New York, NYNCT03067051Now EnrollingIRB Ready

Recurrent Prostate Cancer Clinical Trial in New York, NY

Access cutting-edge recurrent prostate cancer treatment through this phase 1/2 clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by SpectraCure AB

Quick Self-Assessment

See if you qualify for this New York location

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Expert Care in New York

Access recurrent prostate cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related recurrent prostate cancer treatment provided free

Apply for This New York Location

Check if you qualify for this recurrent prostate cancer clinical trial in New York, NY

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Recurrent Prostate Cancer Study in New York

The rationale for the study is to obtain safety and efficacy data as well as to establish dose parameters for the SpectraCure P18 System with IDOSE®, with verteporfin for injection (VFI) as photosensitizer for the treatment of recurrent prostate cancer.

Sponsor: SpectraCure AB

Who Can Participate

Inclusion Criteria

Males \> 18 years who have gone through external or internal, high dose rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.
Prostate volume less than 50 cm3 defined by transrectal ultrasound
Subject not eligible for surgery or curative radiotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Expected survival ≥ 8 months
Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3
Adequate renal function as defined by creatinine ≤ 1.5 mg /dl
Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamate-oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal
Signed Informed Consent Phase 1

Exclusion Criteria

Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease
Patients who have been treated with seed implantation brachytherapy
Gleason score ≥ 8 at initial diagnosis
Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)
Concomitant infection
Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study
Mental incapacity or psychiatric illness that would interfere with the subject's ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator
Contraindication for photosensitizer
Porphyria or other diseases exacerbated by light
Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients
Known allergies to porphyrins
Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site
On-going therapy with a photosensitizing agent
Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
Subjects with a history of CTCAE v4 grade 3 or greater or persistent (\>1 separate episode or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation. Phase 2 Inclusion Criteria:
Subjects \> 18 years who have gone through external or internal, high dose-rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.
Treatment target volume less than 50 cm3.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Expected survival ≥ 12 months.
Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamate- oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.
Signed Informed Consent. Phase 2 Exclusion Criteria:
Subjects with locally advanced (AJCC 7th edition T3/T4), regional pelvic lymph node metastasis, or metastatic disease defined by PSMA PET.
Subjects who have been treated with seed implantation brachytherapy.
Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).
Concomitant infection.
Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.
Mental incapacity or psychiatric illness that would interfere with the subject's ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator.
Contraindication for photosensitizer.
Porphyria or other diseases exacerbated by light.
Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.
Known allergies to porphyrins.
Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
On-going therapy with a photosensitizing agent.
Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
Subjects with a history of CTCAE v4 grade 3 or greater or persistent (\>1 separate episode or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation.
Contraindication for MRI/Gadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate \[GFR\] \<30 mL/min/1.73m2, or previous contrast reactions.
On-going or planned hormone therapy.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT03067051) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Recurrent Prostate Cancer Treatment Options in New York, NY

If you're searching for recurrent prostate cancer treatment options in New York, NY, this clinical trial (NCT03067051) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced recurrent prostate cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all recurrent prostate cancer clinical trials near you to find additional studies recruiting in your area.

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