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Proton Therapy for High Risk Prostate Cancer | Clinical Trials | Clareo Health

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Proton Therapy for High Risk Prostate Cancer

Phase 2/3 Study of Dose-escalated External Beam Radiation Therapy

NCT01811810•Abramson Cancer Center at Penn Medicine

Summary

The most common treatment for men with high risk prostate cancer is radiation therapy (XRT) followed by long term androgen deprivation therapy (ADT). Long-term AD is toxic, with substantial metabolic, physical, mental and sexual side-effects. In this study, the investigators propose a treatment strategy to optimize the control of high risk prostate cancer by using dose-escalated external beam radiation (proton therapy or IMRT) concurrent with docetaxel and adjuvant short-course AD. The investigators hypothesize that this approach will be superior to the current standard of care and obviate the need for long term AD. In this study, subjects will be randomized to either XRT with long term ADT or XRT and chemotherapy and short term ADT.

Eligibility

Age

18 - 75 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed prostate adenocarcinoma (within 365 days of randomization).
•High-risk for recurrence as determined by evidence of at least one of the following: Gleason Score 8-10 PSA 20 T stage T3
•Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-10. 6 cores are strongly recommended.
•Clinical stages T1a- T3 N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.-appendix III).
•PSA values 50 ng/ml within 90 days prior to randomization. Must be completed prior to biopsy or at least 21 days after prostate biopsy.
•Absolute Neutrophil Count (ANC) 1,800 cells/mm³ within 90 days prior to randomization.
•Platelets 100,000 cells/mm³ within 90 days prior to randomization.
•Hemoglobin 10 g/dl within 90 days prior to randomization. 3.1.9 ALT, AST, and total bilirubin within 1.5 X institutional upper normal limits within 90 days prior to randomization.
•ECOG status 0-1 (appendix II) documented within 90 days of randomization.
•Patient must sign study specific informed consent prior to randomization. Note: consent for legally authorized representative is not permitted.
+5 more criteria

Exclusion Criteria

•Evidence of distant metastasis.
•Pelvic lymph nodes 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
•Prior prostate cancer surgery including but not limited to prostatectomy, hyperthermia and cryosurgery.
•Prior pelvic radiation for their prostate cancer.
•Prior androgen suppression.
•Severe, active co-morbidity, defined as follows:
•Active rectal diverticulitis, Crohns disease affecting the rectum or ulcerative colitis. (Non-active diverticulitis and Crohns disease not affecting the rectum are allowed).
•Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
•Myocardial infarction within the last 6 months.
•Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization.
+7 more criteria

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

March 1, 2013

Primary Completion Date

April 1, 2014

Completion Date

April 1, 2014

Last Updated

April 23, 2019

Conditions

Prostate Cancer

Interventions

Radiation therapy (XRT)

RADIATION

Androgen Deprivation Therapy (ADT)

OTHER

Chemotherapy

OTHER

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Proton Therapy for High Risk Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC