days of NanoPac injection and other clinic visits.

Ejaculate samples will be collected for analysis of the presence or absence of paclitaxel.

At the time of prostatectomy, available tissues including the tumor, the ipsilateral lobe of the prostate, the contralateral lobe of the prostate, and pelvic lymph nodes, will be evaluated for the presence or absence of paclitaxel

US Biotest, Inc.

NanOlogy, LLC

Direct injection of NanoPac at 15 mg/mL at a volume not to exceed the volume of the prostate cancer lesion (no more than 10% of total prostate volume). NanoPac will be administered on up to three occasions, with at least 28 days between each dose.

NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles. For clinical administration, the NanoPac powder in vial is suspended with Sterile Reconstitution Solution (1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP) and then further diluted with 0.9% Sodium Chloride for Injection, USP, to achieve the final clinical formulation.

NanoPac

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Study was terminated early due to lack of enrollment.

Gere S. diZerega, MD

Number of Participants With Treatment Emergent Adverse Events

Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score)

Tumor Response Based on Change in Percentage of Sample Considered Adenocarcinoma

Tumor Invasion Into Surrounding Tissues

Tumor Response Based on Change in Image Volume on mpMRI

Change in PSA Density

Change in PI-RADS Score

Effect on Tumor Presence in Lymph Nodes

Concentration of Paclitaxel in the Systemic Circulation Post-injection

Presence or Absence of Paclitaxel in Ejaculate

Presence or Absence of Paclitaxel in Tissues Obtained at Prostatectomy

Overall Study

Behaviors and Mental Disorders

Erectile Dysfunction

* GTV represents MR defined dominant radiographic disease, if identifiable.
* CTV encompasses the full prostate. At physician's discretion, the insertion of the seminal vesicle upon the prostate on slices containing prostate may be included.
* PTV1_30Gy will not be used or created on this arm
* PTV2_SAbR40Gy OR PTV2_SAbR45Gy will be generated by a 3mm expansion on the CTV. PTV2_SAbR will receive 8-9 Gy per fraction for 5 fractions (40-45 Gy).

* GTV represents MR defined dominant radiographic disease, if identifiable.
* CTV encompasses the full prostate. At physician's discretion, the insertion of the seminal vesicle upon the prostate on slices containing prostate may be included.
* PTV1_30Gy represents a 3mm expansion on the CTV, excluding the neurovascular structures on the side to be spared (left or right). PTV1 will receive 6 Gy per fraction for 5 fractions (30 Gy).
* PTV2_SAbR40Gy OR PTV2_SAbR45Gy will be generated by subtracting a 5mm expansion around the neurovascular elements to be spared (at least one side, left or right) from PTV1. These neurovascular structures consist of the neurovascular bundle, penile bulb, and internal pudendal arteries (see 4.1.5.2.16). PTV2 will receive 8-9 Gy per fraction for 5 fractions (40-45 Gy).

PTV1_30Gy represents a 3mm expansion on the prostate (and proximal seminal vesicle per physician discretion), excluding the neurovascular structures on the side to be spared (left or right). PTV1 will receive 6 Gy per fraction for 5 fractions (30 Gy).

30Gy (Gray) planning target volume (PTV)

Reduction of dose to or 'sparing' of neurovascular structures during stereotactic ablative body radiotherapy (SAbR) for localized prostate cancer will improve retention of sexual potency, while retaining excellent oncologic control and other secondary health-related quality of life (HRQOL) endpoints.

Primary Objectives:

• To compare the decline in patient health-related quality of life (HRQOL) instrument-defined erectile dysfunction following stereotactic ablative body radiotherapy (SAbR) with or without neurovascular sparing

Secondary Objectives:

* Assess acute (within 3 months of treatment) and chronic (\>3 months after treatment) SAbR related GU and GI toxicities, as well as serial impact on HRQOL metrics over time
* Assess biochemical progression free survival, local recurrence, distant recurrence, and survival
* Evaluate simplified 'practical' secondary HRQOL sexual potency endpoints that can be compared to prior literature.

Exploratory Objectives:

* Evaluate feasibility of MRI BOLD/TOLD to be integrated as hypoxia monitoring sequences to standard already planned diagnostic and/or treatment planning MRI on the study in five patient pilot.
* Evaluate quality of spacer placement and its effect on dose to neurovascular structures
* Evaluate rate local recurrence in the area of sparing adjacent to the neurovascular elements by biopsy in those with biochemical progression.

This is a phase II randomized, multi-institution, open-label, patient and HRQOL endpoint assessor blinded study evaluating the ability of neurovascular element sparing SAbR to decrease erectile dysfunction. The study procedure is to reduce 2-year Expanded prostate cancer index composite (EPIC) sexual domain score decline by 50% (-20 to -10), there by improving potency preservation. This reduction is usually expected to observe in patients undergoing the treatment stereotactic ablative body radiotherapy (SAbR) to 40-45 Gy with rectal spacer +/- sparing of at least one side's neurovascular structures using dose-painting.

Primary Endpoint:

• The Expanded prostate cancer index composite (EPIC) health-related quality of life (HRQOL) instrument includes a sexual function domain, which is used to produce a composite score of 0-100 from 9 questions related to ability to achieve an erection with or without aids and participate in intercourse. The primary endpoint will be the mean 24-month decline in EPIC sexual function domain composite score.

Secondary Endpoints:

* Acute Genitourinary (GU) and Gastrointestinal (GI) toxicity is defined as grade 1-5 toxicity occurring prior to 270 days from the start of protocol treatment. It is graded based on CTCAE v4.0.
* Delayed GU and GI toxicity is defined as grade 1-5 toxicity occurring prior to 270 days from the start of protocol treatment. It is graded based on CTCAE v4.0.
* Non GU and GI toxicity up to six months post treatment.
* Biochemical failure Radiation therapy oncology group-American Society for Therapeutic Radiology and Oncology (RTOG-ASTRO) definition (also known as Phoenix definition) - Thus, when the Prostate Specific Antigen (PSA) rises by more than 2 ng/ml above the lowest level (nadir) achieved after treatment, biochemical failure has occurred and the date of the failure is recorded at the time the nadir plus 2 ng/ml level is reached. Patients should be followed for a minimum of 5 years on this study to evaluate this endpoint.
* Overall survival
* Disease-specific survival
* Clinical progression including local/regional and distant relapse
* HRQOL questionnaires (EPIC and SF-12)
* Erectile function medication and device aids tracked before and after therapy longitudinally
* Feasibility of MRI BOLD/TOLD in evaluating tumor hypoxia in no more than five patient pilot

Sample Size: To enroll 120 patients (60 patients in each treatment arm).

The sample size is estimated, first, assuming that neurovascular element sparing SAbR (experimental arm intervention) will result in a mean 24 month decline in EPIC (HRQOL instrument) sexual domain composite score of -20, as compared to a decline of -10 in a standard SAbR without neurovascular element sparing. A total sample size of 102 patients (51 patients in each treatment group) achieves 80% power to detect this difference of 10 in EPIC sexual domain composite score decline at 24 months after treatment, with an equal standard deviation of 20 in both groups and at a two-sided significance level of 0.10, using a two-sample t-test (effect size 0.50).

An attrition rate of EPIC sexual domain questionnaire completion at 2-years of 15% is anticipated, based upon yields from multi-center prospective trials in prostate cancer radiotherapy with EPIC HRQOL endpoints. A total of 120 patients will be accrued to account for this 15% attrition rate.

Statistical Analysis: For the primary endpoint, a two-sided two-sample t-test will be used to compare EPIC sexual function domain score composite declines at 24 months from treatment between experimental SAbR arms with and without neurovascular sparing. Our sample size of 60 patients in each arm gives a calculated 80% power to detect a difference of 10 (considered the minimally important difference for sexual domain) at a two-sided significance level 0.10, assuming an equal standard deviation of 20 in both groups and allowing for 15% attrition in survey completion. Secondary endpoints and their analysis methodology is further specified in the protocol.

Prostate Oncologic Therapy While Ensuring Neurovascular Conservation (POTEN-C)

A Phase II Randomized Controlled Trial of Stereotactic Ablative Body Radiotherapy (SAbR) With or Without Neurovascular Sparing for Erectile Function Preservation in Localized Prostate Cancer

To compare the decline in patient health-related quality of life (HRQOL) instrument-defined erectile dysfunction following stereotactic ablative body radiotherapy (SAbR) with or without neurovascular sparing. The Expanded Prostate Cancer Index Composite (EPIC) health-related quality of life (HRQOL) instrument includes four sub-scales like urinary function, bowel habits, sexual function, and hormonal function. The primary outcome (sexual function) which has a range score of 0-100 from 9 questions related to ability to achieve an erection with or without aids and participate in intercourse. Higher the score represents the better outcome. Individual responses are summed for a total score of sexual function.

Assess acute (within 3 months of treatment) and chronic (\>3 months after treatment) SAbR related GU and GI toxicities, as well as serial impact on HRQOL metrics over time. Severity or Toxicity will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. The consequences of gastointestinal/renal/genitourinary/sexual and reproductive toxicity should all be graded 1-5 according to the Common Terminology Criteria For Adverse Events (CTCAE), version 4.0 occurring prior to 270 days from the start of protocol treatment. Other treatment related toxicity attributed to the therapy will be captured, recorded and the consequences of should all be graded 1-5 according to the Common Terminology Criteria For Adverse Events (CTCAE). CTCAE V4.0 along with grades 1-5 is provided in the link for reference (https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf).

Assess biochemical progression free survival. Biochemical failure RTOG-ASTRO definition - when the PSA rises by more than 2 ng/ml above the lowest level (nadir) achieved after treatment, biochemical failure has occurred and the date of the failure is recorded at the time the nadir plus 2 ng/ml level is reached.

The time to progression will be measured from the date of study entry to the date of documented local progression as determined by clinical exam and/or MRI. Local progression is defined by progression within the prostate, seminal vesicles or immediately adjacent extracapsular soft tissue. Biopsy confirmation is not required but is encouraged.

The time to distant failure will be measured from the date of study entry to the date of documented regional nodal recurrence or distant disease relapse. Patients with evidence of biochemical failure, but a negative prostate biopsy, will be considered as distant failure only.

The survival time will be measured from the date of accession to the date of death. All patients will be followed for survival. Every effort should be made to document the cause of death.

Evaluate simplified 'practical' secondary HRQOL sexual potency endpoints that can be compared to prior literature. The Expanded Prostate Cancer Index Composite (EPIC) health-related quality of life (HRQOL) instrument includes four sub-scales like urinary function, bowel habits, sexual function, and hormonal function. The primary outcome (sexual function) which has a range score of 0-100 from 9 questions related to ability to achieve an erection with or without aids and participate in intercourse. Higher the score represents the better outcome. Individual responses are summed for a total score of sexual function.

Boston Scientific Corporation

University of Texas Southwestern Medical Center

Associate Professor of Medicine

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Performing nerve-sparing robot-assisted laparoscopic radical prostatectomy by IV injecting of Indocyanine Green

Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green

Nerve-sparing robot-assisted laparoscopic radical prostatectomy using Indocyanine Green

using Indocyanine Green

Nerve-sparing robot-assisted laparoscopic radical prostatectomy

Araz Musaev, Dr

Araz Musaev

Imaging of the vascular nerve bundle using Indocyanine Green

Comparison of erectile function and surgical margin positivity after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery performed by imaging the vascular nerve bundle using Indocyanine Green with the results after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery without Indocyanine Green

Use of Indocyanine Green in Robotic Prostate Surgeries

Evaluation of the Effect of Intraoperative Indocyanine Green Use on Erectile Function and Surgical Margin Positivity in Patients Undergoing Nerve-Sparing Robot-Assisted Laparoscopic Radical Prostatectomy

Evaluation of erectile function after Nerve Sparing Robot Assisted Laparoscopic Radical Prostatectomy with and without the application of Indocyanine Green.Evaluation of surgical margin positivity after Nerve Sparing Robot Assisted Laparoscopic Radical Prostatectomy with and without the application of Indocyanine Green.

Both groups will evaluate their erectile function by completing the preoperative International Index of Erectile Function Every groups of participants will fill the International Index of Erectile Function -5 again after surgery in 3. -6. -9. -12 months.

The possible scores for the International Index of Erectile Function- 5 range from 0 to 30, and Erectile disfonction is classified into five categories based on the scores: severe (0-10), moderate (11-16), mild to moderate (17-21), mild (22-25), and no erectile disfonction (26-30).

Postoperative surgical margin positivity will be compared in both groups according to the results of the postoperative pathology report. Surgical margin positivity in both groups will be evaluated as a percentage and it will be evaluated whether there is a significant difference between the two groups

Ankara University

Principal İnvesitgator

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Control group will receive an immediate prostatectomy.

Cabozantinib 40 mg by mouth daily for 4 weeks.

Cabozantinib

Radical prostatectomy as part of routine medical care.

Radical Prostatectomy

Michael Harrison, MD

This is a prospective, randomized, open-label, phase II trial of cabozantinib in subjects with untreated, high risk prostate cancer undergoing radical prostatectomy. This multicenter study will enroll 30 subjects. Duke is the lead site for this trial. There will be a second site selected TBD.

Patients will be assigned (first 9 subjects only) or randomized 2:1 to either: (1) cabozantinib 40 mg by mouth daily for 4 weeks, followed by a 2 week drug washout period before prostatectomy (n = 20), or (2) immediate prostatectomy within 12 weeks of registration (n = 10). The first 9 subjects (6 subjects assigned to cabozantinib treatment, 3 subjects assigned to immediate prostatectomy) will constitute the Safety Lead-In Cohort, which will be only accrued at Duke. After six subjects have received cabozantinib and completed the 57-85 day safety visit without triggering a stopping rule, subjects may be accrued at the ex-Duke site.

The primary goal is to compare pathologic apoptotic indices (cleaved caspase-3) in prostatectomy specimens from patients who undergo immediate prostatectomy (controls) versus those who receive with cabozantinib followed by prostatectomy. The secondary objective is to conduct immune phenotypic profiling on the peripheral blood and tumor microenvironment in prostatectomy specimens from both groups. A statistical analysis will be used to compare the apoptotic indices between the two groups.

Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer

A Phase II, Open-Label Randomized Study of Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer (SPARC)

Apoptotic index as measured by cleaved caspase-3 levels in tumor tissue

Percentage of MDSCs in peripheral blood and tumor tissue

Percentage of neutrophils in peripheral blood and tumor tissue

Percentage of M1 macrophages in peripheral blood and tumor tissue

Percentage of M2 macrophages in peripheral blood and tumor tissue

Percentage of CD8+ positive cells in tumor tissue

Percentage of PD-L1 positive cells in tumor tissue

Percentage of CTLA-4 positive cells in tumor tissue

Percentage of IL-1RA positive cells in tumor tissue

Percentage of neutrophil chemotactic factor CXCL12 positive cells in tumor tissue

Percentage of neutrophil chemotactic factor HMGB1 positive cells in tumor tissue

Percentage of MDSC-promoting cytokine CCL5 positive cells in tumor tissue

Percentage of MDSC-promoting cytokine CCL12 positive cells in tumor tissue

Percentage of MDSC-promoting cytokine CD40 cells in tumor tissue

Exelixis

Duke University

Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Cabozantinib Followed by Prostatectomy (Arm A)

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Immediate Prostatectomy (Arm B)

Total

United States

Region of Enrollment

Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B).

Michael Harrison, M.D.

Apoptotic Index in Prostatectomy Specimens From Patients Who Undergo Immediate Prostatectomy (Arm B) Versus Those Treated With Cabozantinib Followed by Prostatectomy (Arm A)

Immune Phenotyping of Myeloid-derived Suppressor Cells (MDSCs)

Immune Phenotyping of Neutrophils

Immune Phenotyping of M1 Macrophages

Immune Phenotyping of M2 Macrophages

Immunohistochemical (IHC) Analysis of CD8+

Immunohistochemical (IHC) Analysis of Programmed Death Ligand-1 (PD-L1)

Immunohistochemical (IHC) Analysis of Cytotoxic T-lymphocyte-associated Protein 4 (CTLA-4)

Immunohistochemical (IHC) Analysis of Interleukin-1 Receptor Antagonist (IL-1RA)

Description of the Neutrophil Chemotactic Factor CXCL12

Description of the Neutrophil Chemotactic Factor HMGB1

Description of the MDSC-promoting Cytokine CCL5

Description of the MDSC-promoting Cytokine CCL12

Description of the MDSC-promoting Cytokine CD40

External beam radiotherapy, 5 additional MRI scans, blood sampling

SBRT technique with 35 Gy in 5 weekly fractions and an additional simultaneously integrated focal boost to the tumor nodule(s) visible on MRI up to 50 Gy. In addition, patients will be asked to undergo 5 additional MRI scans (\~15 min/scan) without contrast enhancement prior to each radiation session as well as blood sampling for translational research (radiogenomics) and Biobank purposes.

Hypo-FLAME study

Linda GW Kerkmeijer, MD, PhD

The hypo-FLAME study is a multicenter phase II study (n=100) to investigate whether a focal SBRT boost to the MRI-defined macroscopic tumor volume is feasible and associated with acceptable toxicity in addition to whole gland prostate SBRT.

Rationale: Hypofractionation with a stereotactic body radiotherapy (SBRT) technique for prostate cancer produces excellent treatment outcome in terms of survival and toxicity and is much more convenient than the current fractionation scheme. Local recurrence occurs most frequently at the site of the primary or dominant tumor location prior to treatment. Therefore dose escalation at the site of the primary tumor may improve disease control.

Objective: The main goal of this phase II study is to investigate whether a focal ablative SBRT boost to the macroscopic tumor is feasible and associated with acceptable toxicity in addition to whole gland prostate SBRT. The secondary objectives of this study are: late toxicity, quality of life (QoL) and biochemical disease free survival (bDFS). Furthermore, two side-studies are incorporated in this phase II study: 1) a weekly MRI will be performed to prepare for future MRI-guided (MR-linac) treatment without gold fiducial markers and 2) blood sampling for translational research (radiogenomics) and Biobank purposes.

Study design: Prospective multicenter interventional study on whole gland prostate SBRT using MRI for focal boost in 100 consecutive intermediate or high risk prostate cancer patients.

Study population: One hundred patients with histologically proven prostate adenocarcinoma with intermediate risk or high risk disease. Patients referred for external beam radiotherapy (EBRT) who fulfill the inclusion criteria and without any of the exclusion criteria will be included in the present trial after written informed consent.

Intervention: Patients will be treated by external beam radiotherapy with a SBRT technique with 35 Gy in 5 weekly fractions and an additional simultaneously integrated focal boost to the tumor nodule(s) visible on MRI up to 50 Gy. In addition, patients will be asked to undergo 5 additional MRI scans (\~15 min/scan) without contrast enhancement prior to each radiation session as well as blood sampling for translational research (radiogenomics) and Biobank purposes.

Main study parameters/endpoints: The primary endpoints of this study are acute gastrointestinal (GI) and genitourinary (GU) toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Secondary endpoints are late GI and GU toxicity, QoL, and bDFS. Simultaneously, two side-studies will be performed, i.e. to prepare for MRI-guided radiotherapy and blood sampling for translational research (radiogenomics) and Biobank purposes.

Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer

Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer (Hypo-FLAME)

Quantify intrafraction motion of the prostate (in mm)

The goal of the present study is to investigate whether a focal SBRT boost to the macroscopic tumor is feasible and associated with acceptable toxicity in addition to whole gland prostate SBRT. Toxicity will be assessed by the acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Acute toxicity is defined as toxicity occurring within 90 days after the first radiation treatment.

Late toxicity, assessed by the late GI and GU Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Late toxicity is defined as toxicity occurring after at least 90 days after the first radiation treatment.

European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
18F-DCFPyL PET-CT Scan and Prostate Cancer	NCT03852654	Prostate Cancer...	18F-DCFPyL	18 Years -	VA Greater Los Angeles Healthcare System
Trial of NanoPac Focal Therapy for Prostate Cancer	NCT04221828	Prostate Cancer Prostate Adenoc... Prostate Cancer... Prostatic Neopl... Urogenital Neop... Genital Neoplas... Localized Cance...	NanoPac (steril...	18 Years -	NanOlogy, LLC
18F-DCFPyL PET-CT Scan and Prostate Cancer	NCT03852654	Prostate Cancer...	18F-DCFPyL	18 Years -	VA Greater Los Angeles Healthcare System
Prostate Oncologic Therapy While Ensuring Neurovascular Conservation (POTEN-C)	NCT03525262	Prostate Cancer...	30Gy (Gray) pla...	18 Years -	University of Texas Southwestern Medical Center
Use of Indocyanine Green in Robotic Prostate Surgeries	NCT05960149	Prostate Cancer... Erectile Dysfun...	using Indocyani... Nerve-sparing r...	- 75 Years	Ankara University
Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer	NCT03964337	Prostate Cancer Prostate Cancer... Non-Metastatic	Cabozantinib Radical Prostat...	18 Years -	Duke University
Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer	NCT02853110	Prostate Cancer...	Hypo-FLAME stud...	18 Years - 100 Years	UMC Utrecht
Use of Indocyanine Green in Robotic Prostate Surgeries	NCT05960149	Prostate Cancer... Erectile Dysfun...	using Indocyani... Nerve-sparing r...	- 75 Years	Ankara University

Spots Global Cancer Trial Database for prostate cancer adenocarcinoma