AS research survey: your help still needed

As of Friday (July 22), we had received more than 250 responses to our brief survey on research into active surveillance. Most of these are from patients and some from their familial supporters (spouses, partners, etc.). However,we are still interested in getting more input — especially from clinicians, including specialists, generalists, and allied health personnel like urology nurses! … READ MORE …

Helpful upcoming webinars this week

Three more upcoming webinars this week will deal with (a) the work-up of men with prostate cancer prostate cancer who progress after first-line therapy (such as surgery, radiation, etc.); (b) whether Gleason 6 disease should really be defined as “prostate cancer”; and (c) an update on the most current information related to the evaluation and management of men with prostate cancer appropriate for active surveillance. … READ MORE …

Three helpful upcoming webinars

Three upcoming webinars deal with (a) the diagnosis and work-up of clinically significant forms of localized prostate cancer; (b) handling anxiety and related issues for men on active surveillance (AS); and (c) whether AS is appropriate for African Americans and others of African ethnicity. See below for details. … READ MORE …

Research on AS in management of prostate cancer: your input is important!

A diverse group of patients, patient advocates, patient spouses/supporters, physicians, and other researchers has come together, with funding support from the Patient Centered Outcomes Research Institute (PCORI), to plan a virtual conference for the fall of 2021. At that conference, we intend to discuss and identify new and evolving opportunities for research into the most appropriate, high-need, high-impact topics affecting the use of active surveillance (AS) for the management of favorable-risk forms of prostate cancer (i.e., low-risk and “favorable” intermediate-risk disease). … READ MORE …

Extending OS on initial ADT for men with mHSPC

Back in 1989, the SWOG 8494 trial first showed that adding an antiandrogen (flutamide) to bilateral medical orchiectomy with an LHRH agonist (leuprolide acetate) extended median overall survival (OS) by 7 months in newly diagnosed men with metastatic, hormone-sensitive prostate cancer (mHSPC). … READ MORE …

Lower salvage radiation dose — are outcomes the same?

A large randomized clinical trial, SAKK 09/10, found that a salvage radiation dose of 64 Gy over 32 treatments had equivalent biochemical outcomes compared to 70 Gy over 35 treatments. … READ MORE …

Brief, intense radiation and hormone therapy for very high-risk prostate cancer

As we’ve seen, brachy boost therapy seems to have the best oncological results for men with very high-risk prostate cancer. … READ MORE …

Early data from the PEACE-1 trial

The so-called PEACE-1 trial is an ongoing Phase III trial among men diagnosed with de novo metastatic castration-sensitive prostate cancer (mCSPC). … READ MORE …

FDA approves Pylarify for diagnosis of advanced/recurrent forms of prostate cancer

In ,a recent media release, Lantheus Holdings announced that the US Food and Drug Administration (FDA) had approved the imaging agent known as piflufolastat F 18 Injection (also known as Pylarify® or more commonly just “PyL”) as a PSMA-based PET imaging agent for identification of prostate cancer. … READ MORE …

First clinical trial of Lu-177-PSMA-617 in recurrent, hormone-sensitive men

While we expect only a few months of extra survival from the VISION trial of Lu-177-PSMA-617 in heavily pretreated, metastatic, castration-resistant men (see this link), we hope to get more out of the radiopharmaceutical if used earlier.

Privé et al. reported the results of a pilot trial in 10 recurrent men treated with Lu-177-PSMA-617 at Radboud University in Nijmegen, The Netherlands. They were all:

  • Recurrent after prostatectomy ± salvage radiation (PSA > 0.2 ng/ml)
  • Rapid PSA doubling time (< 6 months)
  • Between 1-10 metastases detectable on a PSMA PET scan or USPIO MRI
  • At least 1 metastasis > 1 cm
  • Unable to receive SBRT to metastases
  • No visceral metastases
  • Have not begun salvage ADT
  • Treated with a low dose (3 GBq) on day 1; second treatment (~6 GBq) after 8 weeks (compared to dose in VISION trial of 7.4 GBq in each of 4 to 6 cycles)

After 24 weeks of follow-up after Cycle 2:

  • 5 patients had PSA reduced by > 50 percent (1 undetectable)
  • 2 patients had stable PSA
  • 3 patients had PSA progression
  • 6 patients had a radiographic response
  • 4 patients had radiographic progression
  • ADT-deferred survival was 9.5 months (median)
  • Those with lymph node only metastases had the best response
  • Those with any bone metastases had lesser response

After a second dose, comparing their 24-week PSA to their 12-week PSA:

  • PSA was continuing to decline in 3 patients
  • PSA was rising again in 6 patients
  • Side effects were mild (no grade 3) and transient:
    • Fatigue in 7;nausea in 3
    • Dry mouth (xerostomia) in 2

There are lots more questions than answers:

  • Would a higher dose and more treatments be more effective?
  • Would a higher dose and more treatments be more toxic?
  • Is it like Xofigo in that it’s more effective with micrometatases? If so, would a combination with SBRT targeted at the larger metastases be more effective?
  • Since it was more effective on lymph nodes, would it make a good combination with Xofigo for patients who have both lymph node and bone metastases? (See also Th-227-PSMA.)
  • Because there seems to be a continued abscopal effect for some patients, would combining it with Provenge be optimal?
  • Would pretreatment with ADT or a new anti-androgen (Xtandi, Erleada or Nubeqa) increase expression of PSMA, and increase radiosensitivity?
  • Can we predict who will benefit?

Use in other patient populations remains to be explored: high-risk, newly diagnosed metastatic, castration-resistant but chemo-naive. Optimal sequencing with other therapies remains to be explored.

Editorial note: This commentary was written by Alan Edel for The “New” Prostate Cancer InfoLink.

Lutetium-177 PSMA-617 in treatment of mCRPC: trial results

According to a media release, issued earlier today by Novartis, the company has provided preliminary data about the results of the international, multi-center, Phase III, randomized, VISION trial, which has been evaluating the efficacy and safety of lutetium-177 PSMA-617, a targeted radioligand therapy, in treatment of men with progressive, PSMA-positive, metastatic, castration-resistant prostate cancer (mCRPC) … READ MORE …

Active surveillance and related research: a new research initiative

As some of our readers will already be aware, Prostate Cancer International has been working in concert with Dr. M. Mihaj Siddiqui at the University of Maryland School of Medicine and the PATIENTS program at the University of Maryland School of Pharmacy to put together a grant request for funding for a program to identify evidence gaps to guide future research on the use of active surveillance to monitor low-risk prostate cancers. … READ MORE …

Modulating personal bias in provision of prostate cancer “support” services

As Howard Wolinsky has been learning over the past few years, not all prostate cancer support groups are “equal” — in the sense that individual support group leaders may be seriously biased by their own personal experiences (which may have occurred many years ago). … READ MORE …

Major new survey on active surveillance and prostate cancer

In February, a group of researchers initiated a major new survey of patient knowledge about active surveillance as an initial management option for men with lower risk forms of prostate cancer. … READ MORE …

Xofigo 2.0

Xofigo (radium Ra 223 dichloride) is a systemic radiopharmaceutical. Radium is chemically similar to calcium and is taken up by bones in places where bone is actively growing, as in prostate cancer bone metastases. … READ MORE …