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NCT01655836
High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
Phase 1 trial testing Brachytherapy in Prostate Cancer in 42 participants. Participants enrolled and being followed up; not accepting new ones.
27 July 2016
Quick facts
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 4 October 2012 |
| Primary completion | 27 July 2016 |
| Estimated completion | 1 January 2040 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Brachytherapy — full drug profile →
- Stereotactic Body Radiation Therapy — full drug profile →
- Quality-of-life assessment
- Questionnaire administration
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
- Adenocarcinoma of the Prostate — all drugs for Adenocarcinoma of the Prostate →
- Recurrent Prostate Cancer — all drugs for Recurrent Prostate Cancer →
- Stage IIA Prostate Cancer — all drugs for Stage IIA Prostate Cancer →
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Who can join
18 and older, male only, with Prostate Cancer or Adenocarcinoma of the Prostate. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The first technology is called high dose rate brachytherapy. Brachytherapy is sometimes called internal radiation therapy. High dose rate brachytherapy is a procedure that involves temporarily placing radioactive material inside the patient's body for about 10-20 minutes. Then, the remainder of the radiation treatment will be given over a 3 week period using stereotactic body radiation therapy (SBRT). SBRT is a novel treatment modality that involves the delivery of very high individual doses of radiation to tumors with high precision. This allows the doctor to deliver the same amount of radiation in a much shorter time. The purpose of this study is to determine the safety of brachytherapy when combined with hypofractionated SBRT.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Review of brachytherapy clinical trials: a cross-sectional analysis of ClinicalTrials.gov.
Chen D, Parsa R, Chauhan K, Lukovic J, et al · · 2024 · cited 2× · PMID 38351013 · DOI 10.1186/s13014-024-02415-8
Verify or expand the search:
- PubMed search for NCT01655836
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Brachytherapy
Trials testing the same drug.
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- NCT07182279 — Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer · Phase 1, PHASE2 · recruiting
- NCT06543576 — External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for the Treatment of Stage IVB Cer · Phase 1, PHASE2 · recruiting
- NCT06333821 — A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma · Phase 3 · not yet recruiting
- NCT06129851 — Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer · Phase 2 · not yet recruiting
Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
- NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
- NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
- NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
- NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
Other Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University trials
Trials by the same sponsor.
- NCT06974981 — Leveraging Lung Cancer Screening to Optimize Screening Outcomes and COPD Management: COPD in LCS Registry · recruiting
- NCT03796884 — Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer · Phase 2 · active not recruiting
- NCT03712904 — Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma · Phase 2 · terminated
- NCT03807492 — Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR) · completed
- NCT03477864 — Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progres · Phase 1 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01655836 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Last refreshed: 11 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01655836.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing